Recruiting NCT07258511

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

Phase III Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: JNJ-79635322, Teclistamab.
Who it may be relevant to: Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Canada, China, France +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Overview

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Interventions

Drug JNJ-79635322
JNJ-79635322 will be administered as SC injection.
Drug Teclistamab
Teclistamab will be administered as SC injection.

Primary outcome measures

Overall Response [Time frame: Up to 5 years and 7 months]
Progression-Free Survival (PFS) [Time frame: Up to 5 years and 7 months]

Secondary outcome measures (12)

Very Good Partial Response (VGPR) or Better [Time frame: Up to 5 years and 7 months]
Complete Response (CR) or Better [Time frame: Up to 5 years and 7 months]
Duration of Response (DoR) [Time frame: Up to 5 years and 7 months]
Minimal Residual Disease (MRD)-negative CR [Time frame: Up to 5 years and 7 months]
MRD-Negative CR at 12 months [Time frame: 12 months]
Sustained MRD-negative CR [Time frame: Up to 5 years and 7 months]
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2) [Time frame: Up to 5 years and 7 months]
Overall Survival (OS) [Time frame: Up to 5 years and 7 months]
Time to Subsequent Anti-Myeloma Therapy [Time frame: Up to 5 years and 7 months]
Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity [Time frame: Up to 5 years and 7 months]
Number of Participants with Abnormalities in Clinical Laboratories Results [Time frame: Up to 5 years and 7 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) Score [Time frame: Baseline up to 5 years and 7 months]

Eligibility criteria

Inclusion:

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 antibody
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 IMWG criteria
Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

Active hepatitis of infectious origin
Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
Major surgery, (example, requiring general anesthesia) within 2 weeks before 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
Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment