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RecruitingInterventionalPhase 3

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

NCT ID: NCT07258511Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

Summary

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Arms & interventions

  • DrugJNJ-79635322

    JNJ-79635322 will be administered as SC injection.

  • DrugTeclistamab

    Teclistamab will be administered as SC injection.

Outcome measures

Primary

  • Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria.

    Time frame: Up to 5 years and 4 months

  • Progression-Free Survival (PFS)

    PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.

    Time frame: Up to 5 years and 4 months

Secondary

  • Very Good Partial Response (VGPR) or Better

    Time frame: Up to 5 years and 4 months

  • Complete Response (CR) or Better

    Time frame: Up to 5 years and 4 months

  • Duration of Response (DoR)

    Time frame: Up to 5 years and 4 months

  • Minimal Residual Disease (MRD)-negative CR

    Time frame: Up to 5 years and 4 months

  • MRD-negative CR at 9 months

    Time frame: 9 months

  • Sustained MRD-negative CR

    Time frame: Up to 5 years and 4 months

  • Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)

    Time frame: Up to 5 years and 4 months

  • Overall Survival (OS)

    Time frame: Up to 5 years and 4 months

  • Time To Next Line of Therapy (TTNT)

    Time frame: Up to 5 years and 4 months

  • Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity

    Time frame: Up to 5 years and 4 months

  • Number of Participants with Abnormalities in Clinical Laboratories Results

    Time frame: Up to 5 years and 4 months

  • Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score

    Time frame: Baseline up to 5 years and 4 months

  • Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score

    Time frame: Baseline up to 5 years and 4 months

  • Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score

    Time frame: Baseline up to 5 years and 4 months

  • Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score

    Time frame: Up to 5 years and 4 months

  • Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score

    Time frame: Up to 5 years and 4 months

  • Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score

    Time frame: Up to 5 years and 4 months

  • Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score

    Time frame: Up to 5 years and 4 months

  • Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score

    Time frame: Up to 5 years and 4 months

  • Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score

    Time frame: Up to 5 years and 4 months

  • Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46)

    Time frame: Up to 5 years and 4 months

  • Serum Concentrations for JNJ-79635322

    Time frame: Up to 5 years and 4 months

  • Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322

    Time frame: Up to 5 years and 4 months

  • Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322

    Time frame: Up to 5 years and 4 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion: * Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: 1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria 2. Measurable disease at screening as assessed by central laboratory * Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody * Documented evidence of progressive disease (PD) or failure to achieve a response (that is partial response \[PR\] or better) to the last line of therapy based on investigator's determination of response by IMWG criteria * Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration Exclusion: * Active hepatitis of infectious origin * Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM * Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab * Major surgery , (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, during, or within 90 days after the last dose of study treatment

Study locations (23)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Recruiting

University of Connecticut Health Center

Farmington, Connecticut, 06030

Recruiting

Yale Cancer Center

New Haven, Connecticut, 06510

Recruiting

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33901

Recruiting

Moffit Cancer center

Tampa, Florida, 33612

Recruiting

Emory University

Atlanta, Georgia, 30322

Recruiting

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

Recruiting

Mission Cancer Blood

Waukee, Iowa, 50263

Recruiting

Norton Cancer Institute

Louisville, Kentucky, 40207

Recruiting

Mount Sinai Brooklyn

Brooklyn, New York, 11234

Recruiting

NYU Winthrop

Mineola, New York, 11501

Recruiting

Mount Sinai Chelsea

New York, New York, 10011

Recruiting

Laura and Isaac Perlmutter Cancer Center NYU ACC

New York, New York, 10016

Recruiting

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Durham VAMC

Durham, North Carolina, 27705

Recruiting

Oregon Health And Science University

Portland, Oregon, 97239

Recruiting

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

St. David's South Austin Medical Center

Austin, Texas, 78704

Recruiting

Baylor University Medical Center

Dallas, Texas, 75246

Recruiting

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Recruiting