Solitary Osseous Plasmacytoma Clinical Trial
Official title:
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
This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more effective, and whether adding these treatments after radiation therapy is more effective than radiation therapy alone in treating patients with solitary plasmacytoma of bone.
This phase III randomized clinical trial was designed to assess the impact of the addition of ixazomib, lenalidomide, and dexamethasone to zoledronic acid the multiple myeloma progression rate at 5 years. A dynamic allocation procedure will be used to allocate an equal number of patients to each of the treatment arms. This procedure will balance the number of patients which falls into each of the following categories between the two treatment arms: 1. % of abnormal plasma cells in the bone marrow: 5-9% 2. age < 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal protein/clonal light chains present in the blood or urine 3. age < 60; % of abnormal plasma cells in the bone marrow < 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease 4. age ≥ 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal protein/clonal light chains present in the blood or urine 5. age ≥ 60; % of abnormal plasma cells in the bone marrow < 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease The primary and secondary objectives are described below. 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 1. 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. 2. To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in extending overall survival. 3. To examine the pharmacodynamics effects of treatment on biochemical markers of bone formation (osteocalcin bone-specific alkaline phosphatase), resorption (serum CTX), and metabolism (OPG). Follow-up requirements after documentation of progression to multiple myeloma includes a maximum of five years following registration. ;