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

NCT02387879 | Unknown

• 1 other identifier: CC-5013-PASS-TR
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 38

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; PASS; Observational; Non-interventional; Relapse; Refractory; CC-5013; Lenalidomide; Turkey

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with Adverse Events

  Up to 5 years

Study Arms (1)

Group 1

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (38)

Baskent University Adana Application and Research Hospital

Adana, 01250, Turkey (Türkiye)

Location

Cukurova University Medical Faculty

Adana, 01330:, Turkey (Türkiye)

Location

Gulhane Military Medical Academy

Ankara, 06010:, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06100:, Turkey (Türkiye)

Location

Ankara Numune Training and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bayindir Hospital

Ankara, 06250, Turkey (Türkiye)

Location

Baskent University Ankara Hospital

Ankara, 06490, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

Location

Antalya Medstar Hospital

Antalya, 07030, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, 07070:, Turkey (Türkiye)

Location

Ali Osman Sonmez Oncology Hospital

Bursa, 16040, Turkey (Türkiye)

Location

Uludag University Medical Faculty

Bursa, 16059, Turkey (Türkiye)

Location

Pamukkale University Medical Faculty

Denizli, 20070, Turkey (Türkiye)

Location

Dicle University Medical Faculty

Diyarbakır, 21280:, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Osmangazi University Medical Faculty

Eskişehir, 26480, Turkey (Türkiye)

Location

Gaziantep University Medical Faculty

Gaziantep, 27310, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Kartal Training and Research Hospital

Istanbul, 34865, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research

Istanbul, 34890:, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty

Izmir, 35340:, Turkey (Türkiye)

Location

Izmir Medical Park Hospital

Izmir, 35575, Turkey (Türkiye)

Location

Erciyes University Medical Faculty

Kayseri, 38039, Turkey (Türkiye)

Location

Kocaeli University Medical Faculty

Kocaeli, 41380, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty

Konya, 42090, Turkey (Türkiye)

Location

Inonu University Medical Faculty

Malatya, 44280, Turkey (Türkiye)

Location

Celal Bayar University Medical Faculty

Manisa, 45030, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, 33343:, Turkey (Türkiye)

Location

Ondokuz Mayis University Medical Faculty

Samsun, 55139, Turkey (Türkiye)

Location

Namik Kemal University Medical Faculty

Tekirdağ, 59100, Turkey (Türkiye)

Location

Karadeniz Technical University Medical Faculty

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret Atiba-Davies, PhD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: March 13, 2015
• Study Start: December 25, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

TU (38)