Study of Pomalidomide in Subjects with Multiple Myeloma

• Research type

  Research Study

• Full title

  A Phase 3, Multicentre, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination with Low-Dose Dexamethasone versus High-Dose Dexamethasone in Subjects with Refractory or Relapsed and Refractory Multiple Myeloma

• IRAS ID

  71672

• Contact name

  Stephen Schey

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-019820-30

• ISRCTN Number

  No number provided

• Research summary

  A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination with Low-Dose Dexamethasone versus High-Dose Dexamethasone in Subjects with Refractory or Relapsed and Refractory Multiple Myeloma (MM). 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 compare the effectiveness and safety of an experimental drug, pomalidomide, plus a low-dose steroid (dexamethasone) against high-dose dexamethasone in treating patients with refractory (not responding to treatment) or relapsed (responded to treatment but condition has since got worse) and refractory MM.This study will enroll 426 participants in the European Union, Switzerland, Russia and Australia. Eligible participants will be randomly assigned in a 2:1 ration into one of two treatment arms: A) pomalidomide plus low-dose dexamethasone (approximately 284 participants) or; B) high-dose dexamethasone (approximately 142 participants).In the UK, the study will be conducted by doctors in the haematology departments of NHS hospitals.Participants will be on their assigned study treatment until they experience disease progression, intolerable toxicity, withdraw their participation from the study, become lost to follow-up or pass away. Following discontinuation, participants will be contacted (if applicable) by telephone 4 times a year to discuss their health and anti-myeloma therapies. This will continue for up to 5 years from the date they were randomised. Participants assigned to high-dose dexamethasone who are discontinued due to independent confirmation of disease progression may be referred to a companion study if the investigator believes it is the best treatment option. This is a single-arm study where participants will receive pomalidome only.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/0082

• Date of REC Opinion

  17 May 2011

• REC opinion

  Further Information Favourable Opinion