Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03399799
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Hematological Malignancies

Eligibility Criteria

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

Interventions

  • Talquetamab — DRUG
    Participants will receive IV infusion or SC injection of Talquetamab.

Study Details

The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 \[Dose Escalation\]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 \[Dose Expansion\]).

Key Dates

Start date
Dec 16, 2017
Status verified
Jun 2026
Primary completion
Jul 7, 2022
Completion
Oct 20, 2027

Study Design

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

Arms

  • Experimental: Part 1: Dose Escalation (Talquetamab) - Intravenous (IV)
    Participants will receive IV infusion of Talquetamab at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data. Participants receiving IV dosing can transition to SC dosing through-out the study upon sponsor consultation. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment.
  • Experimental: Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC)
    Participants will receive Talquetamab SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s). All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
  • Experimental: Part 2: Dose Expansion (Talquetamab)
    Participants will receive IV infusion or SC injection of Talquetamab at each putative recommended Phase 2 dose(s) (RP2D\[s\]) as determined in Part 1. Participants receiving IV dosing can transition to SC dosing through-out the study upon sponsor consultation. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.

Primary Outcome Measure

Part 1: Dose-limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35294-
City of HopeDuarteCalifornia91010-
University of Colorado Cancer CenterAuroraColorado80045-
Mount Sinai Medical CenterNew YorkNew York10029-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Birmingham, AL

By research site
University of Alabama Birmingham· Birmingham, ALCity of Hope· Duarte, CAUniversity of Colorado Cancer Center· Aurora, COMount Sinai Medical Center· New York, NYTennessee Oncology· Nashville, TN

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