Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Phase 2

Recruiting

• Conditions: Solitary Plasmacytoma
• Interventions: Radiation: radiotherapy; Drug: Bortezomib Injection; Drug: Lenalidomide; Drug: Dexamethasone

• Registration Number: NCT05248633
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-02-21
• Study Start: 2022-04-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2026-04
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy	radiotherapy	-
Chemotherapy combined with radiotherapy	radiotherapy	-
Chemotherapy combined with radiotherapy	Bortezomib Injection	-
Chemotherapy combined with radiotherapy	Dexamethasone	-
Chemotherapy combined with radiotherapy	Lenalidomide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China