Actively Recruiting
SBRT Plus Lenalidomide for Solitary Plasmacytoma: Phase II Trial
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-03-07
41
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SBRT Plus Lenalidomide for Solitary Plasmacytoma: Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed solitary plasmacytoma (SP) patients
- Age between 18 and 80 years
- Biopsy-confirmed plasmacytoma in bone or soft tissue
- No clonal plasma cell proliferation in bone marrow
- No other lesions detected on whole-body imaging except the primary lesion
- No end-organ damage caused by plasma cell disease excluding bone destruction from SP itself
You will not qualify if you...
- Unable to receive SBRT due to technical limitations or pain preventing treatment positioning
- Eastern Cooperative Oncology Group (ECOG) performance status score greater than 2
- Diagnosed multiple myeloma with bone marrow plasma cells >10%, or abnormal calcium, creatinine, clearance, or hemoglobin levels
- Uncontrolled infectious diseases
- Other active malignancies
- Pregnant or breastfeeding
- History or current pulmonary embolism
- History of autoimmune disease
- Positive for HIV, hepatitis C, or hepatitis B with high viral load
- Recent myocardial infarction or severe heart conditions
- Neuropathy Grade 2 or higher
- Low neutrophil, hemoglobin, or platelet counts
- Severely impaired liver or kidney function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
T
Ting Zhang, phD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here