Carfilzomib for Advanced Refractory Multiple Myeloma European Study
Research type
Research Study
Full title
A Randomized, Open-label, Phase 3 Study of Carfilzomib vs Best Supportive Care in Subjects with Relapsed and Refractory Multiple Myeloma
IRAS ID
86499
Contact name
Kwee Yong
Sponsor organisation
Onyx Therapeutics, Inc.
Eudract number
2009-016840-38
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3 international study investigating an experimental new drug called carfilzomib in patients with multiple myeloma, a common hematologic malignancy. The purpose of this study is to evaluate the safety and effectiveness of carfilzomib in patients with multiple myeloma, who have no available, approved, alternative therapies and who would otherwise be offered supportive care that does not affect the cause of disease. Carfilzomib is a type of drug called a proteasome inhibitor. Proteasome inhibitors block the action of proteasomes. Proteasomes are found inside normal and tumor cells, and have the important role of identifying and marking damaged proteins so they can be broken down. By blocking the action of proteasomes, damaged protein will accumulate within the tumor cells and cause them to die. Eligible patients will be allocated to groups in a 1:1 ratio at random to receive either carfilzomib by intravenous infusion or best supportive care. Best supportive care includes taking prednisolone orally or dexamethasone orally (or a similar drug that reduces inflammation) plus other supportive measures that investigators consider to be the best supportive care (this may include a low dose of a chemotherapy drug cyclophosphamide). Patients will receive their initial study treatment (in 28-day cycles) until disease progression confirmed by different laboratory tests or unacceptable side effects (whichever occurs first). Patients will be followed for 30 additional days to ensure there are no side effects and will enter long term follow-up period. All patients will continue to be followed until death, unless consent has been withdrawn for further participation, the patient becomes lost to follow-up, or the Sponsor makes a decision to close the study.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
11/SC/0479
Date of REC Opinion
22 Nov 2011
REC opinion
Favourable Opinion