CAR T-Cell Therapy for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophosphamide (a lymphodepleting chemotherapy) * Fludarabine (a lymphodepleting chemotherapy)
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, certain therapies like chemotherapy, immunotherapy, and radiotherapy are not allowed during the trial, so it's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Ciltacabtagene Autoleucel (cilta-cel) for multiple myeloma?
Ciltacabtagene autoleucel (cilta-cel) has shown to be effective in patients with relapsed or refractory multiple myeloma, especially those who have already tried several other treatments. It has been approved by the FDA as a fifth-line option due to its ability to induce early, deep, and long-lasting responses, as demonstrated in the CARTITUDE-1 study.12345
Is CAR T-Cell Therapy for Multiple Myeloma safe?
What makes the treatment ciltacabtagene autoleucel unique for multiple myeloma?
Ciltacabtagene autoleucel is a personalized CAR T-cell therapy that targets a specific protein (BCMA) on cancer cells, offering deep and long-lasting responses for patients with multiple myeloma who have tried many other treatments. It uses the patient's own modified T-cells to attack the cancer, making it a novel option compared to traditional therapies.12489
Research Team
Irene Ghobrial, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults over 18 with high-risk smoldering myeloma, which isn't yet causing symptoms. Participants should have certain blood and bone marrow conditions but no recent other cancers or major illnesses. They must be able to perform daily activities with ease (ECOG PS 0 or 1) and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-In
Participants undergo apheresis, stem cell collection, and receive cyclophosphamide and fludarabine followed by hospitalization for Cilta-cel administration
Cilta-Cel Dose Expansion
Expansion cohort participants undergo similar procedures as the safety run-in phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Extended monitoring for safety and effectiveness up to 15 years
Treatment Details
Interventions
- Ciltacabtagene Autoleucel
- Cyclophosphamide
- Fludarabine Phosphate
Ciltacabtagene Autoleucel is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Relapsed and refractory multiple myeloma after one or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide
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Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Janssen Research & Development, LLC
Industry Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires