OncoMatch/Clinical Trials/NCT05248633
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Is NCT05248633 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bortezomib and Lenalidomide for solitary plasmacytoma.
Treatment: Bortezomib · Lenalidomide · Dexamethasone — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L
Kidney function
eGFR < 40mL/min
Liver function
ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN
Cardiac function
Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment
Neutrophil <1×10E9/L，hemoglobin < 8g/dL，or platelet < 75×10E9/L. Severely compromised hepatic or renal function: ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN，or eGFR < 40mL/min. Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.
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