Clinical trial · Interventional
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solitary Plasmacytoma | Solitary Plasmacytoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib Injection | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy
- interventionNames
- Radiation: radiotherapy
- type
- EXPERIMENTAL
- label
- Chemotherapy combined with radiotherapy
- interventionNames
- Radiation: radiotherapy
- Drug: Bortezomib Injection
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- event-free survival
- timeFrame
- 2 years
- description
- EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available