Spots Global Cancer Trial Database for Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

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Trial Identification

Brief Title: Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

Official Title: Phase III Randomised Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

Study ID: NCT02544308

Conditions

Plasmacytoma

Interventions

Lenalidomide

Dexamethasone

No further treatment

Study Description

Brief Summary: The purpose of the trial is to establish whether adjuvant therapy with lenalidomide + dexamethasone after radiotherapy can improve progression free survival in patients with high risk solitary bone plasmacytoma compared with RT only.

Detailed Description: Solitary bone plasmacytoma (SBP) is a localised proliferation of malignant plasma cells (PCs) in the skeleton. The annual UK incidence is 0.4/100,000 (lower than multiple myeloma (MM)) with a peak age incidence at 68 years and there are estimated to be about 260 new cases per year in the United Kingdom (UK). The majority of patients with SBP ultimately progress to myeloma and this is likely due to occult disease not detected by conventional staging methods. Standard care for these patients is involved field radiotherapy (IFRT), but despite radical doses, two-thirds develop multiple myeloma at a median of 2 years, more so if there are high risk features. The IDRIS Trial is a phase III study where the investigators hope to demonstrate that adjuvant lenalidomide + dexamethasone following IFRT prevents the development of multiple myeloma in patients with high risk solitary bone plasmacytoma. Whilst a proportion of solitary bone plasmacytoma is cured with IFRT, it is clear that the majority will progress to multiple myeloma. The investigators are seeking to prevent this outcome by using adjuvant therapy in this study.