Actively Recruiting
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Led by Peking Union Medical College Hospital · Updated on 2024-06-05
220
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Treatment-na�efve solitary plasmacytoma
You will not qualify if you...
- Not appropriate for radiotherapy
- ECOG performance status greater than 2
- Uncontrolled infection
- Other active malignancy
- Pregnancy or lactation
- Prior or current pulmonary embolism
- Unable to tolerate thrombosis prophylaxis, bortezomib, lenalidomide, or dexamethasone
- Seropositive for HIV or hepatitis C, or HBV-DNA over 1000 copies/mL
- Recent myocardial infarction, severe heart failure, uncontrolled angina, or severe arrhythmias within 6 months
- Grade 2 or higher neuropathy
- Low blood counts: neutrophils below 1x10^9/L, hemoglobin below 8 g/dL, or platelets below 75x10^9/L
- Severely impaired liver or kidney function including ALT or AST over 3 times upper limit of normal, total bilirubin over 1.5 times upper limit, or eGFR below 40 mL/min
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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