NCT05248633

Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solitary Plasmacytoma

Interventions

Type	Name	Description
RADIATION	radiotherapy	radiotherapy with a dose of 40-50 Gy
DRUG	Bortezomib Injection	subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22
DRUG	Lenalidomide	Lenalidomide 25mg for 21 days
DRUG	Dexamethasone	Dexamethasone 40mg d1,8,15,22

Timeline

• Start date: 2022-04-21
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2022-02-21
• Last updated: 2024-06-05

Locations

1 site across 1 country: China