Phase 1b Multi-arm study of Teclistamab - Protocol 64007957MMY1004
Research type
Research Study
Full title
A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants with Multiple Myeloma
IRAS ID
292014
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V
Eudract number
2020-004404-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 4 days
Research summary
This is a Multi-arm Phase 1b study of Teclistamab with other anticancer therapies in participants with Multiple Myeloma at different stages of their disease. The three regimens being studied are as follows:
- Regimen A: Patients with relapsed refractory Multiple Myeloma who have received at least 1 prior line of therapy, including a PI and lenalidomide. Treated with Teclistamab + Daratumumab + Pomalidomide.
- Regimen B: Patients with newly diagnosed Multiple Myeloma who are lenalidomide naïve. Treated with Teclistamab + Daratumumab + Lenalidomide + Bortezomib.
- Regimen C: Patients with relapsed refractory Multiple Myeloma who have received 3 or more prior lines of therapy or who are double refractory and triple exposed. Treated with Teclistamab + Nirogacestat, until progressive disease or other reason for withdrawal.
At least 20 participants are to be enrolled under each regimen, all participants will receive the study drug teclistamab and combination therapy. Teclistamab is an antibody; antibodies are proteins that attach to specific targets on cells or tissues to help the body fight cancer, infections and other diseases.
Although there are treatments available for multiple myeloma, the disease is still incurable. The increasing number of patients with this disease requires new therapies to address this unmet medical need.
The purpose of this study is to evaluate the safety and tolerability of Teclistamab combination regimens, as well as the antitumour activity of each treatment combination.
Potential patients will go through a screening phase of up to 28days to determine their suitability for the study with various health tests.
If eligible and the patient wants to participate then they will move into the treatment phase of the study. Each treatment cycle lasts:
- Regimen A: 28-day cycles
- Regimen B: Cycle 1-8 21-day cycles- followed by 28-day cycles
- Regimen C: 28-day cyclesOn completion of treatment participants go into a 16 week follow-up period, collecting data on anticancer drugs and patient wellbeing.
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0136
Date of REC Opinion
18 Mar 2021
REC opinion
Further Information Favourable Opinion