Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solitary Plasmacytoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy

Group Type ACTIVE_COMPARATOR

radiotherapy

Intervention Type RADIATION

radiotherapy with a dose of 40-50 Gy

Chemotherapy combined with radiotherapy

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

radiotherapy with a dose of 40-50 Gy

Bortezomib Injection

Intervention Type DRUG

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

Lenalidomide

Intervention Type DRUG

Lenalidomide 25mg for 21 days

Dexamethasone

Intervention Type DRUG

Dexamethasone 40mg d1,8,15,22

Interventions

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radiotherapy

radiotherapy with a dose of 40-50 Gy

Intervention Type RADIATION

Bortezomib Injection

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

Intervention Type DRUG

Lenalidomide

Lenalidomide 25mg for 21 days

Intervention Type DRUG

Dexamethasone

Dexamethasone 40mg d1,8,15,22

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No