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

Sponsor
Janssen Pharmaceutical K.K. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04773522
Collaborator
(none)
9
Enrollment
4
Locations
1
Arm
15.9
Anticipated Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of JNJ-64407564, a Humanized GPRC5D * CD3 Bispecific Antibody in Japanese Subjects With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date :
May 20, 2021
Anticipated Primary Completion Date :
Sep 16, 2022
Anticipated Study Completion Date :
Sep 16, 2022

Arms and Interventions

ArmIntervention/Treatment
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.

Drug: Talquetamab
Talquetamab will be administered subcutaneously.
Other Names:
  • JNJ-64407564
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events (AEs) [Up to 1.5 years]

      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.

    2. Number of Participants With Serious Adverse Events (SAEs) [Up to 1.5 years]

      A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    3. Cohorts 1 and 2: Number of Participants With Dose-Limiting Toxicity (DLT) [Up to 28 days]

      Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    4. Cohort 3: Number of Participants With DLT [Up to 38 days]

      Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    Secondary Outcome Measures

    1. Serum Concentrations of JNJ-64407564 [Up to 1.5 years]

      Serum concentrations of JNJ-64407564 will be assessed.

    2. Systemic Cytokine Concentrations [Up to 1.5 years]

      Cytokine concentrations such as concentration of interleukin (IL)-6, Interferon (IFN)-gamma, IL-10 and IL-2 receptors will be measured for biomarker assessment.

    3. Number of Participants With Anti-Talquetamab Antibodies [Up to 1.5 years]

      Number of participants with anti-talquetamab antibodies will be reported for immunogenicity assessment.

    4. Number of Participants With Objective Response [Up to 1.5 years]

      Objective response is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.

    5. Duration of Response (DOR) [Up to 1.5 years]

      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.

    6. Time to Response (TTR) [Up to 1.5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Nagoya City University HospitalNagoyaJapan467-8602
    2National Hospital Organization Okayama Medical CenterOkayamaJapan701-1192
    3Japanese Red Cross Medical CenterShibuyaJapan150-8935
    4Iwate Medical University HospitalShiwa-gunJapan028-3695

    Sponsors and Collaborators

    • Janssen Pharmaceutical K.K.

    Investigators

    • Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Pharmaceutical K.K.
    ClinicalTrials.gov Identifier:
    NCT04773522
    Other Study ID Numbers:
    • CR108930
    • 64407564MMY1003
    First Posted:
    Feb 26, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021