Overview
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
Status:
Recruiting
Recruiting
Trial end date:
2023-10-31
2023-10-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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)Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kosin University Gospel HospitalTreatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone acetate
Lenalidomide
Rituximab
Thalidomide
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