MLN9708 in Multiple Myeloma after Autologous Stem Cell Transplant
Research type
Research Study
Full title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
IRAS ID
146391
Contact name
Martin Kaiser
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc.
Eudract number
2013-002076-41
Research summary
The sponsor, Millennium has developed an investigational drug called ixazomib citrate (MLN9708) which is currently being studied in patients with multiple myeloma, a cancer of the bone marrow, either as a single agent or in combination with other drugs. It is thought that ixazomib citrate interferes with how multiple myeloma cells breakdown proteins.
This is a clinical research study for patients that have been diagnosed with multiple myeloma and have received an autologous stem cell transplant (ASCT) as part of their myeloma therapy. This study will assess whether taking ixazomib citrate as maintenance therapy after an ASCT extends the period of time that a patient’s cancer stays inactive.
Approximately 652 patients from around the world will take part in this study. Participants will be assigned to receive either ixazomib citrate or placebo (dummy drug) in an oral form (capsule). Each treatment period or “cycle” will last 28 days. Participants will receive the study drug on days 1, 8, and 15. Participants may continue to receive study drug for up to 26 study cycles or 24 months as long as long as they tolerate the therapy and their myeloma does not get worse. After the treatment period ends, participants will continue to be followed up in order to gather additional information about their myeloma, further treatments, quality of life and survival.
The study involves procedures including: medical history, physical exams, questionnaires, status assessments, blood and urine tests, ECG (measures heart rhythm), heart rate, blood pressure, height, breathing rate, temperature, weight, bone marrow biopsy and aspirate, diary completion. Participants may have some of the following: x-rays, CT, PET-CT, or MRI.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/0673
Date of REC Opinion
3 Jun 2014
REC opinion
Further Information Favourable Opinion