Study on the Effectiveness and Safety of Ciltacabtagene Autoleucel
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT07149857
This clinical trial is testing how well a treatment called cilta-cel works when given with different methods to reduce certain white blood cells in the body. The study aims to find the best way to administer cilta-cel for treating patients.
Patient Parameters
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Program Overview
The goal of this study is to determine how effective and safe the treatment cilta-cel is when used with different methods to lower the number of lymphocytes, a type of white blood cell. One method does not use fludarabine, while the other method involves giving cilta-cel after using both cyclophosphamide and fludarabine to reduce lymphocytes. The study will help find the best approach for administering cilta-cel to patients.
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Iowa Hospital and Clinics | 52242 | Iowa City | Iowa |
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