Study of Carfilzomib with Dexamethasone vs Velcade with Dexamethasone
Research type
Research Study
Full title
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients with Relapsed Multiple Myeloma
IRAS ID
105168
Contact name
Faith Davies
Sponsor organisation
Onyx Pharmaceuticals, Inc.
Eudract number
2012-000128-16
Clinicaltrials.gov Identifier
Research summary
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients with Relapsed Multiple Myeloma. Multiple myeloma is a type of cancer that develops from cells in the bone marrow called plasma cells and affects how normal blood cells grow and work. This is the second most common blood disease and is responsible for approximately 11,000 deaths per year in the United States (US) and more than 19,000 deaths per year in Europe. Multiple myeloma is characterised by anemia (a condition where the blood is deficient in red blood cells), bone destruction, kidney failure, hypercalcemia (the presence of excess calcium in the blood), and an increased susceptibility to infections. Current treatment options for patients with multiple myeloma generally include a combination of chemotherapies. The purpose of this study is to compare progression free survival, or the duration of time before a patient's cancer gets worse, while being treated with two different types of chemotherapy. This study will compare a standard chemotherapy called bortezomib, or Velcade, with an investigational (or not approved for general use) chemotherapy called Carfilzomib. Participants will also receive a steroid called Dexamethasone that prevents the release of chemicals in the body that cause inflammation. The study will be carried out at approximately 200 hospitals with approximately 888 patients that will be invited to participate. Doctors in the Haemato-Oncology Departments of NHS hospitals will be treating participants in the United Kingdom. Eligible patients will be randomly assigned to receive either the study medication (carfilzomib) or a standard chemotherapy called bortezomib. They will have a 50% chance of receiving the carfilzomib. The study will consist of screening, a treatment phase and a follow up phase until the patient's condition worsens or they decide to withdraw from the study. Participation could last up to 2.5 years.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
12/LO/0845
Date of REC Opinion
17 Aug 2012
REC opinion
Further Information Favourable Opinion