Clinical Trials /

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

NCT04773522

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
  • Official Title: A Phase 1 Study of JNJ-64407564, a Humanized GPRC5D * CD3 Bispecific Antibody in Japanese Subjects With Relapsed or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CR108930
  • SECONDARY ID: 64407564MMY1003
  • NCT ID: NCT04773522

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
TalquetamabJNJ-64407564Talquetamab

Purpose

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.

Trial Arms

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

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Adverse Events (AEs)
Time Frame:Up to 1.5 years
Safety Issue:
Description:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

Secondary Outcome Measures

Measure:Serum Concentrations of JNJ-64407564
Time Frame:Up to 1.5 years
Safety Issue:
Description:Serum concentrations of JNJ-64407564 will be assessed.
Measure:Systemic Cytokine Concentrations
Time Frame:Up to 1.5 years
Safety Issue:
Description:Cytokine concentrations such as concentration of interleukin (IL)-6, Interferon (IFN)-gamma, IL-10 and IL-2 receptors will be measured for biomarker assessment.
Measure:Number of Participants With Anti-Talquetamab Antibodies
Time Frame:Up to 1.5 years
Safety Issue:
Description:Number of participants with anti-talquetamab antibodies will be reported for immunogenicity assessment.
Measure:Number of Participants With Objective Response
Time Frame:Up to 1.5 years
Safety Issue:
Description:Objective response is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Measure:Duration of Response (DOR)
Time Frame:Up to 1.5 years
Safety Issue:
Description:DOR is defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death.
Measure:Time to Response (TTR)
Time Frame:Up to 1.5 years
Safety Issue:
Description:TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation that the participant has met all criteria for PR or better.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Janssen Pharmaceutical K.K.

Last Updated

March 30, 2021