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

Active:	No
Cancer Type:	Multiple Myeloma	NCT ID:	NCT05083169
Trial Phases:	Phase III	Protocol IDs:	CR109049 (primary) NCI-2022-00768 2020-004742-11 64007957MMY3001
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT05083169

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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