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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04773522
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Janssen Pharmaceutical K.K.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Pharmaceutical K.K., Japan Clinical Trial
Principal Investigator Affiliation	Janssen Pharmaceutical K.K.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Arms & Interventions

Arms

Experimental: Talquetamab

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.

Interventions

Drug: - Talquetamab

Talquetamab will be administered subcutaneously.

Contact a Trial Team

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