A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Purpose

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria - Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen - Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration

Exclusion Criteria

  • All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy - All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment. - All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. - All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Dose Escalation 		Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.
  • Drug: Talquetamab
    Talquetamab will be administered by subcutaneous (SC) injection.
    Other names:
    • JNJ-64407564
  • Drug: Teclistamab
    Teclistamab will be administered by SC injection.
    Other names:
    • JNJ-64007957
  • Drug: Daratumumab
    Daratumumab will be administered by SC injection.
Experimental
Part 2: Dose Expansion 		Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R[s]) of the study treatment identified in Part 1.
  • Drug: Talquetamab
    Talquetamab will be administered by subcutaneous (SC) injection.
    Other names:
    • JNJ-64407564
  • Drug: Teclistamab
    Teclistamab will be administered by SC injection.
    Other names:
    • JNJ-64007957
  • Drug: Daratumumab
    Daratumumab will be administered by SC injection.
Experimental
Part 3: Phase 2 		Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.
  • Drug: Talquetamab
    Talquetamab will be administered by subcutaneous (SC) injection.
    Other names:
    • JNJ-64407564
  • Drug: Teclistamab
    Teclistamab will be administered by SC injection.
    Other names:
    • JNJ-64007957

Recruiting Locations

University of Alabama at Birmingham, Comprehensive Cancer Center
Birmingham, Alabama 35233

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205

Colorado Blood Cancer Institute
Denver, Colorado 80218

Emory University
Atlanta, Georgia 30322

Mayo Clinic
Rochester, Minnesota 55905

Washington University St. Louis School Medicine Siteman Cancer Center
Saint Louis, Missouri 63108

Mount Sinai Medical Center
New York, New York 10029

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Atrium Health
Charlotte, North Carolina 28204

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina 27157

Cleveland Clinic
Cleveland, Ohio 44195

Oregon Health And Science University
Portland, Oregon 97239

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030

More Details

NCT ID
NCT04586426
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Detailed Description

Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Rationale for combining talquetamab and teclistamab is the targeting of multiple proteins on the surface of multiple myeloma cells resulting in cell lysis. This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant). End of study is defined as 2 years after the last participant has received his or her initial dose of the treatment combination. Total duration of study is Approximately 5 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study.