NCT06863584

SBRT Plus Lenalidomide for Solitary Plasmacytoma: Phase II Trial

A Phase II Trial of Stereotactic Body Radiotherapy (SBRT) With Lenalidomide Maintenance for Solitary Plasmacytoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Solitary Plasmacytoma (SP) is a rare malignant plasma cell tumor, including Solitary Bone Plasmacytoma (SBP) and Solitary Extramedullary Plasmacytoma (SEP). Radiotherapy is the preferred treatment for SP. Although the local response rate of SP after radiotherapy is as high as 86%, 55% of patients will experience disease progression within 5 years. Stereotactic Body Radiation Therapy (SBRT), as a new technology for "precision radiotherapy," delivers a higher dose of radiation to the tumor site through a few short treatment sessions while maintaining low-dose exposure to surrounding normal tissues. This approach achieves good local tumor control and effectively reduces radiotherapy-related side effects, making it valuable for application in SP patients. Additionally, numerous preclinical studies have confirmed that SBRT has positive immunomodulatory effects. Based on data published in the New England Journal of Medicine in 2013, lenalidomide-based immunomodulatory therapy significantly delays the progression of symptomatic myeloma with minimal toxicity in patients with smoldering multiple myeloma. This study aims to assess the efficacy and safety of combining SBRT with lenalidomide in patients with SP, compared to conventional intensity-modulated radiotherapy. The goal is to extend progression-free survival (PFS) in newly diagnosed SP patients, reduce adverse reactions, and improve quality of life.

Conditions

• Solitary Plasmacytoma

Interventions

Type	Name	Description
DRUG	Lenalidomide (Revlimid)	10mg po for 21 days, followed by a 7-day rest period.
RADIATION	SBRT	PTV 30Gy/5f and/or PGTV 35Gy/5F.

Timeline

• Start date: 2025-02-10
• Primary completion: 2027-03-31
• Completion: 2032-03-01
• First posted: 2025-03-07
• Last updated: 2025-03-07

Locations

1 site across 1 country: China