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RecruitingInterventionalPhase 2

A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

NCT ID: NCT07266441Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

Summary

The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.

Arms & interventions

  • DrugJNJ-79635322

    JNJ-79635322 will be administered as an injection under the skin.

Outcome measures

Primary

  • Overall Response Rate (ORR)

    Time frame: Up to 2 years and 9 months

Secondary

  • Very Good Partial Response (VGPR) or Better Rate

    Time frame: Up to 2 years and 9 months

  • Complete Response (CR) or Better Rate

    Time frame: Up to 2 years and 9 months

  • Duration of Response (DoR)

    Time frame: Up to 2 years and 9 months

  • Progression-Free Survival (PFS)

    Time frame: Up to 2 years and 9 months

  • Overall Survival (OS)

    Time frame: Up to 2 years and 9 months

  • Time To Next Line of Therapy (TTNT)

    Time frame: Up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 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) Scale Score

    Time frame: From Baseline up to 2 years and 9 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) Scale Score

    Time frame: From Baseline up to 2 years and 9 months

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

    Time frame: From Baseline up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 months

  • Serum Concentrations for JNJ-79635322

    Time frame: Up to 2 years and 9 months

  • Number of Participants With Anti JNJ-79635322 Antibodies

    Time frame: Up to 2 years and 9 months

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

    Time frame: Up to 2 years and 9 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 monoclonal antibody (mAb) * Documented evidence of progressive disease(PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by the 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 (PS) of 0 to 2 at screening and immediately before the start of study treatment administration Exclusion: * Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322 * Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase * Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM * Participant has leptomeningeal disease * Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment

Study locations (29)

O Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, 35294

Recruiting

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

Recruiting

City of Hope

Duarte, California, 91010

Recruiting

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618

Recruiting

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720

Recruiting

University of California San Francisco

San Francisco, California, 94143

Recruiting

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012

Recruiting

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Recruiting

Cancer Specialists of North Florida

Jacksonville, Florida, 32256

Recruiting

Emory University

Atlanta, Georgia, 30322

Recruiting

Northside Hospital Cancer Institute

Atlanta, Georgia, 30342

Recruiting

Cancer Care Specialists of Central Illinois

O'Fallon, Illinois, 62269

Recruiting

University of Iowa

Iowa City, Iowa, 52242

Recruiting

Mission Cancer Blood

Waukee, Iowa, 50263

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Cleveland Clinic Foundtation

Cleveland, Ohio, 44195

Recruiting

Oncology Associates of Oregon PC Willamette Valley Cancer Institute

Eugene, Oregon, 97401

Recruiting

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203

Recruiting

Texas Oncology

Austin, Texas, 78705

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Oncology Consultants Texas

Houston, Texas, 77030

Recruiting

Texas Oncology - Northeast

Tyler, Texas, 75702

Recruiting

Virginia Cancer Specialists

Fairfax, Virginia, 22031

Recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting

NorthWest Medical Specialties, PLLC

Tacoma, Washington, 98405

Recruiting