OncoMatch/Clinical Trials/NCT06863584
SBRT Plus Lenalidomide for Solitary Plasmacytoma: Phase II Trial
Is NCT06863584 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lenalidomide (Revlimid) for solitary plasmacytoma.
Treatment: Lenalidomide (Revlimid) — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
neutrophil count ≥ 1×10^9/L, hemoglobin ≥ 8 g/dL, platelet count ≥ 75×10^9/L
Kidney function
eGFR ≥ 40 mL/min, serum creatinine ≤ 2 mg/dL
Liver function
ALT or AST ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN
Cardiac function
No myocardial infarction within 6 months, NYHA Class III or IV heart failure, uncontrolled angina, or severe uncontrolled arrhythmia
ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN, eGFR < 40 mL/min, serum creatinine > 2 mg/dL, neutrophil count < 1×10^9/L, hemoglobin < 8 g/dL, platelet count < 75×10^9/L, myocardial infarction within 6 months, NYHA Class III or IV heart failure, uncontrolled angina, or severe uncontrolled arrhythmia [all excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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