Status:
RECRUITING
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 whit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07149857
Start Date
October 3 2025
End Date
December 29 2028
Last Update
December 5 2025
Active Locations (9)
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1
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
2
Royal Prince Alfred Hospital
Camperdown, Australia, 2050
3
Austin Hospital
Heidelberg, Australia, 3084
4
Hosp. Clinic de Barcelona
Barcelona, Spain, 08036