A Phase 2, Open-label Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody.
Primary:
To evaluate the efficacy of JNJ-79635322
Secondary:
- To further understand the efficacy of JNJ-79635322
- To evaluate and characterize the overall safety profile of JNJ-79635322
- To assess participants symptoms, functioning and HRQoL through PROs
- To characterize the PK of JNJ-79635322
- To assess the immunogenicity of JNJ-79635322
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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