An observational study in Multiple Myeloma, sponsored by Celgene. Completed at 126 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by Celgene · Observational
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 744 are open to participants now.
This study's enrollment of 2,504 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
The MIROIR study focuses on multiple myeloma patients treated with pomalidomide in France whose treatment was initiated between October 1, 2014, and September 30, 2019. Patients having initiated pomalidomide outside of this period or having received pomalidomide in a previous treatment line will not be included.
Exclusion Criteria:
Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice
Progression Free Survival (PFS)
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.
Time frame: Up to approximately 6 months
Overall Response Rate (ORR)
Is defined by at least a partial response (PR) according to IMWG criteria
Time frame: Up to 2 years
Duration of Response (DOR)
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.
Time frame: Up to 2 years
Overall Survival (OS)
Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.
Time frame: Up to 2 years
Time to Progression (TTP)
Is defined as the time between the start of pomalidomide treatment and disease progression according to IMWG criteria, or death due to progression.
Time frame: Up to 2 years
Time to Treatment Failure (TTF)
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.
Time frame: Up to 2 Years
Adverse Events (AEs)
Number of subjects with adverse events
Time frame: Up to 3 years
Showing the first 100 of 126 sites.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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