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A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Trial Status: active
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 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 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 Criteria
Frailty index of >= 2 according to Myeloma Geriatric Assessment score
Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
Participants who require continuous supplemental oxygen
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07149857.
