Rituximab in Treating Patients With Peripheral Neuropathy Caused by Monoclonal Gammopathy of Undetermined Significance
Stopped early · Phase 2
Conditions studied: Precancerous Condition
In brief
This study was done to find out if the investigational medication, rituximab, could help relieve the symptoms of peripheral neuropathy (such as numbness \[abnormal protein in the blood\] and weakness of the lower and upper extremities) in people who have monoclonal gammopathy of undetermined significance and people with a symptomatic or smoldering Waldestrom macroglobulinemia. Rituximab is an antibody which attacks a particular type of white blood cell (B Cell). By targeting the B-cells which make the abnormal protein which is involved in causing the nerve trouble, it is hoped that damage to nerve fibers will be stopped and improvement will be allowed to proceed.
Key facts
- Study ID
- NCT00588822
- Run by
- Mayo Clinic
- People needed
- 21
- Starts
- 2005-01-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2014-05-06
Who can join
Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Not pregnant
- Negative serum pregnancy test
- Fertile patients must use an acceptable method of birth control during treatment and for 6 months after completion of treatment
- One of the following birth control measures must be used: birth control pills, intrauterine device, contraceptive injections (Depo-Provera), barrier methods such diaphragm, condom or contraceptive sponge with spermicide
- Adequate bone marrow function as indicated by sufficient precursors of all three cell lines and cellularity of at least 20% on bone marrow biopsy within 6 months
- Platelets > 100,000/mm\^3
- Absolute neutrophil count (ANC) > 1,000/mm\^3
- Hemoglobin > 7 g/dL
- Serum creatinine < 3.0 mg/dL
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 times upper limit of normal
- No history of psychiatric disorder requiring hospitalization, psychiatric consultation, or psychotropic medications within the last year
- Patients with controlled depression are eligible, as defined by the following:
- Stable for at least 6 months
- No increase in psychotropic medications
You may not qualify if…
- History of HIV infection or seropositivity
- History or serological profile suggesting prior hepatitis B virus (HBV) infection (i.e., HbsAg or anti-HBs with anti-HBc)
- Prior HBV vaccination with isolated anti-HBs antibodies is not an exclusion criterion
- HBV infection or non-vaccination-related HBV seropositivity
- Active infection
- New York Heart Association class III or IV heart disease
- History or baseline ECG tracing demonstrating severe recurrent or severe recent (within 3 months) cardiac dysrhythmia (e.g., ventricular tachycardia, torsades de pointes ("Twisting of the Points," a rapid polymorphic Ventricular Tachycardia), or other serious ventricular dysrhythmias) requiring implanted defibrillator treatment
- Confirmed diagnosis of systemic lupus erythematosus (SLE)
- An isolated low titer positive antinuclear antibody test without clinical evidence of SLE is not an exclusion criterion
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Malignancy associated with a paraneoplastic neuropathy
- A history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- A history of known severe primary or secondary immunodeficiency (e.g., common variable immunodeficiency)
- Significant other uncontrolled medical illnesses that may interfere with drug delivery or interpretation of results
- PRIOR CONCURRENT THERAPY:
- No live vaccine therapy within 30 days of enrollment
- No plasmapheresis within 3 months
- No high-dose intravenous immunoglobulin, chemotherapeutic agents, or high-dose corticosteroids (> 10 mg daily or every other day) within 3 months
- No systemic corticosteroids within 3 months (unless needed for adrenal insufficiency or at a stable dose ≤ 10 mg daily)
- No high-dose (> 250 mg/day) vitamin B6 within the past month
- No prior treatment with thalidomide or neurotoxic drugs (e.g., vinca alkaloids, taxol, or platinum)
Where it is running
- Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Mayo Clinic Cancer Center — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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