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Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment With Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy

Primary objective To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in increasing the time before progression to multiple myeloma. Secondary objectives To assess changes in minimal residual disease [MRD] by flow cytometry from study entry, at the completion of treatment, and at 1 year post registration. To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in extending overall survival. To examine the pharmacodynamics effects of treatment on biochemical markers of bone formation (osteocalcin bone-specific alkaline phosphatase), resorption (serum CTX), and metabolism (OPG). Exploratory objective For those patients who consent to undergo a DXA scan 12 months post randomization, to explore the incidence of shifts in bone mineral density classification after 12 months of treatment. Correlative science objectives To analyze the pathways related to bone metabolism from specimens obtained prior to or following radiation and progression to multiple myeloma. To analyze MRD by sequencing based platform [Sequenta®] in peripheral blood prior to the start of adjuvant treatment and completion of adjuvant treatment and compare results to MRD detection by flow cytometry in bone marrow aspirate.

Primary objective To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in increasing the time before progression to multiple myeloma. Secondary objectives To assess changes in minimal residual disease [MRD] by flow cytometry from study entry, at the completion of treatment, and at 1 year post registration. To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in extending overall survival. To examine the pharmacodynamics effects of treatment on biochemical markers of bone formation (osteocalcin bone-specific alkaline phosphatase), resorption (serum CTX), and metabolism (OPG). Exploratory objective For those patients who consent to undergo a DXA scan 12 months post randomization, to explore the incidence of shifts in bone mineral density classification after 12 months of treatment. Correlative science objectives To analyze the pathways related to bone metabolism from specimens obtained prior to or following radiation and progression to multiple myeloma. To analyze MRD by sequencing based platform [Sequenta®] in peripheral blood prior to the start of adjuvant treatment and completion of adjuvant treatment and compare results to MRD detection by flow cytometry in bone marrow aspirate.