A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT07518186 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 79635322MMY3002
• Study Type: interventional
• Target: 700
• Locations: 4 countries
• Sites: 8

Brief Summary

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Complete Response (CR) or Better

  CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.

  Up to approximately 41 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 approximately 41 months

Secondary Outcomes (21)

• Overall Response Rate (ORR)

  Up to approximately 41 months

• Very Good Partial Response (VGPR) or Better

  Up to approximately 41 months

• Duration of Response (DoR)

  Up to approximately 41 months

• Minimal Residual Disease (MRD)-negative CR

  Up to approximately 41 months

• MRD-negative CR at 1 Year

  At 1 Year

Study Arms (2)

Arm A: JNJ-79635322

EXPERIMENTAL

Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).

Drug: JNJ-79635322

Arm B: Teclistamab

ACTIVE COMPARATOR

Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.

Drug: Teclistamab

Interventions

Teclistamab DRUG

Teclistamab will be administered as SC injection.

Arm B: Teclistamab

JNJ-79635322 DRUG

JNJ-79635322 will be administered as SC injection.

Arm A: JNJ-79635322

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: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
• Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
• Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
• Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment

You may not qualify if:

• Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to 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
• Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
• Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
• Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (8)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Rambam Med.Center - Hematology Institute

Haifa, 3109601, Israel

RECRUITING

Carmel Medical Center

Haifa, 3436212, Israel

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

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: April 1, 2026
• First Posted: April 8, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): April 29, 2029
• Study Completion (Estimated): December 8, 2032
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

TW (3); US (2); IL (2); TU (1)