Rituximab in Treating Patients With Peripheral Neuropathy Caused by Monoclonal Gammopathy of Undetermined Significance

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT00588822
Phase
PHASE2
Status
Terminated

Conditions

  • Precancerous Condition

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    Rituximab will be given as a 375 mg/m\^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22).

Study Details

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 Dates

Start date
Jan 31, 2005
Status verified
Apr 2014
Primary completion
Jan 31, 2009
Completion
Feb 28, 2011

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months. Rituximab will be given as a 375 mg/m\^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22).

Primary Outcome Measure

Percentage of Subjects With at Least 10 Points Improvement in the Neuropathy Impairment Score (NIS) for Either Side of the Body at 6 Months [ Time Frame: baseline, 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic ScottsdaleScottsdaleArizona85259-5499-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

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By research site
Mayo Clinic Scottsdale· Scottsdale, AZMayo Clinic - Jacksonville· Jacksonville, FLMayo Clinic Cancer Center· Rochester, MN

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