Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

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

Keywords

Multiple Myeloma, JNJ-79635322, Teclistamab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care accepting new patients
    Irvine California 92612 United States
  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT07518186
Phase
Phase 3 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 700 study participants
Last Updated