Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CR108930
- SECONDARY ID:
64407564MMY1003
- NCT ID:
NCT04773522
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Talquetamab | JNJ-64407564 | Talquetamab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Talquetamab | Experimental | Participants will receive talquetamab injection subcutaneously (SC) in 2 cohorts: Cohort 1 and Cohort 2 as 2 step-up doses followed by a treatment dose. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants With Adverse Events (AEs) |
Time Frame: | Up to 1.5 years |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Serum Concentrations of JNJ-64407564 |
Time Frame: | Up to 1.5 years |
Safety Issue: | |
Description: | Serum concentrations of JNJ-64407564 will be assessed. |
Measure: | Systemic Cytokine Concentrations |
Time Frame: | Up to 1.5 years |
Safety Issue: | |
Description: | Cytokine concentrations such as concentration of interleukin (IL)-6, Interferon (IFN)-gamma, IL-10 and IL-2 receptors will be measured for biomarker assessment. |
Measure: | Number of Participants With Anti-Talquetamab Antibodies |
Time Frame: | Up to 1.5 years |
Safety Issue: | |
Description: | Number of participants with anti-talquetamab antibodies will be reported for immunogenicity assessment. |
Measure: | Number of Participants With Objective Response |
Time Frame: | Up to 1.5 years |
Safety Issue: | |
Description: | Objective response is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria. |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 1.5 years |
Safety Issue: | |
Description: | 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. |
Measure: | Time to Response (TTR) |
Time Frame: | Up to 1.5 years |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Janssen Pharmaceutical K.K. |
Last Updated
June 18, 2021