drugset / Trial / NCT05248633

Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

NCT05248633 ↗

Phase 2 Recruiting 220 enrolled Peking Union Medical College Hospital
RandomizedSingle-groupOpen-labelTreatment

Summary

Solitary plasmacytoma (SP) is characterized by a localized mass of clonal plasma cells with no or minimal bone marrow plasmacytosis. It can present either as EMP or SBP. Radiotherapy is the first-line treatment with high response rate. However, 65-84% SBP patients and 25-35% EMP patients progress at 10 years. We aimed to investigate whether adjuvant bortezomib based chemotherapy with radiotherapy could prolong event-free survival in treatment-naive SP patients compared to that with radiotherapy alone.

Timeline

Start
2022-04-21
Primary completion
2026-04
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Subject Dexamethasone Small molecule 40 mg —
Subject Lenalidomide Other / unclassified 25 mg —

Indications