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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 platelet \< 75×10E9/L.
* Severely compromised hepatic or renal function: ALT or AST \> 3 × ULN, total bilirubin \> 1.5 × ULN，or eGFR \< 40mL/min.
Primary outcome measure(s)
event-free survival — 2 years EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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