Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02741544|
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : February 5, 2019
To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.
- 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 is reached.
- Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||578 participants|
|Official Title:||Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])|
|Actual Study Start Date :||March 3, 2016|
|Estimated Primary Completion Date :||August 21, 2021|
|Estimated Study Completion Date :||August 21, 2021|
Patients with newly-diagnosed multiple myeloma (NDMM)
Patients with newly-diagnosed multiple myeloma (NDMM) who are treated with Revlimid Capsules (Revlimid)
- Adverse Events (AEs) [ Time Frame: Up to approximately 6 months ]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): NCT02741544
|Kobe, Hyogo, Japan, 651-0072|
|Study Director:||Jinshu Cho, Celgene Study Director||Celgene|