Details regarding the phase 1 study design and methods have been reported previously.9 (link) In brief, eligible patients were 18 years of age or older and had a documented diagnosis of relapsed or refractory myeloma according to the criteria of the International Myeloma Working Group.10 (link) Patients must have previously received at least three lines of therapy (including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody) and have had progressive, measurable disease at screening. Previous treatment with a BCMA-targeted therapy was not allowed. Eligible patients had a score of 0 or 1 on the Eastern Cooperative Oncology Group performance-status scale (which ranges from 0 to 5, with higher scores indicating greater disability). Full eligibility criteria are provided in the protocol, which is available with the full text of this article at NEJM.org .
Patients received once-weekly subcutaneous teclistamab at a dose of 1.5 mg per kilogram, which had been preceded by step-up doses of 0.06 and 0.3 mg per kilogram.9 (link) The step-up doses were separated by 2 to 4 days and were completed 2 to 4 days before the administration of the first full teclistamab dose. Hospitalization and pre-medication with dexamethasone (16 mg), acetaminophen, and diphenhydramine were required for each step-up dose and for the first full dose of teclistamab. The cycle duration was 21 days in phase 1 and 28 days in phase 2. Patients continued to receive teclistamab until the occurrence of disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study (defined as 2 years after the administration of the first dose of teclistamab in the last enrolled patient).
Patients received once-weekly subcutaneous teclistamab at a dose of 1.5 mg per kilogram, which had been preceded by step-up doses of 0.06 and 0.3 mg per kilogram.9 (link) The step-up doses were separated by 2 to 4 days and were completed 2 to 4 days before the administration of the first full teclistamab dose. Hospitalization and pre-medication with dexamethasone (16 mg), acetaminophen, and diphenhydramine were required for each step-up dose and for the first full dose of teclistamab. The cycle duration was 21 days in phase 1 and 28 days in phase 2. Patients continued to receive teclistamab until the occurrence of disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study (defined as 2 years after the administration of the first dose of teclistamab in the last enrolled patient).
