A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma (TRIlogy-4)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: JNJ-79635322; Drug: Teclistamab

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Australia
  • Box Hill, Australia, 3128
    • Recruiting
    • Box Hill Hospital
  • Brisbane, Australia, 4101
    • Recruiting
    • Mater Misericordiae Ltd
  • Clayton, Australia, 3168
    • Recruiting
    • Monash Medical Centre
  • Fitzroy, Australia, 3065
    • Recruiting
    • St Vincents Hospital Melbourne
  • Melbourne, Australia, 3004
    • Recruiting
    • The Alfred Hospital
  • Murdoch, Australia, 6150
    • Recruiting
    • Fiona Stanley Hospital
  • Southport, Australia, 4215
    • Recruiting
    • Gold Coast University Hospital
• Brazil
  • Porto Alegre, Brazil, 90035 903
    • Suspended
    • Hospital de Clinicas de Porto Alegre
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Recruiting
      • Arthur J E Child Comprehensive Cancer Centre
• Israel
  • Beersheba, Israel, 8457108
    • Recruiting
    • Soroka Medical Center
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center
  • Haifa, Israel, 34362
    • Recruiting
    • Carmel Medical Center
  • Haifa, Israel, 31048
    • Recruiting
    • Bnai Zion Medical Center
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek MC
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
  • Ramat Poriya, Israel, 1520800
    • Recruiting
    • Baruch Padeh MC
  • Tel Aviv, Israel, 69710
    • Recruiting
    • Assuta MC
• Japan
  • Bunkyō City, Japan, 113 8677
    • Recruiting
    • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  • Chiba, Japan, 260 0801
    • Recruiting
    • Chiba Cancer Center
  • Kamakura-shi, Japan, 247-8533
    • Recruiting
    • Shonan Kamakura General Hospital
  • Kamogawa, Japan, 296-8602
    • Recruiting
    • Kameda Medical Center
  • Kofu, Japan, 400-0027
    • Recruiting
    • Yamanashi Prefectural Central Hospital
  • Minato, Japan, 105-8471
    • Recruiting
    • The Jikei University Hospital
  • Shibuya City, Japan, 150-8935
    • Recruiting
    • Japanese Red Cross Medical Center
  • Yokohama, Japan, 241 8515
    • Recruiting
    • Kanagawa Cancer Center
• United Kingdom
  • Canterbury, United Kingdom, CT1 3NG
    • Recruiting
    • Kent and Canterbury Hospital
  • Dundee, United Kingdom, DD1 9SY
    • Recruiting
    • Ninewells Hospital & Medical School
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC Norris Comprehensive Cancer Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • University of Connecticut Health Center
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • Florida Cancer Specialists & Research Institute
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffit Cancer center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospital and Clinics
    • Waukee, Iowa, United States, 50263
      • Recruiting
      • Mission Cancer Blood
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Norton Cancer Institute
  • New York
    • Brooklyn, New York, United States, 11234
      • Recruiting
      • Mount Sinai Brooklyn
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10011
      • Recruiting
      • Mount Sinai Chelsea
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Durham VAMC
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-79635322; Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.	Drug: JNJ-79635322; JNJ-79635322 will be administered as SC injection.
Active Comparator: Anti BCMAxCD3 Bispecific Antibody; Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.	Drug: Teclistamab; Teclistamab will be administered as SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very Good Partial Response (VGPR) or Better	VGPR or better is defined as the percentage of participants achieving VGPR, complete response (CR), or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.	Up to 5 years and 4 months
Complete Response (CR) or Better	CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.	Up to 5 years and 4 months
Duration of Response (DoR)	DoR is defined as the time interval between the date of initial documentation of a response (partial response [PR] or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first.	Up to 5 years and 4 months
Minimal Residual Disease (MRD)-negative CR	MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy and who achieve CR or better.	Up to 5 years and 4 months
MRD-negative CR at 9 months	MRD-negative CR at 9 months is defined as the participants who achieve MRD-negative status at 9 months, as determined by NGF prior to PD or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria.	9 months
Sustained MRD-negative CR	Sustained MRD-negative CR is defined as participants with confirmed CR or better who sustain MRD-negative status, as determined by NGF, for at least 12 months without any examination showing MRD-positive status or progressive disease in between.	Up to 5 years and 4 months
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)	PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up.	Up to 5 years and 4 months
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.	Up to 5 years and 4 months
Time To Next Line of Therapy (TTNT)	TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.	Up to 5 years and 4 months
Number of Participants with Abnormalities in Clinical Laboratories Results	Number of participants with abnormalities in clinical laboratories results (serum chemistry and hematology) will be reported.	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	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 will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM.	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	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 will be reported.	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	The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.	Baseline up to 5 years and 4 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score	Time to worsening in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.	Up to 5 years and 4 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score	Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.	Up to 5 years and 4 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score	The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.	Up to 5 years and 4 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score	The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. It is included to be complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale.	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	Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.	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	The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.	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)	Percentage of participants with side effects burden on the EORTC IL46 will be reported. The EORTC IL46 measures the global impression of burden due to treatment-related symptoms.	Up to 5 years and 4 months
Serum Concentrations for JNJ-79635322	Serum concentrations of JNJ-79635322 will be reported.	Up to 5 years and 4 months
Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322	Serum samples will be analyzed for the detection of ADA to JNJ-79635322 using a validated assay method.	Up to 5 years and 4 months
Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322	Number of participants who are ADA-positive will be assessed for the presence of NAbs.	Up to 5 years and 4 months
Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, to Grade 5= death related to adverse event.	Up to 5 years and 4 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): December 12, 2028
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: 79635322MMY3001 (Other Identifier: Janssen Research & Development, LLC); 2025-522007-18-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No