A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
18 Years and older, Male and Female
CR109049 (primary)
NCI-2022-00768
2020-004742-11
64007957MMY3001
Summary
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).
Objectives
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.
Eligibility
- Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the 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 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
- Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
- Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
- Have clinical laboratory values within the specified range
Treatment Sites in Georgia
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