A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04773522
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talquetamab — DRUG
    Talquetamab will be administered subcutaneously.

Study Details

The purpose of this study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (MM) at the recommended Phase 2 dose (RP2D) identified in NCT03399799 study.

Key Dates

Start date
May 20, 2021
Status verified
Sep 2025
Primary completion
Oct 14, 2022
Completion
Sep 4, 2025

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Talquetamab
    Participants will receive talquetamab injection subcutaneously (SC) in 3 cohorts: Cohort 1 and Cohort 2 as 2 step-up doses and Cohort 3 as 3 step-up doses followed by a treatment dose.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 1.5 years ]

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