## Protocol Section
### Identification Module
**NCT ID:** NCT00124579

**Brief Title:** S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

**Official Title:** S0417 A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma

#### Organization Study ID Info
**ID:** S0417
#### Organization
**Class:** NETWORK
**Full Name:** SWOG Cancer Research Network
#### Secondary ID Infos
**Domain:** SWOG
**ID:** S0417
**Type:** OTHER
**ID:** U10CA032102
**Link:** https://reporter.nih.gov/quickSearch/U10CA032102
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-09

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-13

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-04-19

**Type:** ESTIMATED

**Results First Submit Date:** 2013-01-02

**Results First Submit QC Date:** 2013-03-08

#### Start Date
**Date:** 2005-08

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2005-07-28
**Type:** ESTIMATED
**Study First Submit Date:** 2005-07-26
**Study First Submit QC Date:** 2005-07-26
**Why Stopped:** poor accrual
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** NETWORK

**Name:** SWOG Cancer Research Network

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.

**Detailed Description:** OBJECTIVES:

* Determine the confirmed overall response rate (complete remission, remission, and partial remission) in patients with relapsed or refractory multiple myeloma treated with bortezomib, thalidomide, and dexamethasone.
* Determine overall and progression-free survival of patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Correlate, preliminarily, treatment with bortezomib with the activation of osteoblasts in these patients.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral thalidomide once daily on days 1-21, and oral dexamethasone once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days until achievement of confirmed complete remission (CR), remission (R), or partial remission (PR) OR for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving confirmed CR, R, or PR who reach a plateau prior to receiving the maximum 8 courses of induction therapy OR who achieve confirmed CR, R, or PR after receiving the maximum 8 courses of induction therapy proceed to maintenance therapy. Patients achieving stable disease after receiving the maximum 8 courses of induction therapy either proceed to maintenance therapy or receive further treatment with bortezomib, thalidomide, and dexamethasone off-study.

* Maintenance therapy: Patients receive oral dexamethasone on days 1-4. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 30 days and then every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.

### Conditions Module

**Conditions:**

- Multiple Myeloma

**Keywords:**

- stage I multiple myeloma

- stage II multiple myeloma

- stage III multiple myeloma

- refractory multiple myeloma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 7

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** bortezomib with thalidomide and dexamethasone

**Intervention Names:**

- Drug: bortezomib

- Drug: dexamethasone

- Drug: thalidomide

**Label:** bortezomib with thalidomide and dexamethasone

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- bortezomib with thalidomide and dexamethasone

**Description:** induction: 1 mg/m2 IV push days 1, 4, 8, 11 every 21 days

**Name:** bortezomib

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- bortezomib with thalidomide and dexamethasone

**Description:** induction: 20 mg/d PO days 1, 2, 4, 5, 8, 9, 11, 12 every 21 days maintenance: 40 mg days 1-4 every 28 days until progression

**Name:** dexamethasone

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- bortezomib with thalidomide and dexamethasone

**Description:** 100 mg/d PO days 1-21 every 21 days

**Name:** thalidomide

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Responses are defined as follows:

Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.

Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein \< 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.

Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.

**Measure:** Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** To evaluate the qualitative and quantitative toxicities associated with this regimen.

**Measure:** Toxicity Evaluation

**Time Frame:** From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years

**Description:** From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years

**Measure:** Progression-Free Survival

**Time Frame:** about 12-18 months

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma (MM)

  * Active disease
* Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation

  * Relapse is defined as the occurrence of any of the following during or after prior treatment:

    * Myeloma protein level increase by \> 100% from the lowest previously recorded level
    * Myeloma protein level increase above the defined response criteria for partial remission
    * Reappearance of any myeloma peak that had disappeared during the prior treatment
    * Increase in the size and number of lytic bone lesions and/or focal lesions by x-ray, MRI, positron emission tomography, and/or CT scan
  * Refractory disease is defined as no response (i.e., not achieving complete remission, remission, or partial remission) to prior therapy
* Measurable disease
* No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome
* Must be registered on protocol SWOG-S0334

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Zubrod 0-2 (unless due to bone pain)

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 50,000/mm\^3

Hepatic

* AST or ALT ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ 3 times ULN

Renal

* Creatinine clearance \> 30 mL/min

Cardiovascular

* No New York Heart Association class III or IV congestive heart failure
* No myocardial infarction within the past 6 months
* No poorly controlled hypertension

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use effective double method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for 4 weeks after completion of study treatment for male patients)
* No blood, ova, or sperm donation during study treatment
* No active infection requiring antibiotics
* No neurotoxicity ≥ grade 2
* No diabetes mellitus
* No other serious medical or psychiatric illness that would preclude study treatment
* No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered

Endocrine therapy

* Not specified

Radiotherapy

* At least 14 days since prior radiotherapy and recovered

Surgery

* Not specified

Other

* No prior bortezomib alone or combined with thalidomide
* Concurrent participation on protocol SWOG-S0309 allowed

**Maximum Age:** 120 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Little Rock

**Country:** United States

**Facility:** Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

**State:** Arkansas

**Zip:** 72205

**Location 2:**

**City:** Alton

**Country:** United States

**Facility:** Saint Anthony's Hospital at Saint Anthony's Health Center

**State:** Illinois

**Zip:** 62002

**Location 3:**

**City:** Mount Vernon

**Country:** United States

**Facility:** Good Samaritan Regional Health Center

**State:** Illinois

**Zip:** 62864

**Location 4:**

**City:** Naperville

**Country:** United States

**Facility:** Hematology Oncology Consultants - Naperville

**State:** Illinois

**Zip:** 60540

**Location 5:**

**City:** Springfield

**Country:** United States

**Facility:** Regional Cancer Center at Memorial Medical Center

**State:** Illinois

**Zip:** 62781-0001

**Location 6:**

**City:** Beech Grove

**Country:** United States

**Facility:** St. Francis Hospital and Health Centers - Beech Grove Campus

**State:** Indiana

**Zip:** 46107

**Location 7:**

**City:** Richmond

**Country:** United States

**Facility:** Reid Hospital & Health Care Services, Incorporated

**State:** Indiana

**Zip:** 47374

**Location 8:**

**City:** Davenport

**Country:** United States

**Facility:** Genesis Regional Cancer Center at Genesis Medical Center

**State:** Iowa

**Zip:** 52803

**Location 9:**

**City:** Davenport

**Country:** United States

**Facility:** Genesis Medical Center - West Campus

**State:** Iowa

**Zip:** 52804

**Location 10:**

**City:** Salina

**Country:** United States

**Facility:** Tammy Walker Cancer Center at Salina Regional Health Center

**State:** Kansas

**Zip:** 67401

**Location 11:**

**City:** Wichita

**Country:** United States

**Facility:** Wesley Medical Center

**State:** Kansas

**Zip:** 67214

**Location 12:**

**City:** Ann Arbor

**Country:** United States

**Facility:** Saint Joseph Mercy Cancer Center

**State:** Michigan

**Zip:** 48106-0995

**Location 13:**

**City:** Ann Arbor

**Country:** United States

**Facility:** CCOP - Michigan Cancer Research Consortium

**State:** Michigan

**Zip:** 48106

**Location 14:**

**City:** Battle Creek

**Country:** United States

**Facility:** Battle Creek Health System Cancer Care Center

**State:** Michigan

**Zip:** 49017

**Location 15:**

**City:** Big Rapids

**Country:** United States

**Facility:** Mecosta County Medical Center

**State:** Michigan

**Zip:** 49307

**Location 16:**

**City:** Dearborn

**Country:** United States

**Facility:** Oakwood Cancer Center at Oakwood Hospital and Medical Center

**State:** Michigan

**Zip:** 48123-2500

**Location 17:**

**City:** Flint

**Country:** United States

**Facility:** Genesys Hurley Cancer Institute

**State:** Michigan

**Zip:** 48503

**Location 18:**

**City:** Flint

**Country:** United States

**Facility:** Hurley Medical Center

**State:** Michigan

**Zip:** 48503

**Location 19:**

**City:** Grand Rapids

**Country:** United States

**Facility:** CCOP - Grand Rapids

**State:** Michigan

**Zip:** 49503

**Location 20:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Lacks Cancer Center at Saint Mary's Health Care

**State:** Michigan

**Zip:** 49503

**Location 21:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Spectrum Health Hospital - Butterworth Campus

**State:** Michigan

**Zip:** 49503

**Location 22:**

**City:** Grand Rapids

**Country:** United States

**Facility:** Metro Health Hospital

**State:** Michigan

**Zip:** 49506

**Location 23:**

**City:** Grosse Pointe Woods

**Country:** United States

**Facility:** Van Elslander Cancer Center at St. John Hospital and Medical Center

**State:** Michigan

**Zip:** 48236

**Location 24:**

**City:** Holland

**Country:** United States

**Facility:** Holland Community Hospital

**State:** Michigan

**Zip:** 49423

**Location 25:**

**City:** Jackson

**Country:** United States

**Facility:** Foote Hospital

**State:** Michigan

**Zip:** 49201

**Location 26:**

**City:** Lansing

**Country:** United States

**Facility:** Sparrow Regional Cancer Center

**State:** Michigan

**Zip:** 48909

**Location 27:**

**City:** Muskegon

**Country:** United States

**Facility:** Hackley Hospital

**State:** Michigan

**Zip:** 49442

**Location 28:**

**City:** Port Huron

**Country:** United States

**Facility:** Mercy Regional Cancer Center at Mercy Hospital

**State:** Michigan

**Zip:** 48060

**Location 29:**

**City:** Saginaw

**Country:** United States

**Facility:** Seton Cancer Institute - Saginaw

**State:** Michigan

**Zip:** 48601

**Location 30:**

**City:** Southfield

**Country:** United States

**Facility:** Providence Cancer Institute at Providence Hospital - Southfield Campus

**State:** Michigan

**Zip:** 48075

**Location 31:**

**City:** Traverse City

**Country:** United States

**Facility:** Munson Medical Center

**State:** Michigan

**Zip:** 49684

**Location 32:**

**City:** Warren

**Country:** United States

**Facility:** St. John Macomb Hospital

**State:** Michigan

**Zip:** 48093

**Location 33:**

**City:** Cape Girardeau

**Country:** United States

**Facility:** Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

**State:** Missouri

**Zip:** 63701

**Location 34:**

**City:** Cape Girardeau

**Country:** United States

**Facility:** Saint Francis Medical Center

**State:** Missouri

**Zip:** 63703

**Location 35:**

**City:** Saint Louis

**Country:** United States

**Facility:** CCOP - St. Louis-Cape Girardeau

**State:** Missouri

**Zip:** 63141

**Location 36:**

**City:** Saint Louis

**Country:** United States

**Facility:** David C. Pratt Cancer Center at St. John's Mercy

**State:** Missouri

**Zip:** 63141

**Location 37:**

**City:** Springfield

**Country:** United States

**Facility:** CCOP - Cancer Research for the Ozarks

**State:** Missouri

**Zip:** 65802

**Location 38:**

**City:** Springfield

**Country:** United States

**Facility:** St. John's Regional Health Center

**State:** Missouri

**Zip:** 65804

**Location 39:**

**City:** Springfield

**Country:** United States

**Facility:** Hulston Cancer Center at Cox Medical Center South

**State:** Missouri

**Zip:** 65807

**Location 40:**

**City:** Billings

**Country:** United States

**Facility:** CCOP - Montana Cancer Consortium

**State:** Montana

**Zip:** 59101

**Location 41:**

**City:** Billings

**Country:** United States

**Facility:** Hematology-Oncology Centers of the Northern Rockies - Billings

**State:** Montana

**Zip:** 59101

**Location 42:**

**City:** Billings

**Country:** United States

**Facility:** Northern Rockies Radiation Oncology Center

**State:** Montana

**Zip:** 59101

**Location 43:**

**City:** Billings

**Country:** United States

**Facility:** St. Vincent Healthcare Cancer Care Services

**State:** Montana

**Zip:** 59101

**Location 44:**

**City:** Billings

**Country:** United States

**Facility:** Billings Clinic Cancer Center

**State:** Montana

**Zip:** 59107-5100

**Location 45:**

**City:** Billings

**Country:** United States

**Facility:** Billings Clinic - Downtown

**State:** Montana

**Zip:** 59107-7000

**Location 46:**

**City:** Bozeman

**Country:** United States

**Facility:** Bozeman Deaconess Cancer Center

**State:** Montana

**Zip:** 59715

**Location 47:**

**City:** Butte

**Country:** United States

**Facility:** St. James Healthcare Cancer Care

**State:** Montana

**Zip:** 59701

**Location 48:**

**City:** Great Falls

**Country:** United States

**Facility:** Big Sky Oncology

**State:** Montana

**Zip:** 59405

**Location 49:**

**City:** Great Falls

**Country:** United States

**Facility:** Great Falls Clinic - Main Facility

**State:** Montana

**Zip:** 59405

**Location 50:**

**City:** Great Falls

**Country:** United States

**Facility:** Sletten Regional Cancer Institute at Benefis Healthcare

**State:** Montana

**Zip:** 59405

**Location 51:**

**City:** Great Falls

**Country:** United States

**State:** Montana

**Zip:** 59405

**Location 52:**

**City:** Helena

**Country:** United States

**Facility:** St. Peter's Hospital

**State:** Montana

**Zip:** 59601

**Location 53:**

**City:** Kalispell

**Country:** United States

**Facility:** Glacier Oncology, PLLC

**State:** Montana

**Zip:** 59901

**Location 54:**

**City:** Kalispell

**Country:** United States

**Facility:** Kalispell Medical Oncology at KRMC

**State:** Montana

**Zip:** 59901

**Location 55:**

**City:** Kalispell

**Country:** United States

**Facility:** Kalispell Regional Medical Center

**State:** Montana

**Zip:** 59901

**Location 56:**

**City:** Missoula

**Country:** United States

**Facility:** Community Medical Center

**State:** Montana

**Zip:** 59801

**Location 57:**

**City:** Missoula

**Country:** United States

**Facility:** Guardian Oncology and Center for Wellness

**State:** Montana

**Zip:** 59804

**Location 58:**

**City:** Missoula

**Country:** United States

**Facility:** Montana Cancer Specialists at Montana Cancer Center

**State:** Montana

**Zip:** 59807-7877

**Location 59:**

**City:** Missoula

**Country:** United States

**Facility:** Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

**State:** Montana

**Zip:** 59807

**Location 60:**

**City:** Kearney

**Country:** United States

**Facility:** Good Samaritan Cancer Center at Good Samaritan Hospital

**State:** Nebraska

**Zip:** 68848-1990

**Location 61:**

**City:** Middletown

**Country:** United States

**Facility:** Tucker Center for Cancer Care at Orange Regional Medical Center

**State:** New York

**Zip:** 10940-4199

**Location 62:**

**City:** Charlotte

**Country:** United States

**Facility:** Presbyterian Cancer Center at Presbyterian Hospital

**State:** North Carolina

**Zip:** 28233-3549

**Location 63:**

**City:** Goldsboro

**Country:** United States

**Facility:** Wayne Memorial Hospital, Incorporated

**State:** North Carolina

**Zip:** 27534

**Location 64:**

**City:** Hendersonville

**Country:** United States

**Facility:** Pardee Memorial Hospital

**State:** North Carolina

**Zip:** 28791

**Location 65:**

**City:** Rutherfordton

**Country:** United States

**Facility:** Rutherford Hospital

**State:** North Carolina

**Zip:** 28139

**Location 66:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic Taussig Cancer Center

**State:** Ohio

**Zip:** 44195

**Location 67:**

**City:** Dayton

**Country:** United States

**Facility:** Grandview Hospital

**State:** Ohio

**Zip:** 45405

**Location 68:**

**City:** Dayton

**Country:** United States

**Facility:** Good Samaritan Hospital

**State:** Ohio

**Zip:** 45406

**Location 69:**

**City:** Dayton

**Country:** United States

**Facility:** David L. Rike Cancer Center at Miami Valley Hospital

**State:** Ohio

**Zip:** 45409

**Location 70:**

**City:** Dayton

**Country:** United States

**Facility:** Veterans Affairs Medical Center - Dayton

**State:** Ohio

**Zip:** 45428

**Location 71:**

**City:** Dayton

**Country:** United States

**Facility:** CCOP - Dayton

**State:** Ohio

**Zip:** 45429

**Location 72:**

**City:** Findlay

**Country:** United States

**Facility:** Blanchard Valley Medical Associates

**State:** Ohio

**Zip:** 45840

**Location 73:**

**City:** Independence

**Country:** United States

**Facility:** Community Oncology Group at Cleveland Clinic Cancer Center

**State:** Ohio

**Zip:** 44131

**Location 74:**

**City:** Kettering

**Country:** United States

**Facility:** Charles F. Kettering Memorial Hospital

**State:** Ohio

**Zip:** 45429

**Location 75:**

**City:** Middletown

**Country:** United States

**Facility:** Middletown Regional Hospital

**State:** Ohio

**Zip:** 45044

**Location 76:**

**City:** Troy

**Country:** United States

**Facility:** UVMC Cancer Care Center at Upper Valley Medical Center

**State:** Ohio

**Zip:** 45373-1300

**Location 77:**

**City:** Wooster

**Country:** United States

**Facility:** Cleveland Clinic - Wooster

**State:** Ohio

**Zip:** 44691

**Location 78:**

**City:** Wright-Patterson Air Force Base

**Country:** United States

**Facility:** United States Air Force Medical Center - Wright-Patterson

**State:** Ohio

**Zip:** 45433-5529

**Location 79:**

**City:** Xenia

**Country:** United States

**Facility:** Ruth G. McMillan Cancer Center at Greene Memorial Hospital

**State:** Ohio

**Zip:** 45385

**Location 80:**

**City:** Youngstown

**Country:** United States

**Facility:** Tod Children's Hospital

**State:** Ohio

**Zip:** 44501

**Location 81:**

**City:** Gresham

**Country:** United States

**Facility:** Legacy Mount Hood Medical Center

**State:** Oregon

**Zip:** 97030

**Location 82:**

**City:** Milwaukie

**Country:** United States

**Facility:** Providence Milwaukie Hospital

**State:** Oregon

**Zip:** 97222

**Location 83:**

**City:** Portland

**Country:** United States

**Facility:** Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

**State:** Oregon

**Zip:** 97210

**Location 84:**

**City:** Portland

**Country:** United States

**Facility:** Providence Cancer Center at Providence Portland Medical Center

**State:** Oregon

**Zip:** 97213-2967

**Location 85:**

**City:** Portland

**Country:** United States

**Facility:** CCOP - Columbia River Oncology Program

**State:** Oregon

**Zip:** 97225

**Location 86:**

**City:** Portland

**Country:** United States

**Facility:** Providence St. Vincent Medical Center

**State:** Oregon

**Zip:** 97225

**Location 87:**

**City:** Portland

**Country:** United States

**Facility:** Legacy Emanuel Hospital and Health Center & Children's Hospital

**State:** Oregon

**Zip:** 97227

**Location 88:**

**City:** Tualatin

**Country:** United States

**Facility:** Legacy Meridian Park Hospital

**State:** Oregon

**Zip:** 97062

**Location 89:**

**City:** Anderson

**Country:** United States

**Facility:** AnMed Cancer Center

**State:** South Carolina

**Zip:** 29621

**Location 90:**

**City:** Spartanburg

**Country:** United States

**Facility:** CCOP - Upstate Carolina

**State:** South Carolina

**Zip:** 29303

**Location 91:**

**City:** Spartanburg

**Country:** United States

**Facility:** Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

**State:** South Carolina

**Zip:** 29303

**Location 92:**

**City:** El Paso

**Country:** United States

**Facility:** Center for Cancer Medicine and Blood Disorders, PA

**State:** Texas

**Zip:** 79902

**Location 93:**

**City:** Fort Sam Houston

**Country:** United States

**Facility:** Brooke Army Medical Center

**State:** Texas

**Zip:** 78234

**Location 94:**

**City:** Houston

**Country:** United States

**Facility:** Baylor University Medical Center - Houston

**State:** Texas

**Zip:** 77030

**Location 95:**

**City:** Houston

**Country:** United States

**Facility:** Ben Taub General Hospital

**State:** Texas

**Zip:** 77030

**Location 96:**

**City:** Houston

**Country:** United States

**Facility:** Methodist Hospital

**State:** Texas

**Zip:** 77030

**Location 97:**

**City:** Houston

**Country:** United States

**Facility:** St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

**State:** Texas

**Zip:** 77030

**Location 98:**

**City:** Houston

**Country:** United States

**Facility:** Veterans Affairs Medical Center - Houston

**State:** Texas

**Zip:** 77030

**Location 99:**

**City:** Lackland Air Force Base

**Country:** United States

**Facility:** Wilford Hall Medical Center

**State:** Texas

**Zip:** 78236

**Location 100:**

**City:** Temple

**Country:** United States

**Facility:** CCOP - Scott and White Hospital

**State:** Texas

**Zip:** 76508

**Location 101:**

**City:** American Fork

**Country:** United States

**Facility:** American Fork Hospital

**State:** Utah

**Zip:** 84003

**Location 102:**

**City:** Cedar City

**Country:** United States

**Facility:** Sandra L. Maxwell Cancer Center

**State:** Utah

**Zip:** 84720

**Location 103:**

**City:** Logan

**Country:** United States

**Facility:** Logan Regional Hospital

**State:** Utah

**Zip:** 84321

**Location 104:**

**City:** Murray

**Country:** United States

**Facility:** Cottonwood Hospital Medical Center

**State:** Utah

**Zip:** 84107

**Location 105:**

**City:** Murray

**Country:** United States

**Facility:** Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

**State:** Utah

**Zip:** 84157

**Location 106:**

**City:** Ogden

**Country:** United States

**Facility:** McKay-Dee Hospital Center

**State:** Utah

**Zip:** 84403

**Location 107:**

**City:** Provo

**Country:** United States

**Facility:** Utah Valley Regional Medical Center - Provo

**State:** Utah

**Zip:** 84604

**Location 108:**

**City:** Saint George

**Country:** United States

**Facility:** Dixie Regional Medical Center - East Campus

**State:** Utah

**Zip:** 84770

**Location 109:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Latter Day Saints Hospital

**State:** Utah

**Zip:** 84103

**Location 110:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Utah Cancer Specialists at UCS Cancer Center

**State:** Utah

**Zip:** 84106

**Location 111:**

**City:** Danville

**Country:** United States

**Facility:** Danville Regional Medical Center

**State:** Virginia

**Zip:** 24541

**Location 112:**

**City:** Martinsville

**Country:** United States

**Facility:** Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

**State:** Virginia

**Zip:** 24115

**Location 113:**

**City:** Bellingham

**Country:** United States

**Facility:** St. Joseph Cancer Center

**State:** Washington

**Zip:** 98225

**Location 114:**

**City:** Bremerton

**Country:** United States

**Facility:** Olympic Hematology and Oncology

**State:** Washington

**Zip:** 98310

**Location 115:**

**City:** Mount Vernon

**Country:** United States

**Facility:** Skagit Valley Hospital Cancer Care Center

**State:** Washington

**Zip:** 98273

**Location 116:**

**City:** Seattle

**Country:** United States

**Facility:** Fred Hutchinson Cancer Research Center

**State:** Washington

**Zip:** 98104

**Location 117:**

**City:** Seattle

**Country:** United States

**Facility:** Harborview Medical Center

**State:** Washington

**Zip:** 98104

**Location 118:**

**City:** Seattle

**Country:** United States

**Facility:** Minor and James Medical, PLLC

**State:** Washington

**Zip:** 98104

**Location 119:**

**City:** Seattle

**Country:** United States

**Facility:** Group Health Central Hospital

**State:** Washington

**Zip:** 98112

**Location 120:**

**City:** Seattle

**Country:** United States

**Facility:** Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

**State:** Washington

**Zip:** 98122-4307

**Location 121:**

**City:** Seattle

**Country:** United States

**Facility:** Polyclinic First Hill

**State:** Washington

**Zip:** 98122

**Location 122:**

**City:** Seattle

**Country:** United States

**Facility:** University Cancer Center at University of Washington Medical Center

**State:** Washington

**Zip:** 98195-6043

**Location 123:**

**City:** Sedro-Woolley

**Country:** United States

**Facility:** North Puget Oncology at United General Hospital

**State:** Washington

**Zip:** 98284

**Location 124:**

**City:** Spokane

**Country:** United States

**Facility:** Cancer Care Northwest - Spokane South

**State:** Washington

**Zip:** 99202

**Location 125:**

**City:** Vancouver

**Country:** United States

**Facility:** Southwest Washington Medical Center Cancer Center

**State:** Washington

**Zip:** 98668

**Location 126:**

**City:** Wenatchee

**Country:** United States

**Facility:** Wenatchee Valley Medical Center

**State:** Washington

**Zip:** 98801-2028

**Location 127:**

**City:** Sheridan

**Country:** United States

**Facility:** Welch Cancer Center at Sheridan Memorial Hospital

**State:** Wyoming

**Zip:** 82801

#### Overall Officials

**Official 1:**

**Affiliation:** Sparrow Regional Cancer Center

**Name:** Gordan Srkalovic, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** The Cleveland Clinic

**Name:** Mohamad A. Hussein, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000020141

- Term: Hemostatic Disorders

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010265

- Term: Paraproteinemias

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006474

- Term: Hemorrhagic Disorders

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12058

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M27588

- Name: Neoplasms, Plasma Cell

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13178

- Name: Paraproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3947

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

### Condition Browse Module - Meshes

- ID: D000009101

- Term: Multiple Myeloma

- ID: D000054219

- Term: Neoplasms, Plasma Cell

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000007917

- Term: Leprostatic Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000006131

- Term: Growth Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M376

- Name: Bortezomib

- Relevance: HIGH

- As Found: 14 days

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M16559

- Name: Thalidomide

- Relevance: HIGH

- As Found: List

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000013792

- Term: Thalidomide

- ID: D000003907

- Term: Dexamethasone

- ID: D000069286

- Term: Bortezomib

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Bortezomib + Thal/Dex

**Description:** Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.

**ID:** EG000

**Other Num Affected:** 7

**Other Num at Risk:** 7

**Serious Number Affected:** 1

**Serious Number At Risk:** 7

**Title:** Bortezomib + Thal/Dex

**Frequency Threshold:** 5

#### Other Events

**Term:** Hemoglobin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** SVT and nodal arrhythmia - Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** SVT and nodal arrhythmia - Sinus bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Cushingoid appearance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Night blindness (nyctalopia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vision-blurred vision

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Watery eye (epiphora, tearing)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Distention/bloating, abdominal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Heartburn/dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Abdomen NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Edema: head and neck

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Edema: limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Extremity-lower (gait/walking)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Fatigue (asthenia, lethargy, malaise)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Fever in absence of neutropenia, ANC lt1.0x10e9/L

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain-Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rigors/chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Allergy/Immunology-Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Inf (clin/microbio) w/Gr 3-4 neuts - Bladder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Inf (clin/microbio) w/Gr 3-4 neuts - Lung

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Inf w/normal ANC or Gr 1-2 neutrophils - Skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Inf w/normal ANC or Gr 1-2 neutrophils - Up airway

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection with unknown ANC - Upper airway NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection-Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** ALT, SGPT (serum glutamic pyruvic transaminase)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** AST, SGOT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Alkaline phosphatase

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Bilirubin (hyperbilirubinemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Creatinine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Leukocytes (total WBC)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neutrophils/granulocytes (ANC/AGC)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Platelets

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Weight gain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Weight loss

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Albumin, serum-low (hypoalbuminemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Calcium, serum-high (hypercalcemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Calcium, serum-low (hypocalcemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Glucose, serum-high (hyperglycemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Glucose, serum-low (hypoglycemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Magnesium, serum-low (hypomagnesemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Potassium, serum-low (hypokalemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Sodium, serum-low (hyponatremia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Muscle weakness, not d/t neuropathy - Extrem-lower

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Muscle weakness, not d/t neuropathy - body/general

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Back

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Bone

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Extremity-limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Joint

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Neck

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Tumor pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neurology-Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neuropathy: motor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neuropathy: sensory

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain - Head/headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Confusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Mood alteration - depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Glomerular filtration rate

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Proteinuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Sexual/Reproductive Function-Other (Specify)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Allergic rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Bronchospasm, wheezing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dyspnea (shortness of breath)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hemorrhage, Respiratory tract NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hemorrhage, pulmonary/upper respiratory - Nose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pulmonary/Upper Respiratory-Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dermatology/Skin-Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rash/desquamation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rash: erythema multiforme

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Skin breakdown/decubitus ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (3.0)

#### Serious Events

**Term:** Edema: limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 7

**Term:** Bilirubin (hyperbilirubinemia)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 7

**Term:** Platelets

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 7

**Term:** Death - Disease progression NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 7

**Term:** Dyspnea (shortness of breath)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 7

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 7

**Units:** Participants

### Group

**ID:** BG000

**Title:** Bortezomib With Thalidomide and Dexamethasone

**Description:** Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 37.6

**Upper Limit:** 81.4

**Value:** 63.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** rorlowsk@mdanderson.org
**Organization:** SWOG
**Phone:** (713) 792-2860
**Title:** Robert Z. Orlowski, MD, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 12
- **Value:** 8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** To evaluate the qualitative and quantitative toxicities associated with this regimen.
**Parameter Type:** NUMBER
**Population Description:** All participants receiving at least one dose of induction therapy
**Reporting Status:** POSTED
**Time Frame:** From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years
**Title:** Toxicity Evaluation
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
**ID:** OG000
**Title:** Bortezomib + Thal/Dex
#### Outcome Measure 2
**Description:** Responses are defined as follows:

Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.

Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein \< 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.

Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.
**Parameter Type:** NUMBER
**Population Description:** Ninety patients is sufficient to distinguish between the null hypothesis that the response rate is 45% versus the alternative of a response rate of 60% with 89% power, using a one-sided test based on the binomial distribution with a significance level of 5%.
**Reporting Status:** POSTED
**Time Frame:** 1 year
**Title:** Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
**ID:** OG000
**Title:** Bortezomib With Thalidomide and Dexamethasone
#### Outcome Measure 3
**Description:** From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.
**Reporting Status:** POSTED
**Time Frame:** about 12-18 months
**Title:** Progression-Free Survival
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
**ID:** OG000
**Title:** Bortezomib With Thalidomide and Dexamethasone
### Participant Flow Module
#### Group
**Description:** Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
**ID:** FG000
**Title:** Bortezomib With Thalidomide and Dexamethasone Induction
#### Period
**Title:** Induction
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
#### Period
**Title:** Maintenance
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
**Has Results:** True