Tests ciltacabtagene autoleucel in people with multiple myeloma
Tests cilta-cel, a cell therapy, with different preparation treatments in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Key facts
- Where
- Charlotte, Cleveland, Iowa City, New York, San Francisco, Tampa, and Winston-Salem, United StatesSee the 7 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07149857, who can take part
Where in United States
- Atrium HealthCharlotte, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesTaking people
- University of Iowa Hospital and ClinicsIowa City, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
- Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer CenterWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07149857EU 2025-521975-30-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2 Multicohort Trial to Further Characterize the 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.
Inclusion: 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 abnormal serum free light chain ratio; Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment; Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved >= partial response (PR) on the most recent disease assessment to be enrolled; Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1; Must be willing and able to adhere to the lifestyle restrictions specified in the protocol.
Exclusion: Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib; Known allergies, hypersensitivity, or intolerance to study intervention or its active agents; Frailty index of >= 2 according to Myeloma Geriatric Assessment score; Participants who require continuous supplemental oxygen.