A Phase 2 Study of Teclistamab in Combination with Daratumumab or Lenalidomide in Elderly Patients with Newly Diagnosed Multiple Myeloma - IFM2021-01

You may be able to join if

• Patient must be at least ≥ 65 years of age
• A documented diagnosis of multiple myeloma according to IMWG diagnostic criteria: Multiple myeloma is defined as clonal bone marrow plasma cells ≥ 10% or biopsy-proven bone or extramedullary plasmacytoma and one or more of the following myeloma defining events: a.Myeloma milestones: i.Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferation disorder, specifically: oHypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) above the upper limit of normal or >2.75 mmol/L (>11 mg/dL) oRenal impairment: creatinine clearance <40 mL per min or serum creatinine >177 μmol/L (>2 mg/dL) oAnemia: hemoglobin value >20 g/l below the lower limit of normal, or hemoglobin value <100 g/lg oBone lesions: one or more osteolytic lesions on skeletal radiograph, CT or PETCT b.One or more of the following biomarkers of malignancy: i.Percentage of clonal bone marrow plasma cells ≥ 60%. ii.Serum involved:uninvolved free light chain ratioe ≥100 iii.>1 focal lesions on MRI studies and : c.Measurable disease on screening, defined by any of the following: i.Serum monoclonal paraprotein (M protein) level ≥ 0.5 g/dL or urine M protein level ≥ 200 mg/24 hours. ii.Light chain multiple myeloma in which the only measurable disease is by serum free light chain (FLC) levels: serum Ig free light chains ≥ 10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
• Not considered for high-dose chemotherapy with ASCT.
• Have clinical laboratory values meeting the following criteria : -Hemoglobin: ≥ 8 g/dL (≥5 mmol/L; without prior CG transfusion within 7 days prior to laboratory test; use of recombinant human erythropoietin is allowed) ; -Platelets: ≥75×10^9 /L in patients in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×10^9 /L in patients in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before laboratory test) -Absolute neutrophil count: ≥1.0×109 /L (pre-administration of growth factor is allowed, but wait 7 days for G-CSF or GM-CSF and 14 days for pegylated GCSF ). -AST and ALT: ≤2.5×ULN -eGFR: ≥30 mL/min as calculated by the Cockcroft-Gault formula calculation or creatine clearance measured by 24-hour urine collection. -Total bilirubin: ≤2.0×ULN; except in patients with congenital bilirubinemia, such as Gilbert's syndrome (in which case a direct bilirubin ≤1.5×ULN is required). -Serum calcium corrected for albumin: ≤14 mg/dL (≤3.5 mmol/L) or ionized free calcium ≤6.5 mg/dL (≤1.6 mmol/L )
• A male patient must wear a condom during any activity that allows passage of ejaculate to another person during the study and a minimum of 4 weeks after the last dose of Lénalidomide or for at least 90 days after receiving the last dose of other study treatment. If the female partner is of childbearing age, she must also practice a highly effective method of contraception. If the male patient is vasectomized, he must always wear a condom (with or without foam/gel/film/cream/spermicidal suppository), but his female partner is not required to use contraception.