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

October 4, 2023 updated by: Ho Sup Lee, Kosin University Gospel Hospital

A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström'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 (Ballondor trial)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab&Bortezomib&Lenalidomide&Dexamethasone
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 2 years
Response assessment in Waldenström macroglobulinaemia
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kosin University Gospel Hospital

Investigators

  • Principal Investigator: HoSup Lee, KUGH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2019

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ballondor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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