A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (TRIlogy-5)

August 27, 2026 updated by: Janssen Research & Development, LLC

A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Darlinghurst, Australia, 2010
        • Recruiting
        • St Vincent s Hospital Sydney
      • Heidelberg, Australia, 3084
        • Recruiting
        • Austin Hospital
      • Macquarie University, Australia, 2109
        • Recruiting
        • Macquarie University Hospital
      • Melbourne, Australia, 3128
        • Recruiting
        • Box Hill Hospital
      • Port Macquarie, Australia, 2444
        • Recruiting
        • Port Macquarie Base Hospital
  • Brazil
      • Curitiba, Brazil, 81520-060
        • Recruiting
        • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
      • Florianópolis, Brazil, 88020 210
        • Recruiting
        • Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
      • Joinville, Brazil, 89201-260
        • Recruiting
        • Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
      • Porto Alegre, Brazil, 90050 170
        • Recruiting
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • Funfarme Sjrp
      • São Paulo, Brazil, 01323 001
        • Recruiting
        • Real e Benemerita Associacao Portuguesa de Beneficencia
      • São Paulo, Brazil, 05651 901
        • Recruiting
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • São Paulo, Brazil, 04537 081
        • Recruiting
        • Clinica Medica Sao Germano LTDA
  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
      • Beijing, China, 100006
        • Recruiting
        • Peking Union Medical College Hospital
      • Changchun, China, 130061
        • Recruiting
        • The First Hospital of Jilin University
      • Chaoyang District, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Academy of Medical Science Sichuan Provincial People's Hospital
      • Guangzhou, China, 510710
        • Recruiting
        • Sun Yat Sen University Cancer Center
      • Nanchang, China, 330006
        • Recruiting
        • The First Affliated Hospital Of Nanchang University
      • Shenzhen, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
      • Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
      • Tijian, China, 300020
        • Recruiting
        • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
      • Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
      • Xi'an, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • Fakultni nemocnice Brno
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • FN Hradec Kralove
      • Ostrava, Czechia, 708 52
        • Recruiting
        • Fakultni Nemocnice Ostrava
      • Plzen-Lochotin, Czechia, 323 00
        • Recruiting
        • FN Plzen
      • Prague, Czechia, 128 08
        • Recruiting
        • VFN Praha
  • France
      • Amiens, France, 80000
        • Recruiting
        • CHU Amiens
      • Montpellier, France, 34295
        • Recruiting
        • CHRU Montpellier - Hopital Saint-Eloi
      • Nantes, France, 44000
        • Recruiting
        • CHU Nantes - Hôtel Dieu
      • Talence, France, 33400
        • Recruiting
        • CHU Bordeaux
      • Toulouse, France, 31300
        • Recruiting
        • CHU Toulouse
      • Tours, France, 37000
        • Recruiting
        • CHRU de Tours
  • Germany
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
      • Hamburg, Germany, 20251
        • Recruiting
        • Universitaetsklinikum Hamburg Eppendorf
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitaetsklinik Tuebingen
  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • Alexandra General Hospital of Athens
      • Athens, Greece, 106 76
        • Recruiting
        • Evangelismos S A
      • Athens, Greece, 124 62
        • Recruiting
        • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
      • Ioannina, Greece, 455 00Q
        • Recruiting
        • University General Hospital Of Ioannina
  • India
      • Bengaluru, India, 560054
        • Recruiting
        • M S Ramaiah Medical College and Hospital
      • Gurgaon, India, 122002
        • Recruiting
        • Fortis Memorial Research Institute
      • Jaipur, India, 302017
        • Recruiting
        • Bhagwan Mahaveer Cancer Hospital & Research Centre
      • Kolkata, India, 700156
        • Recruiting
        • Tata Medical Center
      • Kolkata, India, 700014
        • Recruiting
        • Nil Ratan Sircar Medical College and Hospital
      • New Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute And Research Centre
      • Pune, India, 411004
        • Recruiting
        • Deenanath Mangeshkar Hospital and Research Centre
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Samson Assuta Ashdod University Hospital
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Medical Center
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Med.Center - Hematology Institute
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Israel, 5266202
        • Recruiting
        • Sheba medical center
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Irccs Istituto Tumori Giovanni Paolo Ii
      • Bologna, Italy, 40138
        • Recruiting
        • A O U Sant Orsola Malpighi
      • Bolzano, Italy, 39100
        • Recruiting
        • Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
      • Milan, Italy, 20153
        • Recruiting
        • Asst Santi Paolo E Carlo
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele di Milano
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
      • Palermo, Italy, 90146
        • Recruiting
        • Casa di Cura La Maddalena
      • Rimini, Italy, 47900
        • Recruiting
        • Ospedale Infermi Rimini
      • Varese, Italy, 21100
        • Recruiting
        • ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
  • Japan
      • Chiba, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center
      • Fukuoka, Japan, 810 8563
        • Recruiting
        • National Hospital Organization Kyushu Medical Center
      • Gunma, Japan, 371-0034
        • Recruiting
        • Gunma University Hospital
      • Kamakura-shi, Japan, 247-8533
        • Recruiting
        • Shonan Kamakura General Hospital
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital Kyoto Prefectural University of Medicine
      • Matsuyama, Japan, 790-8524
        • Recruiting
        • Matsuyama Red Cross Hospital
      • Okayama, Japan, 701-1192
        • Recruiting
        • National Hospital Organization Okayama Medical Center
      • Sapporo, Japan, 060-8604
        • Recruiting
        • Sapporo City General Hospital
      • Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital of JFCR
      • Yokohama, Japan, 241 8515
        • Recruiting
        • Kanagawa Cancer Center
  • Poland
      • Bydgoszcz, Poland, 85 168
        • Recruiting
        • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
      • Gdansk, Poland, 80 214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Katowice, Poland, 40 519
        • Recruiting
        • Pratia Onkologia Katowice
      • Lublin, Poland, 20 090
        • Recruiting
        • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
      • Warsaw, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by PRATIA
      • Wałbrzych, Poland, 58 309
        • Recruiting
        • Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu
  • South Korea
      • Goyang-si, South Korea, 10408
        • Recruiting
        • National Cancer Center
      • Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Hwasun, South Korea, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea Seoul St Marys Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hosp. Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Recruiting
        • Hosp Univ Vall D Hebron
      • Cáceres, Spain, 10003
        • Recruiting
        • Hosp. San Pedro de Alcantara
      • Córdoba, Spain, 14004
        • Recruiting
        • Hosp Reina Sofia
      • Jerez de la Frontera, Spain, 11407
        • Recruiting
        • Hosp. de Jerez de La Frontera
      • Madrid, Spain, 28041
        • Recruiting
        • Hosp. Univ. 12 de Octubre
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Univ. de Navarra
      • Salamanca, Spain, 37007
        • Recruiting
        • Hosp Clinico Univ de Salamanca
      • Santander, Spain, 39008
        • Recruiting
        • Hosp. Univ. Marques de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spain, 41013
        • Recruiting
        • Hosp. Virgen Del Rocio
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • Chang Kung Memorial Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06680
        • Recruiting
        • Liv Hospital Ankara
      • Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Ankara, Turkey (Türkiye), 06620
        • Recruiting
        • Ankara University Medical Faculty
      • Ankara, Turkey (Türkiye), 6170
        • Recruiting
        • Ankara Etlik Sehir Hastanesi
      • Antalya, Turkey (Türkiye), 07025
        • Recruiting
        • Memorial Antalya Hospital
      • Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Medipol Mega University Hospital
      • Istanbul, Turkey (Türkiye), 34381
        • Recruiting
        • Istanbul Florance Nightingale Hospital
      • Izmir, Turkey (Türkiye), 35001
        • Recruiting
        • Izmir Tinaztepe University Galen Hospital
      • Mersin, Turkey (Türkiye), 33110
        • Recruiting
        • Mersin University Medical Faculty
      • Samsun, Turkey (Türkiye), 55420
        • Recruiting
        • Ondokuz Mayis University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Recruiting
        • Alabama Oncology
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic 1
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Beverly Hills Cancer Center Clinical Research Advisors LLC
      • Irvine, California, United States, 92612
        • Recruiting
        • UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Valkyrie Clinical Trials
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • University of Connecticut Health Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
      • Pembroke Pines, Florida, United States, 33026
        • Recruiting
        • Memorial Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Rush University System for Health
    • Indiana
      • Indianapolis, Indiana, United States, 46237-8601
        • Recruiting
        • Franciscan Health
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • Mission Cancer Blood University of Iowa Health Care
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Feist Weiller Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Recruiting
        • CHRISTUS St. Vincent Regional Cancer Center
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • New York Oncology Hematology
      • Mineola, New York, United States, 11501
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health Manhattan
      • Shirley, New York, United States, 11967
        • Recruiting
        • New York Cancer and Blood Specialists
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center
      • Cincinnati, Ohio, United States, 45069
        • Recruiting
        • The Christ Hospital
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physicians Network Urology
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Bon Secours Saint Francis Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • Joe Arrington Cancer Research Treatment Center
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Recruiting
        • Utah Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).
Drug: JNJ-79635322
JNJ-79635322 will be administered as SC injection.
Active Comparator: Arm B: Teclistamab
Participants will receive teclistamab 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete Response (CR) or Better
Time Frame: Up to approximately 41 months
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)
Time Frame: Up to approximately 41 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to approximately 41 months
ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
Up to approximately 41 months
Very Good Partial Response (VGPR) or Better
Time Frame: Up to approximately 41 months
VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.
Up to approximately 41 months
Duration of Response (DoR)
Time Frame: Up to approximately 41 months
DoR is defined as the time interval between the date of initial documentation of a 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 approximately 41 months
Minimal Residual Disease (MRD)-negative CR
Time Frame: Up to approximately 41 months
MRD-negative CR is defined as the percentage of participants with CR or better 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.
Up to approximately 41 months
MRD-negative CR at 1 Year
Time Frame: At 1 Year
MRD-negative CR at 1 year is defined as the percentage of participants who achieve MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.
At 1 Year
MRD-negative CR at 5 Years
Time Frame: At 5 Years
MRD-negative CR at 5 years is defined as the percentage of participants who achieve MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.
At 5 Years
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)
Time Frame: Up to approximately 41 months
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 approximately 41 months
Overall Survival (OS)
Time Frame: Up to approximately 41 months
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 approximately 41 months
Time To Next Line of Therapy (TTNT)
Time Frame: Up to approximately 41 months
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 approximately 41 months
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Time Frame: Up to approximately 41 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. 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 will be considered treatment-related regardless of the start date of the event. 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, Grade 5= death related to adverse event.
Up to approximately 41 months
Number of Participants with Abnormalities in Laboratory Parameters
Time Frame: Up to approximately 41 months
Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported.
Up to approximately 41 months
Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores
Time Frame: From Baseline up to approximately 41 months
Change from baseline in HRQoL, symptoms and functioning as assessed by 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.
From Baseline up to approximately 41 months
Change from Baseline in HRQoL, Symptoms and Functioning Using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Scores
Time Frame: From Baseline up to approximately 41 months
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
From Baseline up to approximately 41 months
Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores
Time Frame: From Baseline up to approximately 41 months
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.
From Baseline up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Time Frame: Up to approximately 41 months
Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with RRMM and newly diagnosed MM.
Up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
Time Frame: Up to approximately 41 months
Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported.
Up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores
Time Frame: Up to approximately 41 months
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 approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Time Frame: Up to approximately 41 months
The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.
Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
Time Frame: Up to approximately 41 months
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores
Time Frame: Up to approximately 41 months
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 approximately 41 months
Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46
Time Frame: Up to approximately 41 months
The EORTC IL46 consists of one single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4-point scale.
Up to approximately 41 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 79635322MMY3002

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

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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