A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria: * Newly diagnosed patients with histologically confirmed MM based on the following criteria: * Clonal plasma cells in the bone marrow * Measurable disease within the past 4 weeks defined by any one of the following: * Serum monoclonal protein ≥ 1.0 g/dL * Urine monoclonal protein \>200 mg/24 hour * Involved serum immunoglobulin free light chain \> 10 mg/dL AND abnormal kappa/lambda ratio * Evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following: * Hypercalcemia: serum calcium \>0.25 mmol/L (\> 1 mg/dL) above upper limit of normal or ≥ 2.75 mmol/L (11 mg/dL) * Anemia: hemoglobin value \<10 g/dL or \> 2 g/dL below lower limit of normal * Bone disease: ≥ 1 lytic lesions on skeletal X-ray, CT, or PET-CT. For patients with 1 lytic lesion, bone marrow should demonstrate ≥10% clonal plasma cells * Clonal bone marrow plasma cell percentage ≥60% * Involved/un-involved serum free light chain ratio ≥100 and involved free light chain \>100 mg/L. * 1 focal lesion on magnetic resonance imaging study (lesion must be \>5 mm) in size * Creatinine Clearance ≥ 60 ml/min. CrCl can be measured or estimated using Cockcroft-Gault method, MDRD, or CKD-EPI formulae * Age ≥ 18 years at the time of signing the informed consent documentation * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil count (ANC) ≥ 1.0 K…