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

NCT03697356 | Recruiting Phase 2

• 1 other identifier: Ballondor
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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)

Conditions

Waldenström's Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• survival

  Response assessment in Waldenström macroglobulinaemia

  2 years

Study Arms (1)

Rituximab&Bortezomib&Lenalidomide&Dexamethasone

EXPERIMENTAL

Rituximab\&Bortezomib\&Lenalidomide\&Dexamethasone

Drug: Lenalidomide, Bortezomib, Rituximab, Dexamethasone

Interventions

Lenalidomide, Bortezomib, Rituximab, Dexamethasone DRUG

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.

Rituximab&Bortezomib&Lenalidomide&Dexamethasone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kosin University Gospel Hospital: lead

Study Sites (1)

Kosin University Gospel Hospital

Busan, Sue-gu, 60542, South Korea

RECRUITING

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Lenalidomide; Bortezomib; Rituximab; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• HoSup Lee

  KUGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HoSup Lee, MD, PhD

CONTACT

+82519005820; hs3667@hanmail.net

Sujin Lee

CONTACT

+82519005820; gssj82@naver.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. associate professor.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 5, 2018
• Study Start: March 6, 2019
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)