A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use
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|ClinicalTrials.gov Identifier: NCT02922543|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : May 22, 2020
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.
- Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths).
- Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||361 participants|
|Official Title:||Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use|
|Actual Study Start Date :||February 18, 2011|
|Estimated Primary Completion Date :||June 19, 2020|
|Estimated Study Completion Date :||June 19, 2020|
Relapsed or refractory multiple myeloma (MM) patients
Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.
- Adverse Events (AEs) [ Time Frame: 3 years ]Number of participants with adverse events
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): NCT02922543
|Kobe, Hyogo, Japan, 651-0072|
|Study Director:||Jinshu Cho||Celgene|