Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma
Peking Union Medical College Hospital
220 participants
Apr 21, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- treatment-naïve SP.
Exclusion Criteria12
- Not appropriate for radiotherapy.
- ECOG > 2.
- Co-morbidity of uncontrolled infection.
- Co-morbidity of other active malignancy.
- Patients in pregnancy or lactation.
- Prior or concurrent pulmonary embolism.
- Patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone.
- Seropositive for human immunodeficiency virus, seropositive for hepatitis C, or HBV-DNA > 1000 copies/mL.
- Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.
- Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
- 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.
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Interventions
radiotherapy with a dose of 40-50 Gy
subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22
Lenalidomide 25mg for 21 days
Dexamethasone 40mg d1,8,15,22
Locations(1)
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NCT05248633