M13-494 (Canova): Phase 3 t(11;14)-positive R/R Multiple Myeloma
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
IRAS ID
245746
Contact name
Rakesh Popat
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2017-003838-88
Duration of Study in the UK
3 years, 4 months, 0 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 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: pomalidomide and dexamethasone. 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 with dexamethasone (VenDex) works better than pomalidomide with dexamethasone (PomDex).
In this study, half of patients will receive VenDex and the other half will receive PomDex. This is a Phase 3, randomised, open-label (treatment type is known to patients, investigators and the sponsor) study in MM patients who have relapsed or were non-responsive to treatment. Patients who participate in this study must have had at least two lines of treatment, including treatment with lenalidomide and a type of drug called a proteasome inhibitor. Also, their MM cells must have a chromosome translocation (change in the DNA) called t(11;14).
Patients will continue to receive study treatment for as long as they are having a clinical benefit. Those taking PomDex could switch, if determined to be qualified, to receiving VenDex, once their cancer worsens. The effect of the treatment on MM will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.
AbbVie is funding this study which will take place at roughly 90 secondary care sites and enrol approximately 244 patients.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1289
Date of REC Opinion
5 Sep 2018
REC opinion
Further Information Favourable Opinion