Study on Bortezomib and Rituximab for Treating Waldenstrom's Macroglobulinemia
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT00492050
This clinical trial is exploring whether a combination of the drugs bortezomib and rituximab can help control Waldenstrom's Macroglobulinemia (WM). The study also looks at the safety of this treatment and the possibility of collecting stem cells for future use if the disease worsens.
Patient Parameters
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Program Overview
The main goal of this study is to see if the combination of bortezomib and rituximab can effectively manage Waldenstrom's Macroglobulinemia (WM). This treatment may also allow for the collection of stem cells, which could be used in the future if the disease progresses. Researchers will also evaluate the safety and tolerability of this drug combination, followed by other treatments.
Description
Bortezomib works by blocking a protein that helps cancer cells grow, potentially causing them to die. Rituximab attaches to cancer cells, which may also lead to their death. Other drugs like cyclophosphamide, vincristine, doxorubicin, and cladribine are used to stop cancer cells from multiplying, while dexamethasone helps reduce inflammation and treat certain cancers.
Before starting the study, you'll undergo screening tests to ensure you're eligible. These include a physical exam, blood and urine tests, heart activity tests, and scans to check the status of your WM. Women who can have children will need a negative pregnancy test.
If eligible, you'll receive two cycles of bortezomib and rituximab over 35 days. Bortezomib is given through a vein on specific days, and rituximab is also given through a vein on other days. During this time, you'll take an antiviral medication daily.
If you respond well to the initial treatment, stem cells will be collected for potential future use. You'll then receive additional treatment with other drugs. If the initial treatment isn't effective, you'll be given a different combination of drugs.
Throughout the study, you'll have regular tests and exams to monitor your health and the treatment's effects. If the treatment isn't working or causes severe side effects, you may be taken off the study.
After completing the treatment, you'll have follow-up visits to monitor your health and the status of your WM. These visits will include physical exams, blood tests, and possibly scans, depending on your initial results.
This study involves investigational use of some drugs, and up to 38 patients will participate, all at MD Anderson.
Eligibility Criteria
Inclusion Criteria
- Have symptomatic Waldenstrom's Macroglobulinemia (WM) with no prior treatment or limited to steroids/alpha-interferon.
- Acceptable liver and kidney function.
- Women must be post-menopausal, surgically sterilized, or using birth control.
- Men must agree to use contraception.
- Willing to sign informed consent.
- Heart rate of at least 50 bpm.
Exclusion Criteria
- Low platelet or neutrophil counts unless due to WM.
- Poor kidney function unless related to WM.
- Significant nerve problems.
- Recent heart attack or severe heart issues.
- Allergies to study drugs.
- Pregnant or breastfeeding women.
- Recent use of other investigational drugs.
- Serious medical or psychiatric conditions.
- Poor overall health status.
- Active second cancer.
- High lifetime dose of certain chemotherapy drugs.
- Active hepatitis B infection.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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