MGUS Rituximab Research Study
A research trial of intravenous rituximab (a monoclonal antibody) is being undertaken
for adult patients with paraproteinemic neuropathy.
Once the individual completes baseline screening procedures and meets inclusion and
exclusion criteria (see below), infusions are arranged at Mayo Clinic, either in
Scottsdale, Rochester, or Jacksonville.
The research trial lasts a total of two years for each subject. Clinical appointments for
screening and baseline assessments are available. The Rituximab is provided free of
charge.
For further information contact:
Teri Radam, Mayo Clinic, Scottsdale, AZ (480-301-8756)
Darcy Rauchwarter, Mayo Clinic, Rochester, MN (507-284-9360)
Jenna Rogers, Mayo Clinic, Jacksonville, FL (904-953-6136)
Inclusion Criteria
Exclusion Criteria
Adults age 21-90, able to give informed consent
HIV infection or seropositivity
Monoclonal protein in the serum (< 3 g/dL) or
Positive Hepatitis B virus (HBV) serology
urine, or a monoclonal serum free light chain
(HbsAg, anti-HBs, or anti-HBc).
Neuropathy Impairment Score 25
Pregnancy
Stable or progressive neuropathy (i.e. not
Active infection or receipt of live vaccine
currently improving)
within 30 days of enrollment
Hemoglobin >7 gm/dL
Malignancies within the last five years
Platelet count >100,000/mm3
Psychiatric disorder requiring hospitalization or
psychotropic medications with the last year
ANC >1000/mm3
NY Heart Classification III or IV heart disease
Bone marrow plasma cells < 10%
Multiple myeloma, AL-amyloidosis,
lymphoma, or HBV infection or seropositivity
Creatinine <3.0 mg/dL; AST or ALT <2x upper
Prior exposure to neurotoxic drugs or vitamins
limits of normal
Acceptable method of birth control during
Plasmapheresis, high-dose intravenous
treatment and for six months after completion
immuneglobulin, chemotherapeutic agents, or
of treatment
high dose corticosteroids within 3 months
Adequate bone marrow function and cellularity
Evidence of diabetes mellitus or other causes of
of at least 20% within 6 months on biopsy
neuropathy or severe immunodeficiency
No evidence of amyloidosis or lymphoma
Severe reactions to humanized or murine
monoclonal antibodies
Subject has provided written informed consent
Significant other uncontrolled medical illnesses

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