A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (TRIlogy-3)

Janssen (J&J Innovative Medicine)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: JNJ-79635322

Study type: Interventional

Funder types: Industry

Identifiers

NCT07266441

2025-521976-80-00 (Registry Identifier)

79635322MMY2001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 157 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient group

JNJ-79635322

Experimental group

Description:

Participants will receive JNJ-79635322 as an injection under the skin.

Treatment:

Drug: JNJ-79635322