A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel
Janssen Research & Development, LLC
Summary
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (\>=)1.0 grams per deciliter (g/dL) or urine M-protein level \>= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain \>= 10 mg/dL and abn…
Interventions
- DrugCilta-cel
Cilta-cel will be administered as intravenous infusion.
- DrugCyclophosphamide
Cyclophosphamide will be administered as intravenous infusion.
- DrugInduction therapy
Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered.
- DrugFludarabine
Fludarabine will be administered as intravenous infusion.
Locations (17)
- University of California San FranciscoSan Francisco, California
- Moffitt Cancer CenterTampa, Florida
- University of Iowa Hospital and ClinicsIowa City, Iowa
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Cleveland ClinicCleveland, Ohio
- Royal Prince Alfred HospitalCamperdown