A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

Part of paid clinical trials in San Diego, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04133636
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • JNJ-68284528 — DRUG
    Participants in Cohorts A,B,C, D, E, F and Cohort G (for US sites only) will receive JNJ-68284528 intravenously.
  • Lenalidomide — DRUG
    Some participants in Cohort D and all participants in Cohorts E and Cohort G (for US sites only) will also receive lenalidomide capsules orally.
  • Daratumumab — DRUG
    Participants in Cohorts E and Cohort G (for US sites only) will also receive daratumumab subcutaneous (SC) injection.
  • Bortezomib — DRUG
    Participants in Cohorts E will also receive bortezomib subcutaneously.
  • Dexamethasone — DRUG
    Participants in Cohorts E and Cohort G (for US sites only) will also receive dexamethasone orally or intravenously.

Study Details

The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

Key Dates

Start date
Nov 7, 2019
Status verified
Jun 2026
Primary completion
Aug 4, 2026
Completion
Sep 3, 2029

Study Design

Enrollment
208 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JNJ-68284528
    Single group assignment-Post lymphodepletion, JNJ-68284528 single infusion given to Part A participants: Cohort A (Progressive disease post 1-3 prior lines of therapy), Cohort B (Early relapse post front-line), Cohort C(Relapsed/refractory multiple myeloma post PI, IMiD,anti-CD38,anti-BCMA therapy), Cohort D(Less than CR post ASCT front-line therapy, some participants will receive JNJ-68284528 then lenalidomide), Cohort F(Newly diagnosed multiple myeloma \[NDMM\], standard risk \[International Staging System Stage I/II\] and post initial therapy); Cohort E(NDMM,transplant not planned, high risk disease) will first receive quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone(D-VRd) then lymphodepletion and JNJ-68284528 then consolidation regimen of lenalidomide. Enrollment is closed for Cohorts A,B,C,D,E and F. For US sites only: Part B:Cohort G (NDMM, transplant not planned) will receive daratumumab, lenalidomide and dexamethasone followed by cilta-cel.

Primary Outcome Measure

Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD) [ Time Frame: At least 1 year after JNJ-68284528 infusion on Day 1 ]

Locations (33)

FacilityCityStateZIPSite coordinators
University Of California San DiegoSan DiegoCalifornia92037-
University of California San FranciscoSan FranciscoCalifornia94143-
Yale University School Of MedicineNew HavenConnecticut06510-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
Indiana UniversityIndianapolisIndiana46202-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of Kansas Cancer CenterWestwoodKansas66205-
Norton Cancer InstituteLouisvilleKentucky40207-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Mayo Clinic RochesterRochesterMinnesota55905-
Washington University School Of MedicineSt LouisMissouri63108-
Hackensack University Medical CenterHackensackNew Jersey07601-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Mount Sinai Medical CenterNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10467-
Levine Cancer Institute, Carolinas HealthCare SystemCharlotteNorth Carolina28204-
Cleveland ClinicClevelandOhio44195-
Oregon Health And Science UniversityPortlandOregon97239-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of PittsburghPittsburghPennsylvania15232-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of UtahSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22908-
Virginia Commonwealth University - Massey Cancer CenterRichmondVirginia23298-
Fred Hutchinson Cancer CenterSeattleWashington98109-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53705-

Find similar trials in San Diego, CA

By condition
Multiple myeloma
By specialty
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By research site
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