Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Celgene
- Enrollment
- 2504
- Locations
- 120
- Primary Endpoint
- Progression Free Survival (PFS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patient (age ≥ 18 yrs),
- •Diagnosed with multiple myeloma (measurable or not),
- •In whom pomalidomide treatment was first initiated between October 1, 2014, and September 30, 2019,
- •Patient already included in the Imnovid registry,
- •Having received oral and written information about the study, and having given their consent to participate.
Exclusion Criteria
- •Previous participation in a clinical trial with pomalidomide,
- •Treatment with pomalidomide in a previous line,
- •Simultaneous participation in a clinical trial.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time to Progression (TTP)(Up to 2 years)
- Overall Response Rate (ORR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Time to Treatment Failure (TTF)(Up to 2 Years)
- Adverse Events (AEs)(Up to 3 years)