R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
NCT ID: NCT03697356
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
54 participants
INTERVENTIONAL
2019-03-06
2026-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab&Bortezomib&Lenalidomide&Dexamethasone
Rituximab\&Bortezomib\&Lenalidomide\&Dexamethasone
Lenalidomide, Bortezomib, Rituximab, Dexamethasone
step 1; R-VRD induction : rituximab, bortezomib, lenalidomide, and dexamethasone induction
* Rituximab 375 mg/m2 intravenous on day 1
* Bortezomib 1.3mg/m2 subcutaneous on day 1, 8, 15
* Lenalidomide 15mg p.o on day 1-21
* Dexamethasone 20 mg/m2 intravenous or p.o on day 1-4
Step 2 ; Maintenance Beginning 8 weeks after completion of induction therapy, patients receive lenalidomide 10mg once day 1-21 for 4 weeks. Treatment repeats every 1 months for 24 months.
Interventions
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Lenalidomide, Bortezomib, Rituximab, Dexamethasone
step 1; R-VRD induction : rituximab, bortezomib, lenalidomide, and dexamethasone induction
* Rituximab 375 mg/m2 intravenous on day 1
* Bortezomib 1.3mg/m2 subcutaneous on day 1, 8, 15
* Lenalidomide 15mg p.o on day 1-21
* Dexamethasone 20 mg/m2 intravenous or p.o on day 1-4
Step 2 ; Maintenance Beginning 8 weeks after completion of induction therapy, patients receive lenalidomide 10mg once day 1-21 for 4 weeks. Treatment repeats every 1 months for 24 months.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Kosin University Gospel Hospital
OTHER
Responsible Party
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Ho Sup Lee
MD, PhD. associate professor.
Principal Investigators
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HoSup Lee
Role: PRINCIPAL_INVESTIGATOR
KUGH
Locations
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Kosin University Gospel Hospital
Busan, Sue-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ballondor
Identifier Type: -
Identifier Source: org_study_id
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