Study on the Combination of Talquetamab and Teclistamab for Treating Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT04586426
This clinical trial is testing a new combination of drugs, talquetamab and teclistamab, to find the best treatment plan and to see if it is safe and effective for patients with multiple myeloma that has returned or is not responding to other treatments.
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Program Overview
The study aims to determine the best way to use a combination of two drugs, talquetamab and teclistamab, to treat patients with multiple myeloma that has come back or is not responding to other treatments. It will also assess the safety and effectiveness of this treatment. The study is divided into three parts: finding the best treatment plan, checking the safety of the treatment, and evaluating how well it works against cancer. Participants will go through a screening phase, a treatment phase, and a follow-up phase. The study will last about 5 years, with each participant being monitored for up to 2 years after starting the treatment.
Description
Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow, leading to the production of abnormal proteins. This study is exploring a new treatment approach by combining two drugs, talquetamab and teclistamab, which target specific proteins on the surface of myeloma cells to destroy them. The study includes three phases: a screening phase to determine eligibility, a treatment phase where participants receive the study drugs, and a follow-up phase to monitor their health after treatment. The entire study will last approximately 5 years, with each participant being followed for up to 2 years after starting the treatment. Researchers will evaluate the treatment's effectiveness, safety, and how the body processes the drugs. Participants' health and the study's progress will be closely monitored throughout.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma based on specific medical criteria.
- For Parts 1 and 2: Have multiple myeloma that has returned or is not responding to standard treatments, including the most recent treatment.
- For Part 3: Have multiple myeloma that has returned or is not responding to treatment, and have been treated with specific types of drugs before.
- Have a performance status score indicating good overall health, with specific scores required for different parts of the study.
Exclusion Criteria
- Have received certain targeted therapies or investigational treatments within 21 days before starting the study.
- Have had an allogeneic stem cell transplant within 6 months before starting the study.
- Have cancer that has spread to the central nervous system or signs of meningeal involvement.
- Have active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
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