A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
NCT ID: NCT06550895
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
11 participants
INTERVENTIONAL
2024-09-16
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy
Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.
Cilta-cel
Cilta-cel infusion will be administered intravenously.
Talquetamab
Talquetamab will be administered subcutaneously.
Interventions
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Cilta-cel
Cilta-cel infusion will be administered intravenously.
Talquetamab
Talquetamab will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
Camperdown, , Australia
Austin Hospital
Heidelberg, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
The Alfred Hospital
Melbourne, , Australia
Countries
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Other Identifiers
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64407564MMY2008
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507989-76-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
64407564MMY2008
Identifier Type: -
Identifier Source: org_study_id