## Protocol Section
### Identification Module
**NCT ID:** NCT02387879

**Brief Title:** A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR

**Official Title:** A Non-interventional, Multi-center, Observational Post Authorization Safety Study of Patients With Relapse/Refractory Multiple Myeloma Treated With Lenalidomide in Turkey

#### Organization Study ID Info
**ID:** CC-5013-PASS-TR
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
### Status Module
#### Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2019-09-26

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-25

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-12-25

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2015-03-13
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-05
**Study First Submit QC Date:** 2015-03-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Celgene

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in Turkey.

The study is anticipated to last for approximately 8 years. Recruitment period will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide.

**Detailed Description:** Objectives:

- Primary: To characterize and determine the incidence of adverse events of special interest; in subjects treated with Lenalidomide in real life setting in given indication.

- Secondary:

1. To observe the basic adverse event management approaches of physicians
2. To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the prescription line.
3. To monitor the reasons of patients' noncompliance with lenalidomide usage recommended in Patient Information Leaflet.

Subjects will be recruited from approximately 36 hematology/oncology sites in Turkey. In all cases, the decision to treat the patient will be made prior to the decision to enter the subject into the study. All subjects enrolled will be prospectively followed up for up to 36 months, where feasible, following the end of observed treatment period. This 36 month observation period will start from end of treatment. The observation follow up period will end 36 months after the end of lenalidomide or background observed treatment period, or at time of death, withdrawal of consent, or loss to follow up. Following completion of treatment, subjects will be followed up after 30 days and then every 6 months to assess status.

Patients who are eligible and signed a consent form will be recruited consecutively. Subjects who temporarily discontinue treatment for any reason for more than 30 days will be withdrawn from treatment observation but will be observed for safety for up to 36 months (from the end of treatment). If the reason for discontinuation for subjects is due to an adverse event, the follow up of the adverse event will not be time limited and will continue until resolution or stabilization or when, in the opinion of the investigator, no additional useful information can be obtained from the event or the subject withdraws their consent to any more data being collected. Subjects will discontinue from the study if they switch to another treatment. No intervention will be performed to physician. Treatment will be according to physician's regular clinical practice.

All treatments will be prescribed by the treating investigator in accordance with regular clinical practice.

All assessments will be made according to the regular clinical practice of the treating investigator. Therefore if a parameter is requested on the case report form (CRF) but the investigator's normal practice is not to carry out such an assessment, then the field will not be completed.

Statistical Analysis:

Data from all subjects who receive at least one dose of treatment will be included in the safety analysis.

Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE V. 4.03 whenever possible.

Adverse event frequency will be tabulated by body system and MedDRA term. In the by subject analysis, a subject having the same event more than once will be counted only once. Adverse events will be summarized by worst NCI CTCAE V. 4.03 grade.

Adverse events leading to death or to discontinuation from treatment, study-drug-related events, and serious adverse events will be listed separately.

The Kaplan-Meier procedures will be used to characterize time to onset and time to resolution for adverse events of special interest. Multivariate logistic regression will be used to determine the demographic and baseline characteristics most predictive of developing adverse events of interest. A forward selection stepwise procedure will be used to identify the subset of relevant factors.

Summary tables will also be provided for clinically relevant subgroups. Analyses will be undertaken to explore the course of neuropathy for subjects who have pre-existing neuropathy at baseline. Specifically, cross-tabulations will be used to summarize changes in severity observed during lenalidomide treatment and summary statistics will be provided for other relevant variables.

### Conditions Module

**Conditions:**

- Multiple Myeloma

**Keywords:**

- Multiple Myeloma

- PASS

- Observational

- Non-interventional

- Relapse

- Refractory

- CC-5013

- Lenalidomide

- Turkey

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects should be chosen among relapse/refractory multiple myeloma patients who have received at least one prior antimyeloma chemotherapy regimen (excluding treatment regimens with steroid only) with adequate dose and duration (≥2 cycles) or who have relapse/refractory multiple myeloma after stem cell transplantation.

Patients who are eligible for the study will be consecutively enrolled in the study until the targeted patient number is reached. The responsible investigator will be requested to keep a log of subjects who are invited to enter the study. In the case of any of these subjects will not be enrolled in the study, this information will be documented together with its reason

**Label:** Group 1

### Outcomes Module

#### Primary Outcomes

**Description:** Number of participants with Adverse Events

**Measure:** Adverse Events (AEs)

**Time Frame:** Up to 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female multiple myeloma patients with ≥18 years of age.
* Subjects who understand and voluntarily sign an informed consent
* Subjects who are receiving lenalidomide treatment in combination with dexamethasone not longer than four weeks.

Exclusion Criteria:

* - Refusal to participate in the study.
* Patients who are currently on an interventional clinical trial
* Subjects who previously received lenalidomide treatment and whose treatment is ceased or who had a treatment interruption for four weeks or longer.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** It will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide. As a condition of market authorization, subjects should be chosen among relapsed/refractory multiple myeloma patients who have received at least one prior antimyeloma chemotherapy regimen (excluding treatment regimens with steroid only) with adequate dose and duration (≥2 cycles) or who have relapsed/refractory multiple myeloma after stem cell transplantation. Patients who are eligible for the study will be consecutively enrolled in the study until the targeted patient number is reached. The responsible investigator will be requested to keep a log of subjects who are invited to enter the study. In the case of any of these subjects will not be enrolled in the study, this information will be documented together with its reason.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Adana

**Country:** Turkey

**Facility:** Baskent University Adana Application and Research Hospital

**Zip:** 01250

**Location 2:**

**City:** Adana

**Country:** Turkey

**Facility:** Cukurova University Medical Faculty

**Zip:** 01330:

**Location 3:**

**City:** Ankara

**Country:** Turkey

**Facility:** Gulhane Military Medical Academy

**Zip:** 06010:

**Location 4:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara University Medical Faculty

**Zip:** 06100:

**Location 5:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara Numune Training and Research Hospital

**Zip:** 06100

**Location 6:**

**City:** Ankara

**Country:** Turkey

**Facility:** Diskapi Yildirim Beyazit Training and Research Hospital

**Zip:** 06110

**Location 7:**

**City:** Ankara

**Country:** Turkey

**Facility:** Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital

**Zip:** 06200

**Location 8:**

**City:** Ankara

**Country:** Turkey

**Facility:** Hacettepe University Medical Faculty

**Zip:** 06230

**Location 9:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara Bayindir Hospital

**Zip:** 06250

**Location 10:**

**City:** Ankara

**Country:** Turkey

**Facility:** Baskent University Ankara Hospital

**Zip:** 06490

**Location 11:**

**City:** Ankara

**Country:** Turkey

**Facility:** Gazi University Medical Faculty

**Zip:** 06560

**Location 12:**

**City:** Antalya

**Country:** Turkey

**Facility:** Antalya Medstar Hospital

**Zip:** 07030

**Location 13:**

**City:** Antalya

**Country:** Turkey

**Facility:** Akdeniz University Medical Faculty

**Zip:** 07070:

**Location 14:**

**City:** Bursa

**Country:** Turkey

**Facility:** Ali Osman Sonmez Oncology Hospital

**Zip:** 16040

**Location 15:**

**City:** Bursa

**Country:** Turkey

**Facility:** Uludag University Medical Faculty

**Zip:** 16059

**Location 16:**

**City:** Denizli

**Country:** Turkey

**Facility:** Pamukkale University Medical Faculty

**Zip:** 20070

**Location 17:**

**City:** Diyarbakir

**Country:** Turkey

**Facility:** Dicle University Medical Faculty

**Zip:** 21280:

**Location 18:**

**City:** Edirne

**Country:** Turkey

**Facility:** Trakya University Medical Faculty

**Zip:** 22030

**Location 19:**

**City:** Eskisehir

**Country:** Turkey

**Facility:** Osmangazi University Medical Faculty

**Zip:** 26480

**Location 20:**

**City:** Gaziantep

**Country:** Turkey

**Facility:** Gaziantep University Medical Faculty

**Zip:** 27310

**Location 21:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Istanbul University Istanbul Medical Faculty

**Zip:** 34093

**Location 22:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Istanbul University Cerrahpasa Medical Faculty

**Zip:** 34098

**Location 23:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Bakırkoy Dr.Sadi Konuk Training and Research Hospital

**Zip:** 34147

**Location 24:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Medipol University Medical Faculty

**Zip:** 34214

**Location 25:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Kartal Training and Research Hospital

**Zip:** 34865

**Location 26:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Marmara University Pendik Training and Research

**Zip:** 34890:

**Location 27:**

**City:** Izmir

**Country:** Turkey

**Facility:** Ege University Medical Faculty

**Zip:** 35100

**Location 28:**

**City:** Izmir

**Country:** Turkey

**Facility:** Dokuz Eylul University Medical Faculty

**Zip:** 35340:

**Location 29:**

**City:** Izmir

**Country:** Turkey

**Facility:** Izmir Medical Park Hospital

**Zip:** 35575

**Location 30:**

**City:** Kayseri

**Country:** Turkey

**Facility:** Erciyes University Medical Faculty

**Zip:** 38039

**Location 31:**

**City:** Kocaeli

**Country:** Turkey

**Facility:** Kocaeli University Medical Faculty

**Zip:** 41380

**Location 32:**

**City:** Konya

**Country:** Turkey

**Facility:** Necmettin Erbakan University Meram Medical Faculty

**Zip:** 42090

**Location 33:**

**City:** Malatya

**Country:** Turkey

**Facility:** Inonu University Medical Faculty

**Zip:** 44280

**Location 34:**

**City:** Manisa

**Country:** Turkey

**Facility:** Celal Bayar University Medical Faculty

**Zip:** 45030

**Location 35:**

**City:** Mersin

**Country:** Turkey

**Facility:** Mersin University Medical Faculty

**Zip:** 33343:

**Location 36:**

**City:** Samsun

**Country:** Turkey

**Facility:** Ondokuz Mayis University Medical Faculty

**Zip:** 55139

**Location 37:**

**City:** Tekirdag

**Country:** Turkey

**Facility:** Namik Kemal University Medical Faculty

**Zip:** 59100

**Location 38:**

**City:** Trabzon

**Country:** Turkey

**Facility:** Karadeniz Technical University Medical Faculty

**Zip:** 61080

#### Overall Officials

**Official 1:**

**Affiliation:** Celgene

**Name:** Margaret Atiba-Davies, PhD

**Role:** STUDY_DIRECTOR

## 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 - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1725

- Name: Lenalidomide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
