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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04773522
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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 disease Intervention/treatment Phase
Multiple Myeloma Drug: Talquetamab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 16, 2022
Estimated Study Completion Date : January 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/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 Name: JNJ-64407564




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 1.5 years ]
    Serum concentrations of JNJ-64407564 will be assessed.

  2. Systemic Cytokine Concentrations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773522


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Japan
Shonan Kamakura General Hospital Recruiting
Kamakura-shi, Japan, 247-8533
National Cancer Center Hospital East Recruiting
Kashiwa, Japan, 277-8577
Nagoya City University Hospital Recruiting
Nagoya, Japan, 467-8602
National Hospital Organization Okayama Medical Center Recruiting
Okayama, Japan, 701-1192
Japanese Red Cross Medical Center Recruiting
Shibuya, Japan, 150-8935
Iwate Medical University Hospital Recruiting
Shiwa-gun, Japan, 028-3695
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT04773522    
Other Study ID Numbers: CR108930
64407564MMY1003 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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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:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases