An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice (MIROIR)
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|ClinicalTrials.gov Identifier: NCT02902900|
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : November 15, 2018
This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.
This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice|
|Actual Study Start Date :||September 25, 2015|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2020|
Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice
- Progression Free Survival (PFS) [ Time Frame: Up to approximately 6 months ]Is defined as the time between the date of treatment initiation with pomalidomide and the date of the first progression according to the International Myeloma Working Group (IMWG) criteria or death whatever the cause.
- Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]Is defined by at least a partial response (PR) according to IMWG criteria
- Duration of Response (DOR) [ Time Frame: Up to 2 years ]Is calculated for responders with at least partial response (PR) as the time between the first observation of response and the time of the first event such as disease progression or death due to progression.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.
- Time to Progression (TTP) [ Time Frame: Up to 2 years ]Is defined as the time between the start of pomalidomide treatment and disease progression according to IMWG criteria, or death due to progression.
- Time to Treatment Failure (TTF) [ Time Frame: Up to 2 Years ]Is defined as the duration between the date of the start of pomalidomide treatment and the first progression according to IMWG criteria, second cancer, toxicity requiring treatment discontinuation or death of the patient.
- Adverse Events (AEs) [ Time Frame: Up to 3 years ]Number of subjects 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): NCT02902900
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|Study Director:||Pierre Lauvray||Celgene France|