Last updated on November 2019

Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma


Brief description of study

The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).

Detailed Study Description

The study will be conducted in 2 parts, separately for intravenous (IV) and subcutaneous (SC) administration: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 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.

Clinical Study Identifier: NCT03399799

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VU Medisch Centrum

Amsterdam, Netherlands
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