A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
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|ClinicalTrials.gov Identifier: NCT02164955|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : July 17, 2019
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 up prospectively for up to 3 years following the end of pomalidomide treatment. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: IMNOVID|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||775 participants|
|Target Follow-Up Duration:||5 Years|
|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|
|Actual Study Start Date :||June 26, 2014|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
Relapsed and Refractory Multiple Myeloma Patients
Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
IMNOVID (pomalidomide) as prescribed in routine clinical practice
Other Name: pomalidomide
- Determine incidence of risks as outlined in the Risk Management Plan [ Time Frame: Up to 5 years ]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.
- Pregnancy Prevention Programme Effectiveness [ Time Frame: Up to 5 years ]To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry
- Previous Treatments [ Time Frame: Approximately 6 months ]To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164955
|Study Director:||Elisabeth Kueenburg, MD||Celgene|