C16010: Phase 3 study of MLN9708 in Multiple Myeloma
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
IRAS ID
106389
Contact name
Jamie Cavenagh
Sponsor organisation
Millennium Pharmaceuticals, Inc.
Eudract number
2011-005496-17
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma (MM) is a blood cancer arising from plasma cells, which are found in the bone marrow of your bones. Normal plasma cells help fight infection. In myeloma, the plasma cells are abnormal, grow uncontrolled, act like tumours inside the bones, and no longer do anything useful. In the UK, 10-15,000 patients have MM at any time. It is the commonest form of blood cancer. MM can be treated but not cured. Most treated patients eventually experience a relapse, and for some patients, none of the currently available therapies slow or stop the cancer. Many new drugs such as VELCADE and lenalidomide have improved outcomes and contribute to the chance of being alive 5 years after diagnosis but there is a need for better medicines. MLN9708 is a new experimental medicine, similar to VELCADE. This trial will study the safety and effectiveness of MLN9708 compared to placebo (a dummy drug) in patients with relapsed and/or refractory MM receiving standard lenalidomide and dexamethasone. Treatment will be given in 28-day cycles. MLN9708/placebo capsules will be taken orally on Days 1, 8, and 15; lenalidomide on Days 1 to 21 and dexamethasone on Days 1, 8, 15, and 22 of each cycle. Study visits will be twice per cycle for 3 cycles, then once per cycle for the remainder of the study. Patients may remain on treatment until relapse or unacceptable side effects. After relapse, patients will be contacted every 12 weeks. Overall, from the first patient treated to the last patient stopping treatment, the study could last 81 months. Visit procedures will include physical examinations, blood tests, bone marrow tests and questionnaires about how you are doing and maybe MRI, CT or PET scans. Millennium Pharmaceuticals Inc. is sponsoring this trial where 703 patients will take part from 150 sites worldwide.
REC name
London - City & East Research Ethics Committee
REC reference
12/LO/0949
Date of REC Opinion
15 Sep 2012
REC opinion
Further Information Favourable Opinion