A Study Comparing Teclistamab Monotherapy Vs Pomalidomide, Bortezomib, Dexamethasone or Carfilzomib, Dexamethasone in Participants with Relapsed or Refractory Multiple Myeloma
A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Djuro, Victor; Waris, Seema; Perry,Mary
Trial Phone: 321.841.9821 ; 321.841.7477 ; 321.841.1907 ; 321.841.2856
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IRB No: W23.119.06
Protocol Abbrev: MAJESTEC-9
Principal Investigator: Jose E. Sarriera, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: CR109244
Treatment: Drug: Teclistamab Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone Drug: Carfilzomib
ClinicalTrials.gov ID: NCT05572515
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Objective
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.
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Key Eligibility
Inclusion Criteria:
• Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
• Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
• Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
• A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
• Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
