BridgeMD
New treatment option for Solitary Plasmacytoma
Official title SBRT Plus Lenalidomide for Solitary Plasmacytoma: Phase II Trial
ClinicalTrials.gov ID: NCT06863584
What this study is testing
What is Lenalidomide (Revlimid)?
Lenalidomide (Revlimid) is an investigational medicine, being studied as a potential treatment for solitary plasmacytoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- Patients who are not suitable for radiotherapy or unable to receive SBRT due to technical limitations, such as patients with plasmacytoma in the...
- 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...
- Patients with uncontrolled infectious comorbidities.
- Patients with other active malignancies.
- Pregnant or breastfeeding patients.
See the full eligibility 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.