Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solitary Plasmacytoma
• Intervention / Treatment: Radiation: radiotherapy; Drug: Bortezomib Injection; Drug: Lenalidomide; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Jian Li; Phone Number: 010-69155020; Email: lijian@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiotherapy	Radiation: radiotherapy; radiotherapy with a dose of 40-50 Gy
Experimental: Chemotherapy combined with radiotherapy	Radiation: radiotherapy; radiotherapy with a dose of 40-50 Gy; Drug: Bortezomib Injection; subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22; Drug: Lenalidomide; Lenalidomide 25mg for 21 days; Drug: Dexamethasone; Dexamethasone 40mg d1,8,15,22

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Anticipated): April 1, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Plasmacytoma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Lenalidomide; Bortezomib
• Other Study ID Numbers: SP2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No