A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Stichting European Myeloma Network
Study ID
NCT05257083
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered SC.
  • Bortezomib — DRUG
    Bortezomib will be administered SC.
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally.
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally.
  • Cilta-cel — DRUG
    Cilta-cel will be administered intravenously
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered intravenously.
  • Fludarabine — DRUG
    Fludarabine will be administered intravenously.

Study Details

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

Key Dates

Start date
Oct 10, 2023
Status verified
Dec 2025
Primary completion
Jun 30, 2033
Completion
Aug 31, 2040

Study Design

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

Arms

  • Active Comparator: Arm A: DVRd + ASCT+DVRd (Standard Therapy)
    Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 4 induction cycles. Followed by ASCT and 2 cycles of DVRd consolidation, and lenalidomide maintenance therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
  • Experimental: Arm B: DVRd followed by Ciltacabtagene Autoleucel
    Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 6 induction cycles. Participants will receive a conditioning regimen (cyclophosphamide 300 mg/m\^2 intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily for 3 days) and Cilta-cel infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg), followed by lenalidomide post CAR-T cell therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist of 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: up to 10 years ( or 300 PFS events) ]

Locations (27)

FacilityCityStateZIPSite coordinators
University of ArkansasLittle RockArkansas72205-
City of HopeDuarteCalifornia91010-
UC San Diego Health Moores Cancer CenterSan DiegoCalifornia92093-
University of California San Francisco (UCSF)San FranciscoCalifornia94117-
Stanford UniversityStanfordCalifornia94305-
Moffit Cancer CenterTampaFlorida33612-
Emory University HospitalAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637-
University of IowaIowa CityIowa52242-
University Of Maryland Medical CenterBaltimoreMaryland21201-
Boston Medical CenterBostonMassachusetts02118-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer CenterDetroitMichigan48201-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Mount Sinai Medical CenterNew YorkNew York10029-
University of RochesterRochesterNew York14642-
Montefiore M-E CenterThe BronxNew York10467-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27705-
Cleveland ClinicClevelandOhio44195-
The Ohio State UniversityColumbusOhio43210-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of VirginiaCharlottesvilleVirginia22903-
University of Washington MedicalSeattleWashington98195-
Medical College WisconsinMilwaukeeWisconsin53226-

Find similar trials in Little Rock, AR

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Arkansas· Little Rock, ARCity of Hope· Duarte, CAUC San Diego Health Moores Cancer Center· San Diego, CAUniversity of California San Francisco (UCSF)· San Francisco, CAStanford University· Stanford, CAMoffit Cancer Center· Tampa, FL

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