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
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
Other Locations
Israel
Carmel Medical Center
RECRUITING
Haifa
Rambam Med.Center - Hematology Institute
RECRUITING
Haifa
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Medipol Mega University Hospital
RECRUITING
Istanbul
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2026-05-31
Estimated Completion Date:2032-12-08
Participants
Target number of participants:700
Treatments
Experimental: Arm A: JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).
Active_comparator: Arm B: Teclistamab
Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.