Actively Recruiting
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
Led by Kosin University Gospel Hospital · Updated on 2023-10-06
54
Participants Needed
1
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial)
CONDITIONS
Official Title
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
- Meeting treatment criteria from the Second International Workshop on Waldenstrom's Macroglobulinemia
- Male or female patients aged 19 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Measurable disease with IgM greater than 0.5 g/dL
- Adequate bone marrow, liver, and kidney function
- Ability to understand and comply with study instructions
- Provided informed consent before starting the study
- Female patients must be post-menopausal for at least 1 year, surgically sterile, or using effective birth control and have a negative pregnancy test; must continue birth control for 6 months after treatment ends
- Male patients must agree to use effective contraception during the study
You will not qualify if you...
- Central nervous system involvement by Waldenstrom's Macroglobulinemia
- Prior treatment with rituximab, lenalidomide, or bortezomib
- Allergies or hypersensitivity to mouse, chimeric, humanized proteins, lenalidomide, or bortezomib
- Low blood counts: absolute neutrophil count under 1,000 / µL or platelet count under 75,000 / µL without transfusion
- Liver enzymes (AST/ALT) more than three times the normal limit
- Renal failure requiring dialysis
- Uncontrolled severe heart disease
- Inability or unwillingness to use antithrombotic therapy
- Peripheral neuropathy greater than Grade 2
- Stroke or brain hemorrhage within 12 months before consent
- Active severe infection
- Known HIV or hepatitis C infection
- Diagnosis of another cancer within 5 years before consent
- Pregnant or breastfeeding
- Need for treatment with strong CYP3A inhibitors
- Acute invasive lung or heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kosin University Gospel Hospital
Busan, Sue-gu, South Korea, 60542
Actively Recruiting
Research Team
H
HoSup Lee, MD, PhD
CONTACT
S
Sujin Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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