Clinical trial · Interventional
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia
NCT03697356CI-TRIAL-00070253BallondorunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenström's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide, Bortezomib, Rituximab, Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab&Bortezomib&Lenalidomide&Dexamethasone
- description
- Rituximab\&Bortezomib\&Lenalidomide\&Dexamethasone
- interventionNames
- Drug: Lenalidomide, Bortezomib, Rituximab, Dexamethasone
Primary outcomes (1)
- measure
- survival
- timeFrame
- 2 years
- description
- Response assessment in Waldenström macroglobulinaemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.