ClinicalTrials.gg
RecruitingNCT07518186TRIlogy-5Updated Sep 25, 2026

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

A Phase 3 interventional study of JNJ-79635322 and Teclistamab in Multiple Myeloma, sponsored by Janssen Research & Development, LLC. Recruiting at 173 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Sep 25, 2026First site in Canada24 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 126 studies in Multiple Myeloma by Johnson & Johnson — 13 open to participants now, 33 under way, 12 of them phase 3. Multiple Myeloma · Johnson & Johnson.

Planned enrollment
9th of 100
700 · median 125
Started
2026
with 5 others
Phase 3
35 of 126
5 open now
Primary completion
2029-04
later than 26 of 32 live
Registered
123rd of 126
by date

Among the 126 studies in Multiple Myeloma by Johnson & Johnson, this one is the 9th largest by planned enrollment of the 100 interventional ones that give a count, is one of 6 that started in 2026, is one of 35 in phase 3, reaches primary completion later than 26 of the 32 other live ones, and was the 123rd registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 772 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

13 of the 126 studies in Multiple Myeloma by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 126 studies in Multiple Myeloma by Johnson & Johnson, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Multiple Myeloma

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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 (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

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, , intolerance or other to the use of JNJ-79635322 or teclistamab or their
  • Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell (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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
700 participants (estimated)

Study arms

  • 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

  • Active comparator
    Arm B: Teclistamab

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

    Drug: Teclistamab

Interventions

  • JNJ-79635322 will be administered as SC injection.

  • Teclistamab will be administered as SC injection.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 41 months

  2. 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.

    Time frame: Up to approximately 41 months

Secondary outcomes

  1. Overall Response Rate (ORR)

    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.

    Time frame: Up to approximately 41 months

  2. Very Good Partial Response (VGPR) or Better

    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.

    Time frame: Up to approximately 41 months

  3. Duration of Response (DoR)

    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.

    Time frame: Up to approximately 41 months

  4. Minimal Residual Disease (MRD)-negative CR

    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.

    Time frame: Up to approximately 41 months

  5. MRD-negative CR 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.

    Time frame: At 1 Year

  6. MRD-negative CR 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.

    Time frame: At 5 Years

  7. 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.

    Time frame: Up to approximately 41 months

  8. 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.

    Time frame: Up to approximately 41 months

  9. 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.

    Time frame: Up to approximately 41 months

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

    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.

    Time frame: Up to approximately 41 months

  11. Number of Participants with Abnormalities in Laboratory Parameters

    Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported.

    Time frame: Up to approximately 41 months

  12. 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

    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.

    Time frame: From Baseline up to approximately 41 months

  13. 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

    Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

    Time frame: From Baseline up to approximately 41 months

  14. Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores

    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.

    Time frame: From Baseline up to approximately 41 months

  15. Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores

    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.

    Time frame: Up to approximately 41 months

  16. Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores

    Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported.

    Time frame: Up to approximately 41 months

  17. Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores

    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.

    Time frame: Up to approximately 41 months

  18. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores

    The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.

    Time frame: Up to approximately 41 months

  19. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores

    Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

    Time frame: Up to approximately 41 months

  20. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores

    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.

    Time frame: Up to approximately 41 months

  21. Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46

    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.

    Time frame: Up to approximately 41 months

07

Study locations

173 of 173 sites recruiting

Showing the first 100 of 173 sites across 18 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: 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

Data sharing details ↗ · innovativemedicine.jnj.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Apr 2029, 34 months after the start.

Of 107 industry-sponsored phase 3 interventional studies under Multiple Myeloma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 66. This study's planned 34 months is below that.

Counting every sponsor, half of 178 studies reached it within 55 months; a quarter within 34 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2026
First posted
Apr 8, 2026
StartActual
May 31, 2026
Primary completionEst.
Apr 29, 2029
CompletionEst.
Dec 8, 2032
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
24 sites added, 2 sites removed — first site in Canada
Show 24 added (6 United States, 6 China, 4 Canada, 2 Australia, 2 Brazil, 2 France, 1 Italy, 1 Turkey (Türkiye))
  • Johns Hopkins Hospital · Baltimore, United States
  • Tufts Medical Center · Boston, United States
  • Duke University Medical Center · Durham, United States
  • Willamette Valley Cancer Institute and Research Center · Eugene, United States
  • Tennessee Oncology, PLLC · Nashville, United States
  • NorthWest Medical Specialties, PLLC · Tacoma, United States
  • Canberra Hospital · Garran, Australia
  • Royal Perth Hospital · Perth, Australia
  • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia · Brasília, Brazil
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) · Rio de Janeiro, Brazil
  • Arthur J E Child Comprehensive Cancer Centre · Calgary, Canada
  • Cross Cancer Institute · Edmonton, Canada
  • Lakeridge Health Oshawa · Oshawa, Canada
  • Princess Margaret Hospital · Toronto, Canada
  • Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital · Chengdu, China
  • The First Affiliated Hospital Zhejiang University College of Medicine · Hangzhou, China
  • The First Affiliated Hospital of NanChang University · Nanchang, China
  • Nanjing Drum Tower Hospital · Nanjing, China
  • Shanghai Fourth People s Hospital · Shanghai, China
  • Wuhan Tongji Hospital Tongji Medical College · Wuhan, China
  • Hospices Civils de Lyon HCL · Lyon, France
  • CHU Poitiers - Hopital la Miletrie · Poitiers, France
  • Ospedale S. Spirito, Azienda Sanitaria Pescara · Pescara, Italy
  • Gulhane Egitim ve Arastirma Hastanesi · Ankara, Turkey (Türkiye)
Show 2 removed
  • Sichuan Academy of Medical Science Sichuan Provincial People's Hospital · Chengdu, China
  • The First Affliated Hospital Of Nanchang University · Nanchang, China
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    24 sites added, 2 sites removed — first site in Canada
    Show 24 added (6 United States, 6 China, 4 Canada, 2 Australia, 2 Brazil, 2 France, 1 Italy, 1 Turkey (Türkiye))
    • Johns Hopkins Hospital · Baltimore, United States
    • Tufts Medical Center · Boston, United States
    • Duke University Medical Center · Durham, United States
    • Willamette Valley Cancer Institute and Research Center · Eugene, United States
    • Tennessee Oncology, PLLC · Nashville, United States
    • NorthWest Medical Specialties, PLLC · Tacoma, United States
    • Canberra Hospital · Garran, Australia
    • Royal Perth Hospital · Perth, Australia
    • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia · Brasília, Brazil
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) · Rio de Janeiro, Brazil
    • Arthur J E Child Comprehensive Cancer Centre · Calgary, Canada
    • Cross Cancer Institute · Edmonton, Canada
    • Lakeridge Health Oshawa · Oshawa, Canada
    • Princess Margaret Hospital · Toronto, Canada
    • Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital · Chengdu, China
    • The First Affiliated Hospital Zhejiang University College of Medicine · Hangzhou, China
    • The First Affiliated Hospital of NanChang University · Nanchang, China
    • Nanjing Drum Tower Hospital · Nanjing, China
    • Shanghai Fourth People s Hospital · Shanghai, China
    • Wuhan Tongji Hospital Tongji Medical College · Wuhan, China
    • Hospices Civils de Lyon HCL · Lyon, France
    • CHU Poitiers - Hopital la Miletrie · Poitiers, France
    • Ospedale S. Spirito, Azienda Sanitaria Pescara · Pescara, Italy
    • Gulhane Egitim ve Arastirma Hastanesi · Ankara, Turkey (Türkiye)
    Show 2 removed
    • Sichuan Academy of Medical Science Sichuan Provincial People's Hospital · Chengdu, China
    • The First Affliated Hospital Of Nanchang University · Nanchang, China
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07518186
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
May 31, 2026
Primary completion
Apr 29, 2029 (estimated)
Completion
Dec 8, 2032 (estimated)
Last update
Sep 25, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ramantamig

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