Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Study Overview
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Brief Summary
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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.

Official Title
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Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma

Conditions
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Solitary Plasmacytoma

Intervention / Treatment
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* Radiation: radiotherapy
* Drug: Bortezomib Injection
* Drug: Lenalidomide
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy<br> | Radiation: radiotherapy<br>* radiotherapy with a dose of 40-50 Gy<br>|
| Experimental: Chemotherapy combined with radiotherapy<br> | Radiation: radiotherapy<br>* radiotherapy with a dose of 40-50 Gy<br>Drug: Bortezomib Injection<br>* subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22<br>Drug: Lenalidomide<br>* Lenalidomide 25mg for 21 days<br>Drug: Dexamethasone<br>* Dexamethasone 40mg d1,8,15,22<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event-free survival | EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | OS was calculated from randomization to death | 2 years | 
| response rate | assessed according to M protein level, RECIST 1.1 and PET-CT | 2 years | 
| adverse events | graded according to CTCAE | collected until 30 days after treatment completion |