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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07266441
Acronym
TRIlogy-3
Enrollment
157
Registered
2025-12-05
Start date
2026-02-08
Completion date
2028-12-12
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief 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. 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.

Interventions

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

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 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 Exclusion: * 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

Design outcomes

Primary

MeasureTime frame
Overall Response Rate (ORR)Up to 2 years and 9 months

Secondary

MeasureTime frame
Very Good Partial Response (VGPR) or Better RateUp to 2 years and 9 months
Complete Response (CR) or Better RateUp to 2 years and 9 months
Duration of Response (DoR)Up to 2 years and 9 months
Progression-Free Survival (PFS)Up to 2 years and 9 months
Overall Survival (OS)Up to 2 years and 9 months
Time To Next Line of Therapy (TTNT)Up to 2 years and 9 months
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by SeverityUp to 2 years and 9 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) Scale ScoreFrom Baseline up to 2 years and 9 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) Scale ScoreFrom Baseline up to 2 years and 9 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale ScoreFrom Baseline up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-QUp to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30Up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5LUp to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-QUp to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30Up to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5LUp to 2 years and 9 months
Serum Concentrations for JNJ-79635322Up to 2 years and 9 months
Number of Participants With Anti JNJ-79635322 AntibodiesUp to 2 years and 9 months
Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb)Up to 2 years and 9 months

Countries

Israel, Japan, United States

Contacts

CONTACTStudy Contact
Participate-In-This-Study1@its.jnj.com844-434-4210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026