EP-SOGO Co., Ltd. | Nagoya City University Hospital
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
Full description
Teclistamab is a novel B-cell maturation antigen (BCMA) bispecific antibody that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. The primary hypothesis of this study is that Tec-Dara will significantly improve progression free survival (PFS) compared with investigator's choice of DPd/DVd in participants with relapsed refractory multiple myeloma. Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B). The study will be conducted in 3 phases: Screening Phase, Treatment Phase, and Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study. Disease evaluation will occur every cycle. Safety will be assessed throughout the study. Efficacy will be assessed using International Myeloma Working Group (IMWG) criteria. The overall duration of the study will be approximately 5 years.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:
Received any prior B cell maturation antigen (BCMA)-directed therapy
Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization
Received a live, attenuated vaccine within 4 weeks before randomization
Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
Primary purpose
Allocation
Interventional model
Masking
587 participants in 2 patient groups
Loading...
Central trial contact
Study Contact
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal