Last updated on February 2020

Dose Escalation Study of JNJ-64007957 a Humanized BCMA CD3 DuoBody Antibody in Participants With Relapsed or Refractory Multiple Myeloma


Brief description of study

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for JNJ-64007957 and to characterize the safety and tolerability of JNJ-64007957 at the RP2Ds.

Detailed Study Description

The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64007957 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 on study.

Clinical Study Identifier: NCT03145181

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VU Medisch Centrum

Amsterdam, Netherlands
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