The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
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 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to 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
Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Parallel
JNJ-79635322
DrugJNJ-79635322 will be administered as SC injection.
Teclistamab
DrugTeclistamab will be administered as SC injection.
Complete Response (CR) or Better
CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.
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.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
Very Good Partial Response (VGPR) or Better
VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.
Duration of Response (DoR)
DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first.
Minimal Residual Disease (MRD)-negative CR
MRD-negative CR is defined as the percentage of participants with CR or better who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy.
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