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RECRUITING
NCT05248633
PHASE2

Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2022-04-21

Completion Date

2026-10

Last Updated

2024-06-05

Healthy Volunteers

No

Interventions

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

Locations (1)

Peking Union Medical College Hospital

Beijing, China