Phase 2 Dose escalation & expansion study in R/R Multiple Myeloma
Research type
Research Study
Full title
A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
IRAS ID
245748
Contact name
Penny Newson
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-004232-11
Duration of Study in the UK
years, months, 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 (cancer has come back) 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, pomalidomide and dexamethasone can be safely combined in patients with MM that have relapsed or are no longer responding to treatment. Patients who take part in this study must have had at least 1 prior treatment, including treatment with lenalidomide and a type of drug called a proteasome inhibitor.
This is a Phase 2, open-label study. All patients in this study with receive venetoclax, pomalidomide and dexamethasone. The study will consist of 2 parts: Part 1 (to confirm a dose of venetoclax) and Part 2 (to further test the dose found in Part 1). About 6-12 patients globally will take part in Part 1 and about 50 patients globally will take part in Part 2.
Patients will receive venetoclax and pomalidomide for as long as they are having clinical benefit. Patients can stop taking pomalidomide and/or dexamethasone but continue taking venetoclax for up to 2 years after the last patient has started the study.
Patients will attend regular study visits to the hospital. The effect of the treatment on the MM will be checked by taking blood, bone marrow, scans and measuring side effects.
AbbVie is funding this study which will take place at about 15 sites globally.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0400
Date of REC Opinion
1 Oct 2018
REC opinion
Further Information Favourable Opinion