Status:
COMPLETED
A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 NCT...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04773522
Start Date
May 20 2021
End Date
September 4 2025
Last Update
October 1 2025
Active Locations (6)
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1
Shonan Kamakura General Hospital
Kamakura-shi, Japan, 247-8533
2
National Cancer Center Hospital East
Kashiwa, Japan, 277 8577
3
Nagoya City University Hospital
Nagoya, Japan, 467 8602
4
National Hospital Organization Okayama Medical Center
Okayama, Japan, 701-1192