Brief Title
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
Official Title
A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia
Brief 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)
Detailed Description
Most patients with Waldenstrom's Macroglobulinemia are rare, and most studies are based on
Phase II clinical studies, so the most effective regimen has not been established. However,
in patients without experience of treatment with rituximab monotherapy targeting CD20 antigen
expressed on lymphocytic cells, the response rate is reported to be approximately 25% -45%.
Combined chemotherapy including rituximab is recommended as a primary treatment.
In Korea, there are few studies on Waldenstrom's Macroglobulinemia, and a relatively large
number of patients have studied the data of 71 patients in 2014, retrospectively. In the
present study, we found that the combined chemotherapy regimen with rituximab significantly
improved the overall response rates. Bortezomib may also be effective in the treatment of
Waldenstrom's Macroglobulinemia. Based on this, clinical trials of combined chemotherapy with
rituximab or dexamethasone have been conducted and 80-90% reported However, lenalidomide 15mg
alone was administered, lenalidomide was effective in Waldenstrom's Macroglobulinemia with a
29% overall response rate.
The authors concluded that the combination therapy of rituximab, bortezomib, lenalidomide,
and dexamethasone is an effective treatment regimen that can improve the overall response
rate including complete remission. Patients with Waldenstrom's Macroglobulinemia diagnosed in
Korea we planned this study to evaluate the efficacy and safety of lenalidomide maintenance
therapy with chemotherapy with chemotherapy including rituximab, bortezomib, lenalidomide,
and dexamethasone
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
survival
Condition
Waldenström's Macroglobulinemia
Intervention
Lenalidomide, Bortezomib, Rituximab, Dexamethasone
Study Arms / Comparison Groups
Rituximab&Bortezomib&Lenalidomide&Dexamethasone
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
54
Start Date
March 6, 2019
Completion Date
June 30, 2026
Primary Completion Date
May 31, 2026
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
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03697356
Organization ID
Ballondor
Responsible Party
Principal Investigator
Study Sponsor
Kosin University Gospel Hospital
Study Sponsor
, ,
Verification Date
March 2022