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
Parallel
Teclistamab
DrugTeclistamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
Talquetamab
DrugTalquetamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
Daratumumab
DrugDartumumab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
Progression Free Survival (PFS) per IMWG criteria
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.
Overall Survival (OS)
Measured from the date of from randomization to the date the subject's death.
Minimal Residual Disease (MRD) negativity rate
Minimal Residual Disease (MRD) negative as determined by NGF at 10\^-5 sensitivity level per International Myeloma Working Group (IMWG) criteria.
Minimal Residual Disease (MRD) negative CR
Minimal Residual Disease (MRD) negative Complete Remission (CR) at the end of fixed treatment duration status as determined by NGF at 10\^-5 sensitivity level and who also achieve CR or better per International Myeloma Working Group (IMWG) criteria.
Sustained Minimal Residual Disease (MRD) negative CR
Sustained MRD-negative CR is defined as patients with CR or better who sustain MRD-negative status, as determined NGF at 10\^-5.
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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
