Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytom
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
| Condition(s) | Solitary Plasmacytoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * treatment-naïve SP. Exclusion Criteria: * 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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Peking Union Medical College Hospital |
| Locations | Beijing, China |
| Start date | 2022-04-21 |
| NCT ID | NCT05248633 |
| Official listing | https://clinicaltrials.gov/study/NCT05248633 |