Non-interventional Study With Pomalidomide (Imnovid®)

Study Overview
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Brief Summary
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The purpose of this non-interventional study is to collect data on the efficiency and safety of pomalidomide in combination with dexamethasone in the routine application

Official Title
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Non-interventional Study of Pomalidomide (Imnovid®) in Combination With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Conditions
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Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with relapsed or refractory multiple myeloma Patients must have received at least two prior lines of treatment (induction therapy followed by stem cell transplantation ± maintenance therapy is considered one prior therapy) and must have progressed under the most recent therapy regimen Adult male and female patients (at least 18 years with no upper age limit) Written informed consent to data collection and pseudonymized data transfer The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential (see summary of product characteristics Imnovid®) Other criteria according to summary of product characteristics Imnovid® Exclusion Criteria: Missing patient's informed consent Pregnant or breast-feeding women Male patients, not capable of complying the required preventive measures (see summary of product characteristics Imnovid®) Other criteria according to summary of product characteristics Imnovid®

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 |
| --- | --- |
| Pomalidomide following lenalidomide<br>75 patients with pomalidomide directly following lenalidomide treatment | |
| Pomalidomide following other therapy<br>75 patients with pomalidomide following any other prior therapy. This includes lenalidomide in earlier lines than the most recent line. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) |  | 6 years | 
| Time to Treatment Discontinuation (TTD) |  | 6 years | 
| Time to next treatment (TNT) |  | 6 years | 
| adverse reaction profile |  | 3 years | 
| secondary malignancies | long term safety is focused on secondary malignancies | 6 years | 
| overall Survival (OS) |  | 6 years | 
| relative dose intensity of pomalidomide and dexamethasone |  | 3 years | 
| assess changes in myeloma-related quality of life |  | 3 years | 
| explore additional supportive therapies | To explore additional supportive therapies used on this patient population (e.g. G-CSF, antibiotics, DVT prophylaxis) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,