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 (CC-4047-MM-015 (ARTIMiDs))

Study identification

• EU PAS number:
  EUPAS7252
• Study ID:
  39569
• Official title and acronym:
  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 (CC-4047-MM-015 (ARTIMiDs))
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Germany

  Italy

  Norway

  Spain

  Sweden

  United Kingdom
• Study description:
  Patients will be recruited from approximately 80 hematology/oncology sites in European countries. In all cases, the decision to treat the patient will be made prior to the decision to enroll the patient into the registry. The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. As the anticipated withdrawal rate before the end of cycle 2 is estimated to be approximately 24% (based on Celgene-sponsored pivotal study CC-4047-MM-003) approximately 750 MM patients will need to be enrolled. Following completion of treatment, patients will be followed up after 30 days and then every 6 months to assess status. 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. Patients will be recruited consecutively. If the reason for discontinuation for patients from the registry is due to an adverse event, the follow up of the adverse event will not be time limited and will continue until resolution or stabilization or when, no additional useful information can be obtained from the event or the patient withdraws consent to anymore data being collected.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Celgene International

See attached document for site list See attached document for site list

Study timelines

Date when funding contract was signed

Actual: 16/11/2013

Study start date

Planned: 01/11/2014

Actual: 26/06/2014

Date of final study report

Planned: 31/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celgene International Sarl

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)