A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04722146
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Teclistamab — DRUG
    Participants will receive teclistamab.
  • Daratumumab — DRUG
    Participants will receive daratumumab.
  • Pomalidomide — DRUG
    Participants will receive pomalidomide.
  • Lenalidomide — DRUG
    Participants will receive lenalidomide.
  • Bortezomib — DRUG
    Participants will receive bortezomib.
  • Nirogacestat — DRUG
    Participants will receive nirogacestat.

Study Details

The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

Key Dates

Start date
Mar 12, 2021
Status verified
Jun 2026
Primary completion
Oct 13, 2025
Completion
Oct 13, 2027

Study Design

Enrollment
140 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
    Participants will receive teclistamab plus daratumumab plus pomalidomide.
  • Experimental: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
    Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
  • Experimental: Treatment Regimen C: Teclistamab + Nirogacestat
    Participants will receive teclistamab plus nirogacestat.
  • Experimental: Treatment Regimen D: Teclistamab + Lenalidomide
    Participants will receive teclistamab plus lenalidomide.
  • Experimental: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
    Participants will receive teclistamab plus daratumumab plus lenalidomide.
  • Experimental: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
    Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.

Primary Outcome Measure

Number of Participants with Incidence of Adverse Events (AEs) [ Time Frame: Up to 2 year and 5 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
University of California San FranciscoSan FranciscoCalifornia94143-
Colorado Blood Cancer InstituteDenverColorado80218-
Winship Cancer Institute Emory UniversityAtlantaGeorgia30322-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Washington University School Of MedicineSt LouisMissouri63110-1032-
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-
Weill Cornell Medical CollegeNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Tennessee OncologyNashvilleTennessee37203-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Medical College Of WisconsinMilwaukeeWisconsin53226-

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