A Phase 3 Study Comparing JNJ-79635322 and an anti-BCMAxCD3 Bispecific Antibody in Participants with Relapsed or Refractory Multiple Myeloma

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• 1. 2. Serious underlying medical conditions, such as: a. Evidence of active systemic viral, fungal, or bacterial infection requiring systemic antiviral, antifungal, or antimicrobial therapy and clinically relevant at the time of first dose. b. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. EXCEPTION: Participants with vitiligo, type I diabetes, or prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed or treatment. c. Overt clinical evidence of dementia or altered mental status d. Any of the following within 6 months prior to first dose of study treatment: severe or unstable angina, myocardial infarction, seizure, major thromboembolic events (eg, pulmonary embolism, cerebrovascular accident [including TIA and stroke]), clinically significant ventricular arrhythmias or heart failure New York Heart Association functional classification Class III to IV. Uncomplicated deep vein thrombosis is not considered exclusionary.
• 10. 1 Prior or concurrent exposure to any of the following, in the specified time frame prior to randomization: a. T-cell redirection therapy (eg, CAR-T, bispecific antibody) within 6 months. b. History of receiving both BCMA and GPRC5D-directed therapy c. History of receiving a BCMA-directed bispecific antibody d. An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks before the start of study treatment administration without signs of graft-versus-host disease. e. Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first dose of study drug. f. Treatment with an investigational drug, investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 28 days or ≥5 half-lives, whichever is longer.
• 11. 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. Non-live and non-replication-competent vaccines approved or authorized for emergency use by local health authorities are allowed.
• 12. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• 2. Active hepatitis of infectious origin. a. Seropositive for hepatitis B: defined by a positive test for HBsAg. Participants with resolved infection (ie, participants who are HBsAg negative with positive antibodies to total hepatitis B core antigen [anti-HBc])must be screened using RT-PCR measurement of HBV-DNA levels. Those who are RT-PCR positive will be excluded. Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV-DNA by RT-PCR. (see Section 10.6, Hepatitis B Virus Screening) b. Known hepatitis C infection or positive serologic testing for hepatitis C virus (anti-HCV) antibody. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained at screening or within 3 months prior to first dose of study treatment. c. Other clinically active liver disease of infectious origin.
• 3.Participants who are HIV-positive and meet any of the following: a. Detectable viral load (ie, ≥50 copies/mL) at screening b. CD4+ count ≤300 cells/mm3 at screening c. Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening d. Receive treatment other than continued HAART. A change in HAART due to resistance/progression must occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening. Note: HAART that could interfere with study treatment is excluded (consult the sponsor for a review of medications prior to enrollment).