A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT04634552
Trial Phases:	Phase II	Protocol IDs:	CR108920 (primary) NCI-2021-02134 2017-002400-26 2023-504581-29-00 TALMMY1001-PT3
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT04634552

Summary

The purpose of this study is to evaluate the efficacy and safety of talquetamab in
participants with relapsed or refractory multiple myeloma at the recommended Phase 2
dose(s) (RP2Ds) (Part 3).

Objectives

Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions,
increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is
a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody
designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the
CD3 molecule found on T lymphocytes (T cell). 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 (30 days (+ 7 days)] visit); and a
post-treatment follow-up phase (until the end of study unless the participant has died,
is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years
(after the last participant receives their first dose). Safety, pharmacokinetics (PK),
laboratory tests, and questionnaire will be assessed at specified time points during this
study. Participants safety and study conduct will be monitored throughout the study. The
corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3
is the Phase 2 part of the study.

Treatment Sites in Georgia

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

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