Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: radiotherapy, Bortezomib Injection, Lenalidomide, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Solitary Plasmacytoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma
Overview
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.
Interventions
- Radiation radiotherapy
radiotherapy with a dose of 40-50 Gy - Drug Bortezomib Injection
subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22 - Drug Lenalidomide
Lenalidomide 25mg for 21 days - Drug Dexamethasone
Dexamethasone 40mg d1,8,15,22
Primary outcome measures
- event-free survival [Time frame: 2 years]
Secondary outcome measures (3)
- overall survival [Time frame: 2 years]
- response rate [Time frame: 2 years]
- adverse events [Time frame: collected until 30 days after treatment completion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT05248633 · SP2022