Study design and patients
multiple myeloma, Guillain–Barré syndrome, squamous cell skin cancer or carcinoma, organomegaly, thromboembolic, malignancy, viral infection, impaired cardiovascular function, psychiatric, amyloidosis, skin changes syndrome, human immunodeficiency virus, prolonged QT syndrome, peripheral sensory or motor neuropathy, including active hepatitis B, peripheral motor polyneuropathy, hypersensitivity, POEMS
CARDIOVASCULAR DISEASE, PLASMA CELL DISORDER, VIRAL INFECTION, AMYLOIDOSIS, EVENTS, REFRACTORY MULTIPLE MYELOMA, ACUTE MYOCARDIAL INFARCTION, INFECTIONS, POLYNEUROPATHY, SMOLDERING MULTIPLE MYELOMA, MULTIPLE MYELOMA, ENDOCRINOPATHY, GRAFT VERSUS HOST DISEASE, MOTOR NEUROPATHY, PLASMA CELL LEUKEMIA, HEPATITIS C, HYPERSENSITIVITY, VIRUS, CARDIAC ARRHYTHMIAS, HUMAN IMMUNODEFICIENCY VIRUS, DISEASE, ACUTE CORONARY SYNDROMES
MagnetisMM-3 is an ongoing, multicenter, open-label, single-arm, phase 2 study to evaluate the efficacy and safety of elranatamab monotherapy in patients with relapsed or refractory multiple myeloma.Eligible patients were male or female (if not pregnant or breastfeeding), 18 years of age or older, willing to follow protocol-specified requirements and complete scheduled visits, with a prior diagnosis of multiple myeloma and measurable disease as defined by IMWG criteriaPatients were excluded if they had smoldering multiple myeloma, active plasma cell leukemia, amyloidosis or polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes syndrome (POEMS), a stem cell transplant ≤12 weeks before enrollment or active graft versus host disease, or any active, uncontrolled bacterial, fungal or viral infection (including active hepatitis B virus, hepatitis C virus, SARS-CoV-2 or human immunodeficiency virus). Active infections had to be resolved at least 14 d before enrollment. Patients were also excluded if they had impaired cardiovascular function or clinically meaningful cardiovascular disease (defined as acute myocardial infarction, acute coronary syndromes, clinically meaningful cardiac arrhythmias, thromboembolic or cerebrovascular events or prolonged QT syndrome) ≤6 months before enrollment, ongoing grade ≥2 peripheral sensory or motor neuropathy, history of Guillain–Barré syndrome or variants or history of any grade ≥3 peripheral motor polyneuropathy, or for cohort B, history of any grade peripheral sensory or motor neuropathy with prior BCMA-directed therapy. Patients with another active malignancy within 3 years before enrollment (except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ), known or suspected hypersensitivity to elranatamab, previous administration of an investigational drug within 30 d or five half-lives preceding the first dose of elranatamab (whichever was longer), previous treatment with an anti-BCMA bispecific antibody or who received a live attenuated vaccine within 4 weeks of the first dose of treatment were also excluded. Patients were also ineligible if they had surgical, medical or psychiatric conditions or laboratory abnormalities that may increase the risk of study participation or (per investigator’s judgment) make the patient inappropriate for the study.Patients were assigned to 1 of 2 independent, parallel cohorts. Efficacy and safety results in patients naïve to BCMA-directed therapies are reported here (Fig. 