A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04108195
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Participants will receive daratumumab.
  • Talquetamab — DRUG
    Participants will receive talquetamab.
  • Teclistamab — DRUG
    Participants will receive teclistamab.
  • Pomalidomide — DRUG
    Participants will receive pomalidomide.

Study Details

The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.

Key Dates

Start date
Feb 21, 2020
Status verified
Jun 2026
Primary completion
Apr 7, 2027
Completion
Apr 7, 2027

Study Design

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

Arms

  • Experimental: Part 1: Dose Escalation
    Participants will be assigned to either a combination of 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide.
  • Experimental: Part 2: Dose Expansion
    Participants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1.

Primary Outcome Measure

Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 52 Weeks ]

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
University of California San FranciscoSan FranciscoCalifornia94143-
Mount Sinai Medical CenterNew YorkNew York10029-
The Blavatnik Family Chelsea Medical Center at Mount SinaiNew YorkNew York10011-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
Medical College Of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAUniversity of California San Francisco· San Francisco, CAMount Sinai Medical Center· New York, NYThe Blavatnik Family Chelsea Medical Center at Mount Sinai· New York, NYLevine Cancer Institute· Charlotte, NC

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