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

Primary Purpose

Waldenström's Macroglobulinemia

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lenalidomide, Bortezomib, Rituximab, Dexamethasone
Sponsored by
Kosin University Gospel Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenström's Macroglobulinemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kosin University Gospel HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab&Bortezomib&Lenalidomide&Dexamethasone

Arm Description

Rituximab&Bortezomib&Lenalidomide&Dexamethasone

Outcomes

Primary Outcome Measures

survival
Response assessment in Waldenström macroglobulinaemia

Secondary Outcome Measures

Full Information

First Posted
October 1, 2018
Last Updated
October 4, 2023
Sponsor
Kosin University Gospel Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03697356
Brief Title
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
Acronym
Ballondor
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kosin University Gospel Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenström's Macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rituximab&Bortezomib&Lenalidomide&Dexamethasone
Arm Type
Experimental
Arm Description
Rituximab&Bortezomib&Lenalidomide&Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Lenalidomide, Bortezomib, Rituximab, Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
survival
Description
Response assessment in Waldenström macroglobulinaemia
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia Male or female patients aged ≥19 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Patients must have measurable disease, IgM > 0.5g/dL Appropriate bone marrow, liver, and kidney function Patients who are able to understand oral and written instructions and who are able to comply with all requirements Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial. 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: Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia Patients who have received rituximab, lenalidomide, or bortezomib Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib 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 Renal failure requiring hemodialysis or peritoneal dialysis Patients with uncontrolled severe heart disease Patients who can not or do not want antithrombotic therapy Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period Patient with a history of stroke or cerebral hemorrhage within 12 months bofore signing ICF Patients who have been diagnosed with a currently unadjusted severe infection Patients with known human immunodeficiency virus (HIV), hepatitis C infection Patients diagnosed with malignancy within 5 years before signing ICF Pregnant or lactating patients Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor Patients with acute diffuse invasive pulmonary disease and cardiovascular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HoSup Lee, MD, PhD
Phone
+82519005820
Email
hs3667@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sujin Lee
Phone
+82519005820
Email
gssj82@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HoSup Lee
Organizational Affiliation
KUGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosin University Gospel Hospital
City
Busan
State/Province
Sue-gu
ZIP/Postal Code
60542
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HoSup Lee, MD, PhD
Phone
82-990-5820
Email
hs52silver@gmail.com,hs3667@hanmail.net
First Name & Middle Initial & Last Name & Degree
Sujun Lee
Phone
82-990-6107
Email
gssj82@naver.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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