A Phase 2 interventional study of radiotherapy and Bortezomib Injection in Solitary Plasmacytoma, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
2,314 studies on the registry are indexed under Neoplasms, Plasma Cell; 247 are open to participants now.
This study's planned enrollment of 220 is above the median of 39 across 1,828 interventional studies indexed under Neoplasms, Plasma Cell.
Browse Neoplasms, Plasma Cell studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Radiation: radiotherapy
Radiation: radiotherapy · Drug: Bortezomib Injection · Drug: Lenalidomide · Drug: Dexamethasone
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
event-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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Studies of the drugs tested here: Bortezomib · Lenalidomide · Dexamethasone
Peking Union Medical College Hospital →