A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.

Study Overview
=================
Brief Summary
-----------------
This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care. The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.

Official Title
-----------------
A Non-interventional Post Authorisation Registry of Patients Treated With Pomalidomide for Relapsed and Refractory Multiple Myeloma Who Have Received at Least Two Prior Treatment Regimens, Including Both Lenalidomide and Bortezomib, and Have Demonstrated Disease Progression on the Last Therapy

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: IMNOVID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Understand and voluntarily sign an informed consent form, if applicable, and have never been previously treated with pomalidomide before their inclusion in the Registry. Patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment. Exclusion Criteria: Refusal to participate in the Registry or currently participating in the treatment phase of an interventional clinical trial. Pregnancy. Women of childbearing potential, unless all the conditions of the pregnancy prevention program are met. Male patients unable to follow or comply with the required contraceptive measures. Hypersensitivity to the active substance or to any of the excipients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsed and Refractory Multiple Myeloma Patients<br>Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide) | Drug: IMNOVID<br>* IMNOVID (pomalidomide) as prescribed in routine clinical practice<br>* Other names: BMS-986379;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine incidence of risks as outlined in the Risk Management Plan | To characterize and determine the incidence of important identified and potential risks as outlined in the risk management plan (RMP) among previously treated multiple myeloma patients who are currently being treated with IMNOVID (pomalidomide) in a post-marketing setting. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Prevention Programme Effectiveness | To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry | Up to 3 years | 
| Previous Treatments | To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide). | Approximately 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Imnovid, Pomalidomide, Multiple Myeloma, Relapsed, Refractory, Observational, Registry, Post-approval, Safety