Clinical trial NCT04773522: A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1 Study of JNJ-64407564, a Humanized GPRC5D * CD3 Bispecific Antibody in Japanese Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 1.5 years
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 1.5 years
measure: Cohorts 1 and 2: Number of Participants With Dose-Limiting Toxicity (DLT)
timeFrame: Up to 28 days
measure: Cohort 3: Number of Participants With DLT
timeFrame: Up to 38 days
Secondary outcomes:
measure: Serum Concentrations of JNJ-64407564
timeFrame: Up to 1.5 years
measure: Systemic Cytokine Concentrations
timeFrame: Up to 1.5 years
measure: Number of Participants With Anti-Talquetamab Antibodies
timeFrame: Up to 1.5 years
measure: Number of Participants With Objective Response
timeFrame: Up to 1.5 years
measure: Duration of Response (DOR)
timeFrame: Up to 1.5 years
measure: Time to Response (TTR)
timeFrame: Up to 1.5 years
Other outcomes:
Locations:
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Shibuya
country: Japan
facility: Japanese Red Cross Medical Center
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: