Treatment Continuation for Subjects from prior Elotuzumab trials
Research type
Research Study
Full title
Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab
IRAS ID
285325
Contact name
Rebecca Rai
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-000037-51
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
100,043, IND
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Multiple myeloma is a malignancy of plasma cells and is one of the most frequent cancers of the bone marrow. Following initial treatment for myeloma, almost all patients will suffer relapse regardless of the therapy used. Hence, there is a significant unmet need for new treatments for multiple myeloma.
The research study CA204-006 was done to determine whether the addition of an investigational agent (Elotuzumab) to standard therapy (Lenalidomide and Dexamethasone) is better than treatment with standard therapy alone in the relapsed/refractory multiple myeloma population. This study CA204-185 also assessed the safety of Elotuzumab combined with standard therapy.
The purpose of this study CA204-185 is to provide Elotuzumab and/or other study drugs to participants who benefited from the previous research study and who are not able to receive commercial drug supply. Eligible participants will continue receiving study drug treatment at the last dose and schedule used in the previous research study until the study doctor concludes that the participant is no longer benefiting from the treatment. The safety and tolerability of Elotuzumab will still continue to be monitored in these participants.
This is an “open label” study, which means that both the participant and study doctor will know which drugs the participant is receiving.
The study will continue until all participants have stopped receiving study drugs or until all participants are treated for up to 2 years, unless the Sponsor chooses to extend the study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0291
Date of REC Opinion
3 Feb 2021
REC opinion
Further Information Favourable Opinion