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Multiple MyelomaPhase 2TRIlogy-3NCT07266441

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing JNJ-79635322 in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 71 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
JNJ-79635322
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
71 sitesin 8 countries
Study dates
8 Feb 2026to 12 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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

Who cannot join

  • 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

Trial locations and contacts

71 sites in 8 countries.

71 sites in 8 countries

United States30 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital Cancer Institute

    Atlanta, Georgia, 30342

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Texas Oncology

    Austin, Texas, 78705

  • O Neal Comprehensive Cancer Center at UAB

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Cleveland Clinic Foundtation

    Cleveland, Ohio, 44195

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope

    Duarte, California, 91010

  • Oncology Associates of Oregon PC Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Oncology Consultants Texas

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Cancer Care Specialists of Central Illinois

    O'Fallon, Illinois, 62269

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of California San Francisco

    San Francisco, California, 94143

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Texas Oncology - Northeast

    Tyler, Texas, 75702

  • Mission Cancer Blood

    Waukee, Iowa, 50263

Other trials in United States

Italy9 sites

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera S Croce e Carle Cuneo

    Cuneo, 12100

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100

  • Presidio Ospedaliero Pescara

    Pescara, 65124

  • AOU Policlinico Umberto I

    Roma, 00161

  • Centro Ricerche Cliniche di Verona S r l

    Verona, 37134

Other trials in Italy

Poland8 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozów, 36 200

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30 688

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 513

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20 081

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

  • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

    Torun, 87 100

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367

Other trials in Poland

Israel6 sites

  • Ha'Emek Medical Center

    Afula, 1834111

  • Samson Assuta Ashdod University Hospital

    Ashdod, 7747629

  • Hillel Yaffe Medical Center

    Hadera, 3820302

  • Hadassah Medical Center

    Jerusalem, 9112000

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

South Korea6 sites

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Turkey (Türkiye)6 sites

  • Ankara University Medical Faculty

    Ankara, 06590

  • Liv Hospital Ankara

    Ankara, 06680

  • Memorial Antalya Hospital

    Antalya, 07025

  • Medipol University Hospital

    Istanbul, 34214

  • Istanbul Florance Nightingale Hospital

    Istanbul, 34381

  • Sakarya Üniversitesi Tıp Fakültesi Hastanesi

    Sakarya, 54050

Other trials in Turkey (Türkiye)

China4 sites

  • Peking Union Medical College Hospital

    Beijing, 100006

  • Beijing Chaoyang Hospital

    Chaoyang District, 100020

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510700

  • Shanghai Fourth People s Hospital

    Shanghai, 200434

Other trials in China

Japan2 sites

  • National Hospital Organization Shibukawa Medical Center

    Gunma, 377-0280

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

Other trials in Japan

About this study

Official title: 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

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.

Being tested
JNJ-79635322
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-79635322Drug

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

Study groups in NCT07266441
Study groupRoleWhat they receive
JNJ-79635322ExperimentalParticipants will receive JNJ-79635322 as an injection under the skin.
Receives: Drug: JNJ-79635322

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    Measured: Up to 2 years and 9 months

Secondary outcomes (19)

  1. Very Good Partial Response (VGPR) or Better Rate

    Measured: Up to 2 years and 9 months

  2. Complete Response (CR) or Better Rate

    Measured: Up to 2 years and 9 months

  3. Duration of Response (DoR)

    Measured: Up to 2 years and 9 months

  4. Progression-Free Survival (PFS)

    Measured: Up to 2 years and 9 months

  5. Overall Survival (OS)

    Measured: Up to 2 years and 9 months

  6. Time To Next Line of Therapy (TTNT)

    Measured: Up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

  8. 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

    Measured: From Baseline up to 2 years and 9 months

  9. 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

    Measured: From Baseline up to 2 years and 9 months

  10. 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

    Measured: From Baseline up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

  17. Serum Concentrations for JNJ-79635322

    Measured: Up to 2 years and 9 months

  18. Number of Participants With Anti JNJ-79635322 Antibodies

    Measured: Up to 2 years and 9 months

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

    Measured: Up to 2 years and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start8 Feb 2026
  3. Primary completion14 Jun 2027 (estimated)
  4. Study completion12 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07266441
Sponsor's protocol ID
79635322MMY2001
Other IDs
79635322MMY2001, 2025-521976-80-00, 2025
Acronym
TRIlogy-3
Status last verified
Nov 2026
First submitted
25 Nov 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-79635322 in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 71 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Italy, Poland, Israel, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 2 years and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07266441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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