M14-031: Venetoclax in Relapsed/Refractory Multiple Myeloma
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination with Either Venetoclax or Placebo in Subjects with Relapsed or Refractory Multiple Myeloma Who are Sensitive or Naïve to Proteasome Inhibitors
IRAS ID
202124
Contact name
Aliki Danou
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2015-004411-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 28 days
Research summary
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Survival of patients with MM has improved thanks to more effective treatments. Most patients with MM will relapse or become non-responsive to treatment and remission gets shorter after each line of treatment.
One of the standard therapies for MM consists of two drugs taken together: bortezomib (a proteasome inhibitor) and dexamethasone (a steroid). Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to determine if venetoclax added to bortezomib and dexamethasone works better than bortezomib and dexamethasone (Bd) alone.
In this study, 2/3 of patients will receive venetoclax daily with Bd and the remaining 1/3 will receive “dummy” tablets with Bd. This is a Phase 3, randomized, double-blind (treatment type is unknown to patients and doctors) study in MM patients who have relapsed after therapy or did not respond to treatment. Subjects who participate in this study must have only been treated with between 1-3 lines of therapy and must be responsive to, or have not previously been treated with, proteasome inhibitors. AbbVie is funding this study which will take place at roughly 120 secondary care sites and enrol approximately 240 patients.
Patients will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on MM will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1450
Date of REC Opinion
31 Aug 2016
REC opinion
Favourable Opinion