Stanford University
Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.
This is a phase 2 study to evaluate the efficacy of talquetamab with a combination of lenalidomide, and to determine the safety and longitudinal patient reported symptoms and quality of life. Twenty participants with MM who plan to undergo or who have undergone autologous stem cell transplant as a part of their initial therapy and meet the eligibility criteria will be enrolled in the study.
Inclusion Criteria: 1. Participants must have had a confirmed diagnosis of symptomatic multiple myeloma according to according to IMWG diagnostic criteria. 2. Measurable disease at the time of myeloma diagnosis Measurable disease is defined as measurable M protein in the serum (≥ 0.5g/dL) or urine (≥ 200 mg/24h) or serum free light chain assay (defined as dFLC ≥ 10 mg/dL \[≥ 100 mg/L\]; difference between involved and uninvolved free light chain) at the time of diagnosis. Participants with smoldering myeloma are not eligible until they have progressed to symptomatic myeloma. Participants with…
Talquetamab Step up dosing: C1D1: 10 mcg/kg C1D3: 60 mcg/kg C1D5: 400 mcg/kg C1D15: 800 mcg/kg Talquetamab 800 mg/kg SC Q4W in 28-day cycle for Cycles 2-13
Lenalidomide 10 mg, 3 weeks on 1 week off, until PD/ intolerance, C2-13 (Lenalidomide 5 mg for creatinine clearance 30-60 ml/min)
Arctuva estimate
Verify or correct the compensation shown for this listing.