Abstract
BackgroundMaintenance treatment after autologous bone marrow transplantation in multiple myeloma improves the outcome of patients. We designed a phase II clinical trial to evaluate the treatment with IL2 and zoledronate after autologous bone marrow transplantation in myeloma patients.MethodsPatients with a histologically proven diagnosis of multiple myeloma become eligible if achieved a very good partial remission in bone marrow samples after 3 months from autologous bone marrow transplantation. IL2 was administered from day 1 to 7. In the first cycle, the daily dose was 2 × 106 IU, whereas, in subsequent ones the IL2 dose was progressively escalated, with +25% increases at each cycle, until evidence of toxicity or up to 8 × 106 IU. Four mg of zoledronic acid were infused on day 2. Flow cytometry analysis of γδ-lymphocytes was performed at days 1 and 8 of treatment cycles.ResultsForty-four patients have been enrolled between 2013 and 2016. The median time to progression was 22.5 months (95% CI 9.7–35.2). A complete remission with a negative immunofixation was obtained in 18% of patients and correlated with a significantly longer time to progression (p = 0.015). Treatment was well tolerated without G3 or 4 toxicities. After a week of treatment with IL2 and zoledronate, γδ lymphocytes, Vγ9δ2, CD57+, effector, late effector, and memory γδ increased but in subsequent cycles, there was a progressive reduction of this expansion.ConclusionsThe maintenance treatment with IL2 and Zoledronate has a modest activity in myeloma patients after autologous bone marrow transplantation.EudraCT Number2013-001188-22.
Highlights
Multiple myeloma is still a deadly disease despite relevant progress in therapy
Maintenance treatment after autologous bone marrow transplantation in multiple myeloma improves the outcome of patients
The maintenance treatment with IL2 and Zoledronate has a modest activity in myeloma patients after autologous bone marrow transplantation
Summary
Multiple myeloma is still a deadly disease despite relevant progress in therapy. The combination of chemotherapy with proteasome inhibitors, immunomodulatory drugs, and newly therapeutic antibodies have improved patients’ prognosis. Maintenance has been evaluated to extend duration of response in treated patients and clinical trials have begun with interferon schedule [1] followed by the more promising thalidomide [2,3,4] and recently lenalidomide [5,6,7]. Our group has demonstrated the anti-myeloma activity of oligoclonal gd T-cells after reduced intensity allogeneic transplantation in multiple myeloma. These results suggest a possible role of gd lymphocytes in the eradication of the disease [8]. Maintenance treatment after autologous bone marrow transplantation in multiple myeloma improves the outcome of patients. We designed a phase II clinical trial to evaluate the treatment with IL2 and zoledronate after autologous bone marrow transplantation in myeloma patients
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