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 (TRIlogy-3)

未提供0 个研究点目标入组 157 人开始时间: 待定

适应症

试验速览

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•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 at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anticluster 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

•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

发起方

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