Multiple Myeloma
Conditions
Interventions
Experimental: JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.
Drug: JNJ-79635322
JNJ-79635322 will be administered
Sponsors
Takizawa Manami
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria b. Measurable disease at screening as assessed by central laboratory - Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anticluster of differentiation (CD)38 antibody - Documented evidence of progressive disease (PD) or failure to achieve a response (that is partial response [PR] or better) to the last line of therapy based on investigator's determination of response by IMWG criteria - Have discontinued concurrent use of any other anticancer treatment(including nonpalliative radiotherapy) or investigational agent - Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration
Exclusion criteria
Exclusion criteria: - Active hepatitis of infectious origin - Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM - Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab - Major surgery , (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study - Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, during, or within 90 days after the last dose of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall Response Rate (ORR) ORR is defined as the percentage of participants who achieve partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria. [Time Frame: Up to 5 years and 4 months] 2. Progression-Free Survival (PFS) PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria. [Time Frame: Up to 5 years and 4 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| Refer to Appendix | — |
Countries
Australia, Japan
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed