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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients with newly diagnosed solitary plasmacytoma (SP).

• Age between 18 and 80 years.

• Diagnosis of SP must meet the following four criteria:

⁃ Biopsy-confirmed plasmacytoma in bone or soft tissue. No evidence of clonal plasma cell proliferation in the bone marrow. No other lesions detected on whole-body imaging (whole-body PET-CT or MRI recommended) except for the primary solitary lesion.

⁃ No end-organ damage caused by plasma cell disease, including SLiM CRAB \[excluding bone destruction caused by the SP itself.

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Ting Zhang, phD.
zezht@zju.edu.cn
+86-571-87783521
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2032-03-01
Participants
Target number of participants: 41
Treatments
Experimental: SBRT Plus Lenalidomide
The SBRT will deliver a dose of 30Gy in 5 fractions to the planning target volume (PTV) and/or 35Gy in 5 fractions to the planning gross tumor volume (PGTV). The specific regimen will be determined based on patient's medical condition and tumor characteristics. Lenalidomide will be taken orally at a dose of 10mg, starting from the first day after the completion of radiotherapy, for 21 consecutive days, followed by a 7-day rest period. This cycle will be repeated for a total of four cycles.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov