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

RECRUITINGPhase 3Sponsored by Janssen Research & Development, LLC
Actively Recruiting
PhasePhase 3
SponsorJanssen Research & Development, LLC
Started2026-05-31
Est. completion2029-04-29
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations11 sites

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerMultiple Myeloma

Interventions2

Locations11 sites

Highlands Oncology Group
Springdale, Arkansas, 72762
Valkyrie Clinical Trials
Emory University
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Astera Cancer Care
East Brunswick, New Jersey, 08816

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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