Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling

Phase 2

Conditions

Solitary Plasmacytoma

Treatments

Drug: Dexamethasone

Radiation: radiotherapy

Drug: Lenalidomide

Drug: Bortezomib Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05248633

SP2022

Details and patient eligibility

About

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.

Enrollment

220 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.