## Protocol Section
### Identification Module
**NCT ID:** NCT02703779

**Brief Title:** Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)

**Official Title:** An Exploratory Trial to Estimate the Proportion of Patients With Tumor Cell Contaminated, Flow Positive Leukapheresis Products Collected With and Without Bortezomib as In-vivo Purging Prior to Autologous Stem Cell Harvest for Multiple Myeloma

#### Organization Study ID Info
**ID:** 2015-IIT-BMT-MM-AutoSCT
#### Organization
**Class:** OTHER
**Full Name:** University of Kansas Medical Center
### Status Module
#### Completion Date
**Date:** 2020-04-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-06-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-10-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-06-18

**Type:** ACTUAL

**Results First Submit Date:** 2021-04-29

**Results First Submit QC Date:** 2021-05-24

#### Start Date
**Date:** 2016-03

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2016-03-09
**Type:** ESTIMATED
**Study First Submit Date:** 2016-02-18
**Study First Submit QC Date:** 2016-03-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Siddhartha Ganguly

#### Responsible Party

**Investigator Affiliation:** University of Kansas Medical Center

**Investigator Full Name:** Siddhartha Ganguly

**Investigator Title:** Medical Doctor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.

**Detailed Description:** High dose chemotherapy with autologous stem cell transplant has resulted in improved overall survival and is currently considered an effective first line therapy applicable to the majority of patients with multiple myeloma. However disease relapse is inevitable and remains the primary cause of mortality in this cohort.

The purpose of this study is to estimate the proportion of subjects with plasma cell contamination of harvested stem cell product in standard and treatment arms. The study will explore whether or not in-vivo purging of malignant tumor plasma cells will improve progression free survival (PFS) for patients.

The study will consist of two groups:

Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib. Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed.

Group B: Bortezomib 1.3mg/m\^2 will be given subcutaneously (SQ) on days -11 and -8 followed by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell harvest (day 0).

### Conditions Module

**Conditions:**

- Multiple Myeloma

**Keywords:**

- Multiple Myeloma

- Bortezomib

- Autologous

- Stem Cell

- Purging

- In-vivo purging

- Ex-vivo purging

- Leukapheresis

- Contaminated

- Stem Cell Harvest

- Stem Cell Transplant

- Transplantation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 101

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

**Intervention Names:**

- Drug: Granulocyte colony-stimulating factor (G-CSF)

- Drug: Mozobil

**Label:** Stem cell collection without in-vivo purging with Bortezomib

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

**Intervention Names:**

- Drug: Bortezomib

- Drug: Granulocyte colony-stimulating factor (G-CSF)

- Drug: Mozobil

**Label:** Stem cell collection with in-vivo purging with Bortezomib

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Stem cell collection with in-vivo purging with Bortezomib

**Description:** Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

**Name:** Bortezomib

**Other Names:**

- VELCADE

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Stem cell collection with in-vivo purging with Bortezomib

- Stem cell collection without in-vivo purging with Bortezomib

**Description:** Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

**Name:** Granulocyte colony-stimulating factor (G-CSF)

**Other Names:**

- NEUPOGEN

- filgrastim

- filgrastim-sndz

- Zarxio

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Stem cell collection with in-vivo purging with Bortezomib

- Stem cell collection without in-vivo purging with Bortezomib

**Description:** Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

**Name:** Mozobil

**Other Names:**

- plerixafor

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Estimate the proportion of subjects with plasma cell contamination (defined as \>0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil.

**Measure:** Multiparametric Flow Cytometry - Minimum Residual Disease

**Time Frame:** Day 0 for all subjects (Day 0 is the day of stem cell collection)

#### Secondary Outcomes

**Description:** Estimate the proportion of subjects who have a successful collection of stem cells (\> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups.

**Measure:** Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment

**Time Frame:** Within the first 30 days after stem cell collection

**Description:** Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection.

**Measure:** Cluster of Differentiation 34 (CD34) Enumeration

**Time Frame:** Within the first 30 days after stem cell collection

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects must meet all of the inclusion criteria to participate in this study.
* Ability to understand, and the willingness to sign a written Informed Consent Form
* Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation
* Age ≥ 18 years
* Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
* Adequate organ and marrow function as defined below:

  * leukocytes ≥ 3,000/micro Liter (mcL)
  * absolute neutrophil count ≥ 1,500/mcL
  * platelets ≥ 100,000/mcL
  * total bilirubin within normal institutional limits NOTE: For this study, subjects with bilirubin levels \> 1.5 Upper Limit of Normal (ULN) are excluded from enrollment in this study.
  * Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase \[SGOT\]) ≤ 2.5 X institutional upper limit of normal
  * Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase \[SPGT\]) ≤ 2.5 X institutional upper limit of normal
  * creatinine within normal institutional limits
* Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  * Has not undergone a hysterectomy or bilateral oophorectomy; or
  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria:

* Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
* Current or anticipated use of other investigational agents. NOTE the following clarification for this study: Prohibited Concurrent Therapy:

Participation in clinical trials with other investigational agents that are not included in this trial, within 14 days of the start of this trial until 2 weeks after participant has received the last dose of bortezomib for mobilization.

* Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating factor (G-CSF)
* Subject has received \> 6 months of lenalidomide (Revlimid®) therapy prior to stem cell collection
* Subject has known brain metastases. Presence of brain metastases should be excluded from this clinical trial because of poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Grade 3 or higher peripheral neuropathy
* Bilirubin levels \> 1.5 ULN
* Uncontrolled inter-current illness including, but not limited to

  * ongoing or active infection
  * symptomatic congestive heart failure
  * unstable angina pectoris
  * cardiac arrhythmia
  * psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing: There is a potential for congenital abnormalities and for this regimen to harm nursing infants.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Westwood

**Country:** United States

**Facility:** The University of Kansas Medical Center

**State:** Kansas

**Zip:** 66205

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Kansas - Cancer Center

**Name:** Siddhartha Ganguly, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omede P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE; European Myeloma Network. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica. 2008 Mar;93(3):431-8. doi: 10.3324/haematol.11080. Epub 2008 Feb 11.

**PMID:** 18268286

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-11-21

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 7919295

- Type Abbrev: Prot_SAP

- Upload Date: 2021-04-27T15:36

- Date: 2019-05-28

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 262326

- Type Abbrev: ICF

- Upload Date: 2021-04-27T15:35

## 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: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M340828

- Name: Plerixafor

- Relevance: HIGH

- As Found: Autonomic

- ID: M1945

- Name: Lenograstim

- Relevance: HIGH

- As Found: 30 minutes

- ID: M376

- Name: Bortezomib

- Relevance: HIGH

- As Found: 14 days

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000088327

- Term: Plerixafor

- ID: D000069286

- Term: Bortezomib

- ID: D000078224

- Term: Lenograstim

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 51

**Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

**ID:** EG000

**Other Num Affected:** 39

**Other Num at Risk:** 51

**Serious Number Affected:** 12

**Serious Number At Risk:** 51

**Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib

**Group ID:** EG001

**Title:** Stem Cell Collection With In-vivo Purging With Bortezomib

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 50

**Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

**ID:** EG001

**Other Num Affected:** 39

**Other Num at Risk:** 50

**Serious Number Affected:** 24

**Serious Number At Risk:** 50

**Title:** Stem Cell Collection With In-vivo Purging With Bortezomib

**Frequency Threshold:** 5

#### Other Events

**Term:** Anemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dyspnea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Edema limbs

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Generalized muscle weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** 

**Term:** Hypokalemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hypomagnesemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hyponatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Mucositis oral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** White blood cell decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

#### Serious Events

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 51

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 50

**Num Events:** 7

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 51

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 50

**Num Events:** 2

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 51

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Term:** Enterocolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 51

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 50

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 51

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 50

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Term:** Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 50

**Num Events:** 2

**Term:** Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Term:** Mucositis oral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 50

**Num Events:** 4

**Term:** Peripheral sensory neuropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 51

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 50

**Num Events:** 2

**Time Frame:** From the time of signing the consent until 30 days after collection or up to 2 months.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 51

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 101

**Units:** Participants

### Group

**ID:** BG000

**Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib

**Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

### Group

**ID:** BG001

**Title:** Stem Cell Collection With In-vivo Purging With Bortezomib

**Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 37

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 66

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 35

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 42

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 59

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 49

#### Measurement

**Group ID:** BG001

**Value:** 46

#### Measurement

**Group ID:** BG002

**Value:** 95

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** sganguly@kumc.edu
**Organization:** University of Kansas Cancer Center
**Phone:** 913-588-6030
**Title:** Dr. Sid Ganguly
## 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:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.1
- **Upper Limit:** 
- **Value:** 8.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.1
- **Upper Limit:** 
- **Value:** 7.8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Estimate the proportion of subjects with plasma cell contamination (defined as \>0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Day 0 for all subjects (Day 0 is the day of stem cell collection)
**Title:** Multiparametric Flow Cytometry - Minimum Residual Disease
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** OG000
**Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib
##### Group
**Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** OG001
**Title:** Stem Cell Collection With In-vivo Purging With Bortezomib
#### Outcome Measure 2
**Description:** Estimate the proportion of subjects who have a successful collection of stem cells (\> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Within the first 30 days after stem cell collection
**Title:** Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** OG000
**Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib
##### Group
**Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** OG001
**Title:** Stem Cell Collection With In-vivo Purging With Bortezomib
#### Outcome Measure 3
**Description:** Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Within the first 30 days after stem cell collection
**Title:** Cluster of Differentiation 34 (CD34) Enumeration
**Type:** SECONDARY
**Unit of Measure:** percentage of CD34 positive cells
##### Group
**Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** OG000
**Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib
##### Group
**Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** OG001
**Title:** Stem Cell Collection With In-vivo Purging With Bortezomib
### Participant Flow Module
#### Group
**Description:** Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** FG000
**Title:** Stem Cell Collection Without In-vivo Purging With Bortezomib
#### Group
**Description:** Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
**ID:** FG001
**Title:** Stem Cell Collection With In-vivo Purging With Bortezomib
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 51
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 51
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 50
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True