R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia

Launched by KOSIN UNIVERSITY GOSPEL HOSPITAL · Oct 4, 2018

Keywords

ClinConnect Summary

This clinical trial, called the Ballondor trial, is studying a treatment approach for patients with Waldenström's Macroglobulinemia, a type of blood cancer. The treatment combines rituximab, lenalidomide, and dexamethasone, followed by a maintenance phase with lenalidomide. The goal is to see how effective this treatment is for newly diagnosed patients and to improve their health outcomes.

To participate in the trial, patients need to be at least 19 years old and have a confirmed diagnosis of Waldenström's Macroglobulinemia with measurable disease. They also need to have good organ function and be able to follow instructions. However, certain patients are not eligible, such as those with severe heart disease or who have recently had another type of cancer. Participants can expect regular check-ups and treatment, and they will be closely monitored throughout the study. If you or someone you know is interested, it's important to discuss with a healthcare provider to see if this trial might be a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
• • 2. Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia
• • 3. Male or female patients aged ≥19 years
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • 5. Patients must have measurable disease, IgM \> 0.5g/dL
• • 6. Appropriate bone marrow, liver, and kidney function
• • 7. Patients who are able to understand oral and written instructions and who are able to comply with all requirements
• • 8. Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial.
• • 9. Female patients had to be post-menopausal for ≥1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for ≥6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study.
• Exclusion Criteria:
• • 1. Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia
• • 2. Patients who have received rituximab, lenalidomide, or bortezomib
• • 3. Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib
• 4. One of the following labs or more:
• • Absolute neutrophil count (ANC) \<1,000 / μL
• • Platelet count \<75,000 cells / μL when not transfused
• • Serum AST / ALT\> 3 times the upper limit of normal
• • 5. Renal failure requiring hemodialysis or peritoneal dialysis
• • 6. Patients with uncontrolled severe heart disease
• • 7. Patients who can not or do not want antithrombotic therapy
• • 8. Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period
• • 9. Patient with a history of stroke or cerebral hemorrhage within 12 months bofore signing ICF
• • 10. Patients who have been diagnosed with a currently unadjusted severe infection
• • 11. Patients with known human immunodeficiency virus (HIV), hepatitis C infection
• • 12. Patients diagnosed with malignancy within 5 years before signing ICF
• • 13. Pregnant or lactating patients
• • 14. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
• • 15. Patients with acute diffuse invasive pulmonary disease and cardiovascular disease