RecruitingInterventionalPhase 3

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

NCT ID: NCT07518186Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

Summary

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

Arms & interventions

DrugJNJ-79635322
JNJ-79635322 will be administered as SC injection.
DrugTeclistamab
Teclistamab will be administered as SC injection.

Outcome measures

Primary

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
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

Overall Response Rate (ORR)
Time frame: Up to approximately 41 months
Very Good Partial Response (VGPR) or Better
Time frame: Up to approximately 41 months
Duration of Response (DoR)
Time frame: Up to approximately 41 months
Minimal Residual Disease (MRD)-negative CR
Time frame: Up to approximately 41 months
MRD-negative CR at 1 Year
Time frame: At 1 Year
MRD-negative CR at 5 Years
Time frame: At 5 Years
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)
Time frame: Up to approximately 41 months
Overall Survival (OS)
Time frame: Up to approximately 41 months
Time To Next Line of Therapy (TTNT)
Time frame: Up to approximately 41 months
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Time frame: Up to approximately 41 months
Number of Participants with Abnormalities in Laboratory Parameters
Time frame: 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 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 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
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 EORTC-QLQ-C30 Scale Scores
Time frame: 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
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Time frame: 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 HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores
Time frame: 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (2)

Highlands Oncology Group

Springdale, Arkansas, 72762

Recruiting

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting