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Search / Trial NCT06550895

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.

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

0 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