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

NCT04773522 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10893064407564MMY1003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Serum Concentrations of JNJ-64407564

  Up to 1.5 years

• Systemic Cytokine Concentrations

  Up to 1.5 years

• Number of Participants With Anti-Talquetamab Antibodies

  Up to 1.5 years

• Number of Participants With Objective Response

  Up to 1.5 years

• Duration of Response (DOR)

  Up to 1.5 years

Study Arms (1)

Talquetamab

EXPERIMENTAL

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

Interventions

Talquetamab DRUG

Talquetamab will be administered subcutaneously.

Also known as: JNJ-64407564

Talquetamab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (6)

Shonan Kamakura General Hospital

Kamakura-shi, 247-8533, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277 8577, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

Location

Japanese Red Cross Medical Center

Shibuya City, 150-8935, Japan

Location

Iwate Medical University Hospital

Shiwa-gun, 028-3695, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: February 26, 2021
• Study Start: May 20, 2021
• Primary Completion: October 14, 2022
• Study Completion: September 4, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)