A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

NCT07258511 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 79635322MMY30012025-522007-18-00
• Study Type: interventional
• Target: 400
• Locations: 5 countries
• Sites: 39

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 5 years and 4 months

Secondary Outcomes (24)

• Very Good Partial Response (VGPR) or Better

  Up to 5 years and 4 months

• Complete Response (CR) or Better

  Up to 5 years and 4 months

• Duration of Response (DoR)

  Up to 5 years and 4 months

• Minimal Residual Disease (MRD)-negative CR

  Up to 5 years and 4 months

• MRD-negative CR at 9 months

  9 months

Study Arms (2)

JNJ-79635322

EXPERIMENTAL

Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.

Drug: JNJ-79635322

Anti BCMAxCD3 Bispecific Antibody

ACTIVE COMPARATOR

Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.

Drug: Teclistamab

Interventions

JNJ-79635322 DRUG

JNJ-79635322 will be administered as SC injection.

JNJ-79635322

Teclistamab DRUG

Teclistamab will be administered as SC injection.

Anti BCMAxCD3 Bispecific Antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
• MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (39)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33901, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Mission Cancer Blood

Waukee, Iowa, 50263, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

RECRUITING

Mount Sinai Brooklyn

Brooklyn, New York, 11234, United States

RECRUITING

Mount Sinai Chelsea

New York, New York, 10011, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Durham VAMC

Durham, North Carolina, 27705, United States

RECRUITING

Oregon Health And Science University

Portland, Oregon, 97239, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Box Hill Hospital

Box Hill, 3128, Australia

RECRUITING

Mater Misericordiae Ltd

Brisbane, 4101, Australia

RECRUITING

Monash Medical Centre

Clayton, 3168, Australia

RECRUITING

St Vincents Hospital Melbourne

Fitzroy, 3065, Australia

RECRUITING

The Alfred Hospital

Melbourne, 3004, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, 6150, Australia

RECRUITING

Gold Coast University Hospital

Southport, 4215, Australia

RECRUITING

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035 903, Brazil

SUSPENDED

Soroka Medical Center

Beersheba, 8457108, Israel

RECRUITING

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

RECRUITING

Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

Shaare Zedek MC

Jerusalem, 9103102, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

Baruch Padeh MC

Ramat Poriya, 1520800, Israel

RECRUITING

Assuta MC

Tel Aviv, 69710, Israel

RECRUITING

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, 113 8677, Japan

RECRUITING

Chiba Cancer Center

Chiba, 260 0801, Japan

RECRUITING

Shonan Kamakura General Hospital

Kamakura-shi, 247-8533, Japan

RECRUITING

Kameda Medical Center

Kamogawa, 296-8602, Japan

RECRUITING

Yamanashi Prefectural Central Hospital

Kofu, 400-0027, Japan

RECRUITING

The Jikei University Hospital

Minato, 105-8471, Japan

RECRUITING

Japanese Red Cross Medical Center

Shibuya City, 150-8935, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, 241 8515, Japan

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 12, 2028
• Study Completion (Estimated): September 30, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (15); AU (7); IL (8); BR (1); JP (8)