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

  • STATUS
    Recruiting
  • End date
    Jan 9, 2023
  • participants needed
    9
  • sponsor
    Janssen Pharmaceutical K.K.
Updated on 16 May 2022
human chorionic gonadotropin
refractory multiple myeloma

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.

Details
Condition Multiple Myeloma
Treatment Talquetamab
Clinical Study IdentifierNCT04773522
SponsorJanssen Pharmaceutical K.K.
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Participants must be relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma (MM) or be intolerant of those established MM therapies, and a candidate for talquetamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) and an anti-CD38 antibody in any order 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 at screening and immediately before the start of study treatment administration
Women of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study treatment using highly sensitive pregnancy test either serum (Beta-human chorionic gonadotropin [Beta-hCG]) or urine
Participants (or a legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

Exclusion Criteria

Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
Received a cumulative dose of corticosteroids equivalent to >=140 milligrams (mg) of prednisone 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 of multiple 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 adequate oxygenation
Known allergies, hypersensitivity, or intolerance to the excipients of talquetamab
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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