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

Multiple Myeloma Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04773522
• Other study ID #: CR108930
• Secondary ID: 64407564MMY1003
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 20, 2021
• Est. completion date: August 14, 2024

Study information

• Verified date: June 2024
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 14, 2024
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Talquetamab
Talquetamab will be administered subcutaneously.

Locations

Country	Name	City	State
Japan	Shonan Kamakura General Hospital	Kamakura-shi
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Nagoya City University Hospital	Nagoya
Japan	National Hospital Organization Okayama Medical Center	Okayama
Japan	Japanese Red Cross Medical Center	Shibuya
Japan	Iwate Medical University Hospital	Shiwa-gun

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Serum Concentrations of JNJ-64407564	Serum concentrations of JNJ-64407564 will be assessed.	Up to 1.5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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