Combining chemotherapy with radiotherapy for solitary plasmacytoma treatment
Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma
PHASE2 · Peking Union Medical College Hospital · NCT05248633
This study is testing if combining a specific chemotherapy with radiation can help people with solitary plasmacytoma live longer without their condition getting worse compared to just using radiation alone.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05248633 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining bortezomib-based chemotherapy with radiotherapy in patients with solitary plasmacytoma, a condition characterized by a localized mass of plasma cells. The study aims to determine if this combination can prolong event-free survival compared to radiotherapy alone in treatment-naïve patients. Participants will receive treatments including radiotherapy, bortezomib injection, lenalidomide, and dexamethasone. The trial is designed to provide insights into improving outcomes for patients who typically face a high risk of progression.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve patients diagnosed with solitary plasmacytoma who are eligible for radiotherapy.
Not a fit: Patients with uncontrolled infections, other active malignancies, or those unable to tolerate the study medications will not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could significantly improve event-free survival rates for patients with solitary plasmacytoma.
How similar studies have performed: While the combination of chemotherapy and radiotherapy has been explored in other contexts, this specific approach for solitary plasmacytoma is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solitary Plasmacytoma