An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice

Study Overview
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Brief Summary
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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.

Official Title
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Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice

Conditions
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Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Imnovid<br>Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Is defined by at least a partial response (PR) according to IMWG criteria | 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. | 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. | 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. | 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. | Up to 2 Years | 
| Adverse Events (AEs) | Number of subjects with adverse events | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Pomalidomide, Efficacy