A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06577025
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cilta-cel — DRUG
    Cilta-cel infusion will be administered intravenously.
  • Talquetamab — DRUG
    Talquetamab will be administered subcutaneously.
  • Daratumumab — DRUG
    Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation.
  • Teclistamab — DRUG
    Teclistamab will be administered subcutaneously.
  • Bortezomib — DRUG
    Bortezomib will be administered subcutaneously as a part of induction.
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally as a part of induction.
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally as a part of induction.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered intravenously as a part of conditioning regimen.
  • Fludarabine — DRUG
    Fludarabine will be administered intravenously as a part of conditioning regimen.

Study Details

The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.

Key Dates

Start date
Aug 20, 2024
Status verified
Jun 2026
Primary completion
Sep 2, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: DVRd Induction + Tal-D Consolidation + Cilta-cel
    Participants will undergo apheresis followed by 4 cycles of DVRd induction (each cycle is of 28 days) and cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release, and completion of induction, participants will begin consolidation with 4 cycles of Tal-D (each cycle is of 28 days), followed by a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days); cilta-cel will be administered 5 to 7 days after the start of the conditioning regimen.
  • Experimental: Cohort B: DVRd Induction + Cilta-cel + Tal-D and Tec-D Consolidation
    Participants will undergo apheresis followed by 4 cycles of DVRd induction and Cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release and completion of induction, participants will begin consolidation with a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days) with infusion of cilta-cel 5 to 7 days after the start of the conditioning regimen. Following cilta-cel infusion, alternating cycles of Tal-D (Cycle 1, 3, 5, and 7) and Tec-D (Cycle 2, 4, 6, and 8) will be started, no earlier than Day 84 and no later than Day 168 post cilta-cel infusion. Each cycle of Tal-D or Tec-D is 84 days which includes an extended treatment-free interval.

Primary Outcome Measure

Rate of Response with Curative Potential [ Time Frame: Up to 5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California San FranciscoSan FranciscoCalifornia94143-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAUniversity of California San Francisco· San Francisco, CAUniversity of Iowa Hospital and Clinics· Iowa City, IAMemorial Sloan Kettering Cancer Center· New York, NYLevine Cancer Institute· Charlotte, NC

Related Studies