A comparison of JNJ-79635322 and teclistamab in relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares the effectiveness of JNJ-79635322 versus teclistamab in adults with relapsed or refractory multiple myeloma. Eligible participants have measurable disease and have received 1 to 3 prior anti-myeloma therapies, including an anti-CD38 antibody and lenalidomide, with good performance status. The study uses central laboratory assessments to verify disease and applies standard safety monitoring throughout treatment. Primary endpoints typically include efficacy measures such as response rate and progression-free survival, along with safety profiling. Participants will be recruited at selected centers in Alabama, Arizona, and Arkansas under Janssen Research & Development oversight.

Why it matters

Who can join: the full rules

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

Where it's running

• Alabama Oncology
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic 1
  Phoenix, Arizona, United States Recruiting
• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• Beverly Hills Cancer Center Clinical Research Advisors LLC
  Beverly Hills, California, United States Recruiting
• UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care
  Irvine, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting

+123 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.