Status:
RECRUITING
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Solitary Plasmacytoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- treatment-naïve SP.
Exclusion
- 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.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05248633
Start Date
April 21 2022
End Date
October 1 2026
Last Update
June 5 2024
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China