Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT03399799
Trial Phases:	Phase I	Protocol IDs:	CR108404 (primary) NCI-2018-00367 64407564MMY1001 2017-002400-26
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT03399799

Summary

The purpose of this study is to characterize the safety of Talquetamab and to determine
the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for
Talquetamab (Part 1 [Dose Escalation]) and to further characterize the safety of
Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).

Objectives

The study will be conducted in 2 parts: dose escalation and dose expansion. The study
will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity
of Talquetamab administered to adult participants with relapsed or refractory multiple
myeloma. The overall safety of the study drug will be assessed by physical examinations,
Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs,
electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease
evaluations will include peripheral blood and bone marrow assessments at screening
(performed within 28 days) and to confirm stringent complete response (sCR), complete
response (CR), or relapse from CR. The end of study (study completion) is defined as the
last study assessment for the last participant in the study. Study record NCT04634552 is
Phase 2 part of this study and study record NCT03399799 is Phase 1 part of this study.

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