A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel (CARTITUDE-10)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Fludarabine; Drug: Induction therapy; Drug: Cilta-cel; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07149857

68284528MMY2012 (Other Identifier)

2025-521975-30-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cohort A

Experimental group

Description:

Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

Treatment:

Drug: Cyclophosphamide

Drug: Cilta-cel

Drug: Induction therapy

Cohort B

Experimental group

Description:

Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide and fludarabine daily for 3 days, followed by Ciltacel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

Treatment:

Drug: Cyclophosphamide

Drug: Cilta-cel

Drug: Induction therapy

Drug: Fludarabine