Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Tecl… (NCT07107529) | Clinical Trial Compass
RecruitingPhase 2
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Italy150 participantsStarted 2025-12-12
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Have clinical laboratory values meeting defined range
✓. Patients of childbearing potential must agree to use adequate/highly effective contraception from the time of signing the informed consent form through 3 months after the last dose of study drug
Exclusion criteria
✕. 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
✕. Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy
✕. Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity.