Companion Study of Pomalidomide in Subjects with Multiple Myeloma

• Research type

  Research Study

• Full title

  Open-label, multi-center, single-arm study for the safety and efficacy of pomalidomide (CC-4047) monotherapy for subjects with refractory or relapsed and refractory multiple myeloma: a companion study for clinical trial CC-4047-MM-003

• IRAS ID

  72915

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-023343-16

• ISRCTN Number

  Not known

• Research summary

  Open-label, multi-center, single-arm study for the safety and efficacy of pomalidomide (CC-4047) monotherapy for participants with refractory or relapsed and refractory multiple myeloma (MM): a companion study for clinical trial CC-4047-MM-003.MM is a rare and incurable type of cancer that affects blood cells found in the bone marrow. The blood cells become damaged and begin to damage the outer casing of bone causing bone pain and weakness. Bones with a high concentration of bone marrow are affected (the spine, skull, pelvis, rib cage, shoulder blades and hip bones).This study will evaluate the effectiveness and safety of an experimental drug, pomalidomide, as a single treatment for patients diagnosed with MM that's unresponsive to treatment (refractory) or has responded to treatment but has since got worse (relapsed).This study will enroll up to 85 participants in the European Union, Switzerland, Russia and Australia in approximately 80 research sites. Eligible participants will have participated in the clinical trial CC-4047-MM-003 on Treatment Arm B (high-dose dexamethasone) and discontinued due to disease progression after at least 2 cycles of treatment. Patients who did not participate in the CC-4047-MM-003 study cannot participate.In the UK, the study will be conducted by doctors in the haematology departments of NHS hospitals.Participants will receive pomalidomide until they develop intolerable toxicity, pass-away, withdraw from participation in the study, withdrawal their consent, or get lost to follow-up. Upon discontinuation from the study treatment, all participants will be followed up by telephone 4 times a year to be assessed for survival and subsequent anti-myeloma regimens. The follow-up calls will continue every 3 months until 5 years after the participant started their treatment or they pass away.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/0081

• Date of REC Opinion

  17 May 2011

• REC opinion

  Further Information Favourable Opinion