Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05248633

Enrollment

220

Registered

2022-02-21

Start date

2022-04-21

Completion date

2026-10-31

Last updated

2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solitary Plasmacytoma

Brief summary

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

RADIATIONradiotherapy

radiotherapy with a dose of 40-50 Gy

DRUGBortezomib Injection

subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22

DRUGLenalidomide

Lenalidomide 25mg for 21 days

DRUGDexamethasone

Dexamethasone 40mg d1,8,15,22

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026