RecruitingPhase 3NCT07518186
A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
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
Sponsor
Janssen Research & Development, LLC
Enrollment
700 participants
Start Date
May 31, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGJNJ-79635322
JNJ-79635322 will be administered as SC injection.
DRUGTeclistamab
Teclistamab will be administered as SC injection.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07518186
Related Trials
Tissue Collection for Studies of Lymph Cancer
NCT016768052 locations
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
NCT06152575273 locations
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
NCT0605740233 locations
A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
NCT074543827 locations
64Cu-LLP2A for Imaging Hematologic Malignancies
NCT066361751 location