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

Last updated: May 22, 2025
Sponsor: Janssen Pharmaceutical K.K.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Bone Neoplasm

Multiple Myeloma

Lymphoproliferative Disorders

Treatment

Talquetamab

Clinical Study ID

NCT04773522
CR108930
64407564MMY1003
  • Ages > 20
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma according to International Myeloma WorkingGroup (IMWG) diagnostic criteria

  • Participants must be relapsed or refractory to established therapies with knownclinical benefit in relapsed/refractory multiple myeloma (MM) or be intolerant ofthose established MM therapies, and a candidate for talquetamab treatment in theopinion of the treating physician. Prior lines of therapy must include a proteasomeinhibitor (PI), an immunomodulatory drug (IMiD) and an anti-CD38 antibody in anyorder during the course of treatment. Participants who could not tolerate a PI,immunomodulatory drugs or anti-CD38 antibody are allowed

  • Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1 atscreening and immediately before the start of study treatment administration

  • Women of childbearing potential must have a negative pregnancy test at screening andwithin 24 hours prior to the first dose of study treatment using highly sensitivepregnancy test either serum (Beta-human chorionic gonadotropin [Beta-hCG]) or urine

  • Participants (or a legally acceptable representative) must sign an informed consentform (ICF) indicating that he or she understands the purpose of, and proceduresrequired for, the study and is willing to participate in the study. Consent is to beobtained prior to the initiation of any study-related tests or procedures that arenot part of standard-of-care for the participant's disease

Exclusion

Exclusion Criteria:

  • Toxicities from previous anticancer therapies that have not resolved to baselinelevels or to Grade 1 or less except for alopecia or peripheral neuropathy

  • Received a cumulative dose of corticosteroids equivalent to >=140 milligrams (mg) ofprednisone within the 14-day period before the first step-up dose of study treatment (does not include pretreatment medication)

  • Central nervous system involvement or clinical signs of meningeal involvement ofmultiple myeloma. If either is suspected, whole brain magnetic resonance imaging (MRI) and lumbar cytology are required during screening

  • Pulmonary compromise requiring supplemental oxygen use to maintain adequateoxygenation

  • Known allergies, hypersensitivity, or intolerance to the excipients of talquetamab

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Talquetamab
Phase: 1
Study Start date:
May 20, 2021
Estimated Completion Date:
August 14, 2025

Connect with a study center

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, 277 8577
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, 467 8602
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Shibuya, 150-8935
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695
    Japan

    Site Not Available

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