Carfilzomib in patients with Relapsed Multiple Myeloma
Research type
Research Study
Full title
A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma
IRAS ID
47814
Contact name
Faith Davies
Eudract number
2009-016839-35
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma is a cancer of the bone marrow. It is characterised by bone destruction, kidney failure, an increased chance of catching infections, a decrease in red blood cells and an increase in calcium and a protein called M protein in the blood. It is responsible for more than 19,000 deaths per year in Europe. Current treatments involve combination chemotherapy with or without steroids. Proteasome inhibitors (drugs that block the action of large proteins that help to destroy other proteins in the cell) and immunomodulators (drugs that affect the immune system) are highly effective. Lenalidomide is an immunomodulator and studies have shown that it makes multiple myeloma more sensitive to a proteasome inhibitor called bortezomib. This suggests a combination therapy may be beneficial. Carfilzomib is a proteasome inhibitor that has been well tolerated in previous studies which makes it a promising drug to combine with lenalidomide. The purpose of the study is to look at progression-free survival (the length of time during and after treatment when multiple myeloma does not get worse) in patients receiving carfilzomib, lenalidomide and dexamethasone (CRd) compared to patients receiving lenalidomide and dexamethasone alone (Rd). Patients will be allocated in a 1:1 ratio to receive either CRd or Rd. Each cycle lasts 28 days. Patients in the CRd group will receive carfilzomib on Days 1, 2, 8, 9, 15 and 16 up to Cycle 12 and on Days 1, 2, 15 and 16 during Cycles 13 to 18. All patients will receive dexamethasone on Days 1, 8, 15 and 22 and lenalidomide on Days 1-21. Other study procedures that will be performed during clinic visits include physical exam, measurement of vital signs, ECG, blood and urine samples and completion of questionnaires. This study is sponsored by Onyx Pharmaceuticals, Inc. Approximately 700 patients will be enrolled worldwide.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
10/H0806/71
Date of REC Opinion
16 Nov 2010
REC opinion
Further Information Favourable Opinion