MonumenTAL-2
Research type
Research Study
Full title
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants with Multiple Myeloma
IRAS ID
306383
Contact name
Emma Searle
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-004502-55
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 19 days
Research summary
This is an open-label, non-randomised, multi-centre, Phase 1b study to evaluate the safety and tolerability (the degree to which overt adverse effects of a drug can be tolerated) of talquetamab (the study drug) in combination treatment regimens, as well as to identify the safe dose(s) to take forward for subsequent evaluation of these combination regimens in the treatment of participants with multiple myeloma.\n\nTalquetamab is a bispecific antibody (a protein used by the immune system) that has two arms. One targets a protein on myeloma cells (called GPRC5D), and another targets CD3 (another protein) on the body’s immune system cells. Talquetamab can bring T-cells to the myeloma cell, resulting in myeloma cell death.\n\nParticipants will be assigned to 1 of 5 treatment regimens (that will run in parallel) based on the participant’s disease characteristics and prior treatment for multiple myeloma. The treatment regimens are talquetamab and carfilzomib (regimen A), talquetamab, daratumumab and carfilzomib (regimen B), talquetamab and lenalidomide (regimen C), talquetamab and daratumumab with lenalidomide (regimen D) and talquetamab and pomalidomide (regimen E). \n\nThe purpose of the study is to assess the safety of talquetamab (also named JNJ64407564) when administered with the other treatments specified for each regimen, and to identify the safe dose(s) of each treatment combination regimen. Another purpose of the study is to find out how long talquetamab stays in and acts on the body. In addition, this study will evaluate how each treatment combination might fight multiple myeloma.\n\nThe study consists of a Screening Period (up to 28 days), a Treatment Period, and a Post-treatment Follow-up Period (up to 16 weeks, unless extended for participants requiring further blood testing).
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0011
Date of REC Opinion
24 Feb 2022
REC opinion
Further Information Favourable Opinion