This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab.
The main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).
Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the purpose of, and procedures required for, the study and is willing to participate in the study
Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria
Measurable disease defined as M-protein in the serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL [≥100 mg/L] and abnormal serum immunoglobulin kappa/lambda FLC ratio
Frail according to the Simplified IMWG frailty index
Non-secretory MM or measurable disease by urine or plasmacytoma only
Central nervous system involvement of myeloma
Significant pulmonary dysfunction
Stroke, transient ischemic attack, or seizure within 6 months of eligibility
European Myeloma Network B.V.
Lead sponsor
EMN Trial Office S.r.l. Impresa Sociale
Collaborator
HOVON - Dutch Haemato-Oncology Association
Collaborator
PETHEMA Foundation
Collaborator
Nordic Myeloma Study Group
Collaborator
Janssen Pharmaceutica N.V., Belgium
Collaborator