A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Active:	Yes
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT04586426
Trial Phases:	Phase I Phase II	Protocol IDs:	CR108901 (primary) NCI-2023-06901 2019-004124-38 2023-503439-16-00 64007957MMY1003
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT04586426

Summary

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and
schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for
the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab +
teclistamab in participants with relapsed or refractory multiple myeloma and
extramedullary disease (EMD) (Part 3).

Objectives

Multiple myeloma is a malignant plasma cell disorder characterized by production of
monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig)
or fragments of such, which have subsequently lost their normal function. Rationale for
combining talquetamab and teclistamab is the targeting of multiple proteins on the
surface of multiple myeloma cells resulting in cell lysis. This study consists of 3
periods: screening phase (up to 28 days), treatment phase (start of study drug
administration and continues until the completion of the end of treatment [EOT] visit);
and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after
last dose of study drug(s) for each participant). End of study is defined as 2 years
after the last participant has received his or her initial dose of the treatment
combination. Total duration of study is Approximately 5 years. Efficacy, safety,
pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time
points during this study. Participants safety and study conduct will be monitored
throughout the study.

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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