SBRT Plus Lenalidomide for Solitary Plasmacytoma: Phase II Trial

A Phase II Trial of Stereotactic Body Radiotherapy (SBRT) With Lenalidomide Maintenance for Solitary Plasmacytoma

Solitary Plasmacytoma (SP) is a rare malignant plasma cell tumor, including Solitary Bone Plasmacytoma (SBP) and Solitary Extramedullary Plasmacytoma (SEP). Radiotherapy is the preferred treatment for SP. Although the local response rate of SP after radiotherapy is as high as 86%, 55% of patients will experience disease progression within 5 years.

Stereotactic Body Radiation Therapy (SBRT), as a new technology for "precision radiotherapy," delivers a higher dose of radiation to the tumor site through a few short treatment sessions while maintaining low-dose exposure to surrounding normal tissues. This approach achieves good local tumor control and effectively reduces radiotherapy-related side effects, making it valuable for application in SP patients. Additionally, numerous preclinical studies have confirmed that SBRT has positive immunomodulatory effects.

Based on data published in the New England Journal of Medicine in 2013, lenalidomide-based immunomodulatory therapy significantly delays the progression of symptomatic myeloma with minimal toxicity in patients with smoldering multiple myeloma.

This study aims to assess the efficacy and safety of combining SBRT with lenalidomide in patients with SP, compared to conventional intensity-modulated radiotherapy. The goal is to extend progression-free survival (PFS) in newly diagnosed SP patients, reduce adverse reactions, and improve quality of life.

Study Overview

• Status: Recruiting
• Conditions: Solitary Plasmacytoma
• Intervention / Treatment: Drug: Lenalidomide (Revlimid); Radiation: SBRT

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ting Zhang, phD.; Phone Number: +86-571-87783521; Email: zezht@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine
      • Contact: Ting Zhang phD; Phone Number: +86-571-87783521; Email: zezht@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with newly diagnosed solitary plasmacytoma (SP).
• Age between 18 and 80 years.
• Diagnosis of SP must meet the following four criteria:

Biopsy-confirmed plasmacytoma in bone or soft tissue. No evidence of clonal plasma cell proliferation in the bone marrow. No other lesions detected on whole-body imaging (whole-body PET-CT or MRI recommended) except for the primary solitary lesion.

No end-organ damage caused by plasma cell disease, including SLiM CRAB [excluding bone destruction caused by the SP itself.

Exclusion Criteria:

• Patients who are not suitable for radiotherapy or unable to receive SBRT due to technical limitations, such as patients with plasmacytoma in the extremities who cannot abduct the affected limb or maintain the treatment position due to pain.
• Eastern Cooperative Oncology Group (ECOG) performance status score greater than 2.
• Patients who meet the diagnostic criteria for multiple myeloma at the time of diagnosis: bone marrow biopsy showing more than 10% plasma cells, serum calcium level above 11.5 mg/dL, serum creatinine above 2 mg/dL, creatinine clearance rate below 40 mL/min, or hemoglobin below 10 g/dL.
• Patients with uncontrolled infectious comorbidities.
• Patients with other active malignancies.
• Pregnant or breastfeeding patients.
• Patients with a history or current pulmonary embolism.
• Patients with a history of autoimmune disease, even if it is controlled.
• Patients who are seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) DNA > 1,000 copies/mL.
• Patients with myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or severe uncontrolled arrhythmia.
• Patients with neuropathy Grade 2 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
• Patients with neutrophil count < 1×10^9/L, hemoglobin < 8 g/dL, or platelet count < 75×10^9/L.
• Patients with severely impaired liver or kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN), total bilirubin > 1.5 × ULN, or estimated glomerular filtration rate (eGFR) < 40 mL/min.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SBRT Plus Lenalidomide; The SBRT will deliver a dose of 30Gy in 5 fractions to the planning target volume (PTV) and/or 35Gy in 5 fractions to the planning gross tumor volume (PGTV). The specific regimen will be determined based on patient's medical condition and tumor characteristics. Lenalidomide will be taken orally at a dose of 10mg, starting from the first day after the completion of radiotherapy, for 21 consecutive days, followed by a 7-day rest period. This cycle will be repeated for a total of four cycles.

Drug: Lenalidomide (Revlimid); 10mg po for 21 days, followed by a 7-day rest period.; Radiation: SBRT; PTV 30Gy/5f and/or PGTV 35Gy/5F.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	PFS measures the percentage of patients who remain free from disease progression over a five-year period.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS was calculated from the enrollment to death	5 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Lenalidomide; sbrt; solitary plasmacytoma
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Plasmacytoma; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: Y2025-0115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No