Clinical Trial 23741

• Overview

  Study Title:

  A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy

  Summary:

  The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

  Objective:

  The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

• Inclusion Criteria

  Inclusion Criteria:
  • Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria.
  • Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
  • A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.
  • A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment.
  • Enrolling at Memorial Healthcare system only.

• Exclusion Criteria

  Exclusion Criteria:
  • Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization.
  • Had plasmapheresis within 28 days of randomization.
  • Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
  • Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients.
  • Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
  • Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone.
  • Enrolling at Memorial Healthcare system only.

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