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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
radiotherapy with a dose of 40-50 Gy
subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22
Lenalidomide 25mg for 21 days
Dexamethasone 40mg d1,8,15,22
Peking Union Medical College Hospital
Beijing, China
RECRUITINGevent-free survival
EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.
Time frame: 2 years
overall survival
OS was calculated from randomization to death
Time frame: 2 years
response rate
assessed according to M protein level, RECIST 1.1 and PET-CT
Time frame: 2 years
adverse events
graded according to CTCAE
Time frame: collected until 30 days after treatment completion
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