Phase 3 Randomized Study of JNJ‑79635322 Versus Teclistamab in Relapsed or Refractory Multiple Myeloma After 1–3 Prior Lines Including Anti‑CD38 Antibody and Lenalidomide

The primary objective is to assess efficacy of the investigational trispecific antibody JNJ-79635322 versus the comparator teclistamab in participants with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, including an anti‑CD38 antibody and lenalidomide.

The trial enrolled 494 individuals diagnosed with relapsed or refractory multiple myeloma. Eligible participants were adults aged 18 years or older, including both female and male patients. All subjects had measurable disease and had previously received one to three lines of antimyeloma therapy, which required exposure to an anti‑CD38 antibody and lenalidomide. Enrollment required an ECOG performance status of 0 to 2, indicating ambulatory to partially active functional capacity. The study population consisted of patients with disease that had either relapsed after a prior response or was refractory, as defined by International Myeloma Working Group criteria. No specific lifestyle restrictions were reported in the source data.

The study is a Phase 3, randomized, controlled trial evaluating the efficacy of the investigational trispecific antibody JNJ‑79635322 compared with the subcutaneous comparator teclistamab in adults with relapsed or refractory multiple myeloma who have received 1–3 prior lines of therapy, including an anti‑CD38 antibody and lenalidomide. Participants are assigned in a 1:1 ratio to receive either JNJ‑79635322 or teclistamab; allocation is concealed and treatment administration is subcutaneous. The overall protocol spans from the anticipated first enrollment on 10 August 2026 to the final database lock on 29 December 2032, with each participant remaining in the study for the duration of treatment plus follow‑up until disease progression, unacceptable toxicity, withdrawal, or the end‑of‑study visit. Study visits are scheduled as follows:

• Screening visit to confirm eligibility, obtain baseline disease assessments, and record performance status.
• Baseline (day 1) visit for randomization and first dose administration.
• Regular follow‑up visits (e.g., every 4 weeks) to monitor safety, assess response, and collect laboratory data.
• End‑of‑study visit occurring after the last dose or at the time of documented disease progression, during which final efficacy and safety evaluations are performed.

The investigational product, JNJ-79635322, is an IgG1 trispecific monoclonal antibody directed against the T‑cell receptor CD3, B‑cell maturation antigen, and G‑protein‑coupled receptor class C group 5 member D. It is supplied as a solution for injection for subcutaneous use. The protocol specifies a dose of 0 mg per administration; the exact dosing schedule and frequency are defined in the study treatment plan and are monitored for adherence at each study visit. The agent has been designated as an orphan drug.

The comparator product, teclistamab, is a monoclonal antibody formulated as a solution for injection for subcutaneous use. The prescribed dose is 0 mg per administration, with the dosing interval and schedule outlined in the study protocol. Administration is performed by qualified personnel, and compliance is assessed through dosing logs and regular pharmacovigilance assessments.

All subcutaneous injections are delivered under aseptic conditions using pre‑filled syringes. Participants receive the assigned treatment according to the predetermined schedule, and dosing compliance is tracked by study staff via electronic case report forms and pill‑count‑type verification for injectable volumes. Monitoring includes observation for immediate injection‑site reactions and periodic assessment of laboratory parameters to ensure safety and protocol adherence.

Efficacy will be evaluated using two co‑primary endpoints: CR (complete response) or better, and progression‑free survival (PFS). The proportion of participants achieving a CR or better will be determined by disease assessments conducted according to the study protocol, and PFS will be measured from the date of randomization to the first documented disease progression or death from any cause.