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

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ClinicalTrials.gov Identifier: NCT02387879
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Condition or disease
Multiple Myeloma

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 498 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional, Multi-center, Observational Post Authorization Safety Study of Patients With Relapse/Refractory Multiple Myeloma Treated With Lenalidomide in Turkey
Actual Study Start Date : December 25, 2013
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
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




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to 5 years ]
    Number of participants with Adverse Events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387879


Locations
Turkey
Baskent University Adana Application and Research Hospital
Adana, Turkey, 01250
Cukurova University Medical Faculty
Adana, Turkey, 01330:
Gulhane Military Medical Academy
Ankara, Turkey, 06010:
Ankara University Medical Faculty
Ankara, Turkey, 06100:
Ankara Numune Training and Research Hospital
Ankara, Turkey, 06100
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, Turkey, 06110
Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital
Ankara, Turkey, 06200
Hacettepe University Medical Faculty
Ankara, Turkey, 06230
Ankara Bayindir Hospital
Ankara, Turkey, 06250
Baskent University Ankara Hospital
Ankara, Turkey, 06490
Gazi University Medical Faculty
Ankara, Turkey, 06560
Antalya Medstar Hospital
Antalya, Turkey, 07030
Akdeniz University Medical Faculty
Antalya, Turkey, 07070:
Ali Osman Sonmez Oncology Hospital
Bursa, Turkey, 16040
Uludag University Medical Faculty
Bursa, Turkey, 16059
Pamukkale University Medical Faculty
Denizli, Turkey, 20070
Dicle University Medical Faculty
Diyarbakir, Turkey, 21280:
Trakya University Medical Faculty
Edirne, Turkey, 22030
Osmangazi University Medical Faculty
Eskisehir, Turkey, 26480
Gaziantep University Medical Faculty
Gaziantep, Turkey, 27310
Istanbul University Istanbul Medical Faculty
Istanbul, Turkey, 34093
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34098
Bakırkoy Dr.Sadi Konuk Training and Research Hospital
Istanbul, Turkey, 34147
Medipol University Medical Faculty
Istanbul, Turkey, 34214
Kartal Training and Research Hospital
Istanbul, Turkey, 34865
Marmara University Pendik Training and Research
Istanbul, Turkey, 34890:
Ege University Medical Faculty
Izmir, Turkey, 35100
Dokuz Eylul University Medical Faculty
Izmir, Turkey, 35340:
Izmir Medical Park Hospital
Izmir, Turkey, 35575
Erciyes University Medical Faculty
Kayseri, Turkey, 38039
Kocaeli University Medical Faculty
Kocaeli, Turkey, 41380
Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey, 42090
Inonu University Medical Faculty
Malatya, Turkey, 44280
Celal Bayar University Medical Faculty
Manisa, Turkey, 45030
Mersin University Medical Faculty
Mersin, Turkey, 33343:
Ondokuz Mayis University Medical Faculty
Samsun, Turkey, 55139
Namik Kemal University Medical Faculty
Tekirdag, Turkey, 59100
Karadeniz Technical University Medical Faculty
Trabzon, Turkey, 61080
Sponsors and Collaborators
Celgene
Investigators
Study Director: Nadir Ulu, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02387879     History of Changes
Other Study ID Numbers: CC-5013-PASS-TR
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Keywords provided by Celgene:
Multiple Myeloma
PASS
Observational
Non-interventional
Relapse
Refractory
CC-5013
Lenalidomide
Turkey

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents