NCT02544308

Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plasmacytoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Experimental Arm
DRUG	Dexamethasone	Experimental Arm
OTHER	No further treatment	Comparator Arm

Timeline

• Start date: 2017-03-10
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2015-09-09
• Last updated: 2022-12-23

Locations

13 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study