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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Talquetamab

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kamakura-shi, Japan, 247-8533
    • Shonan Kamakura General Hospital
  • Kashiwa, Japan, 277 8577
    • National Cancer Center Hospital East
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center
  • Shibuya City, Japan, 150-8935
    • Japanese Red Cross Medical Center
  • Shiwa-gun, Japan, 028-3695
    • Iwate Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: JNJ-64407564

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	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.	Up to 1.5 years
Number of Participants With Serious Adverse Events (SAEs)	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.	Up to 1.5 years
Cohorts 1 and 2: Number of Participants With Dose-Limiting Toxicity (DLT)	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.	Up to 28 days
Cohort 3: Number of Participants With DLT	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.	Up to 38 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentrations of JNJ-64407564	Serum concentrations of JNJ-64407564 will be assessed.	Up to 1.5 years
Systemic Cytokine Concentrations	Cytokine concentrations such as concentration of interleukin (IL)-6, Interferon (IFN)-gamma, IL-10 and IL-2 receptors will be measured for biomarker assessment.	Up to 1.5 years
Number of Participants With Anti-Talquetamab Antibodies	Number of participants with anti-talquetamab antibodies will be reported for immunogenicity assessment.	Up to 1.5 years
Number of Participants With Objective Response	Objective response is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.	Up to 1.5 years
Duration of Response (DOR)	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.	Up to 1.5 years
Time to Response (TTR)	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.	Up to 1.5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): October 14, 2022
• Study Completion (Actual): September 4, 2025

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; talquetamab
• Other Study ID Numbers: CR108930; 64407564MMY1003 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• 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