Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

  • End date
    Oct 13, 2026
  • participants needed
  • sponsor
    Peking Union Medical College Hospital
Updated on 13 May 2022


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.

Condition Solitary Plasmacytoma
Treatment Radiotherapy, Dexamethasone, Lenalidomide, bortezomib injection
Clinical Study IdentifierNCT05248633
SponsorPeking Union Medical College Hospital
Last Modified on13 May 2022


Yes No Not Sure

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
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