Onyx:Study of Carfilzomib in Newly Diagnosed Multiple Myeloma Patients
Research type
Research Study
Full title
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma
IRAS ID
123038
Contact name
Kwee Yong
Contact email
Sponsor organisation
Onyx Therapeutics, Inc.
Eudract number
2012-005283-97
ISRCTN Number
Not provided
Clinicaltrials.gov Identifier
Not provided
Research summary
This is a Phase 3 international study investigating an experimental new drug called carfilzomib in patients with newly diagnosed multiple myeloma, a cancer that affects how your normal blood cells grow and work. The purpose of this study is to compare the effectiveness of combination therapy with an investigational drug called carfilzomib along with melphalan, and prednisone (CMP) versus the combination of bortezomib (Velcade®), melphalan, and prednisone (VMP), which is an approved therapy in patients with newly diagnosed multiple myeloma. Carfilzomib is a type of drug called a proteasome inhibitor. It works by preventing breakdown of abnormal proteins in cells, causing the cells to die. Cancer cells are more sensitive to these effects than normal cells.
Eligible patients will be allocated to groups in a 1:1 ratio at random to receive either one of the two dosing groups (called the “CMP Arm” and “VMP Arm”). Patients will be told which group they are in. Subjects will receive the treatment determined by randomisation for a maximum of nine 6-week treatment cycles. Patients who complete the 9 cycles of study treatment will have disease response assessments every 6 weeks until confirmed progressive disease. Long-term follow-up for survival will occur every 12 weeks for all subjects after their disease progression until a subject has withdrawn consent for further participation, is lost to follow-up, has died, or a total of 400 deaths have occurred, or study closure, whichever is earlier.
Approximately 882 subjects will be enrolled into this study at about 200 centers around the world. All subjects must be at least 18 years old at the time of study entry. It is expected that this study could last up to 5 years. This study is being sponsored by Onyx Therapeutics, Inc.REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/0668
Date of REC Opinion
29 May 2013
REC opinion
Favourable Opinion