Trial Outcomes & Findings for Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone (NCT NCT02516423)

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone

Symptomatic myeloma PFS is defined as time from randomization to the first instance of criteria for multiple myeloma (MM). MM is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following: * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); Renal insufficiency: creatinine clearance \<40 mL per min or serum creatinine \>177 μmol/L (\>2 mg/dL); Anaemia: haemoglobin value of \>20 g/L below the lower limit of normal, or a haemoglobin value \<100 g/L; Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT * Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60%; Involved:uninvolved serum free light chain ratio ≥100 ; \>1 focal lesions on MRI studies

MRD was part of a sub-study which required additional consent and funding. Samples were collected from consenting patients and shipped to Alliance Hematologic Malignancy for release to a central laboratory at the end of the study once funding was obtained.