A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

Trial Details

NCT ID

NCT07149857

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Status

RECRUITING

Cancer Type

Multiple Myeloma

Interventions

Cilta-cel
Cyclophosphamide
Induction therapy
Fludarabine

Locations (sample)

San Francisco, California, United States|37.77493,-122.41942
Tampa, Florida, United States|27.94752,-82.45843
Iowa City, Iowa, United States|41.66113,-91.53017
New York, New York, United States|40.71427,-74.00597
Charlotte, North Carolina, United States|35.22709,-80.84313

Key Eligibility Criteria

Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic …
Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid conditio…
Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet ind…
Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

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