A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma
The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.
• Patient must be at least ≥65 years of age at the time of informed consent with documented multiple myeloma as defined by the criteria below:
• Multiple myeloma diagnosis according to IMWG diagnostic criteria
• Measurable disease at Screening as defined by any of the following:
• Serum monoclonal paraprotein (M-protein) level ³ 0.5 g/dL; or Urine M protein level ³ 200 mg/24 hours; or Serum Ig FLC ³ 10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio
• Have an ECOG performance status score of 0-2
• Not considered for high-dose chemotherapy and autologous SCT
• Have clinical laboratory values meeting the criteria during the Screening Phase.
• A male patient must wear a condom (with spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a period of 3 months after the last dose of other study treatments, whichever occurs later. If the male patient's partner is a female of childbearing potential, she must also be practicing a highly effective method of contraception. If the male patient is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception.
⁃ 7\. A male patient must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for period of 3 months after receiving the last dose of other study treatments, whichever occurs later.
⁃ 8\. Must sign an ICF (or their legally acceptable representative must sign in accordance with local requirements) indicating that the patient understands the purpose of, and procedures required for, the study and is willing to participate in the study.
⁃ 9\. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.