A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Aug 9, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two treatments, Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab, for patients with high-risk multiple myeloma, a type of blood cancer. The goal is to evaluate how safe these treatments are for participants. The trial is currently looking for volunteers aged 65 and older who have a confirmed diagnosis of multiple myeloma and have either received multiple prior treatments or are newly diagnosed but not eligible for a specific type of intense therapy called autologous stem cell transplant.
If you join the trial, you will receive either of the study drugs and be monitored closely for any side effects. It’s important to note that certain patients may not qualify, such as those who have had specific prior therapies or recent stem cell transplants. Participating in this study could offer a new treatment option for those facing high-risk multiple myeloma, and it contributes to research that may help others in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
- • Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy
- • Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
- • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- • Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening
- Exclusion Criteria:
- • Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy
- • Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment
- • Receive live, attenuated vaccine within 4 weeks of enrollment
- • Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- • Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Detroit, Michigan, United States
New York, New York, United States
San Francisco, California, United States
Philadelphia, Pennsylvania, United States
New York, New York, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Camperdown, , Australia
Melbourne, , Australia
Heidelberg, , Australia
Melbourne, , Australia
New York, New York, United States
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported