A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
Multiple Myeloma
Phase III
Adults
Mol. targeted/Immunotherapy/Biologics
JNJ-79635322,
Teclistamab
Baljevic, Muhamed
International
Vanderbilt University
08-27-2026
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: 1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria 2. 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 anti-cluster of differentiation (CD)38 antibody
Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria
Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
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:
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, or during study treatment
Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: 1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria 2. 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 anti-cluster of differentiation (CD)38 antibody
Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria
Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
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:
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, or during study treatment
