Ignite Creation Date:
2024-05-05 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00588822
Status:
TERMINATED
Last Update Posted:
2014-05-06
First Post:
2007-12-20
Brief Title:
Rituximab in Treating Patients With Peripheral Neuropathy Caused by Monoclonal Gammopathy of Undetermined Significance
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase II Trial of Rituximab for Peripheral Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance MGUS
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Discontinuation due to the high response rate at the 1st stage and slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This was a Phase II single arm trial evaluating the use of Rituximab administered at standard dose and schedule as an initial cycle of therapy followed by a re-evaluation at 6 months
If progression in neuropathy as indicated by an increase in the Neuropathy Impairment Score NIS of greater than or equal to 10 or a modified Rankin Score increase of 1 grade the patient was off study In addition if the subject elected to pursue other active treatment including but not limited to plasmapheresis high-dose intravenous immuneglobulin IVIG chemotherapeutic agents or high dose corticosteroids or if conditions in the exclusion criteria develop subsequent to enrollment the subject was off study
If the neuropathy is stable or responding NIS of 10 or a modified Rankin Score increase of 1 grade the patient would have received Cycle 2 of rituximab followed by a reevaluation at 12 months
The study had a Simon Optimal two-stage Phase II design α 5 β 10 π0 5 π1 20 The minimum clinically important response rate was 20 The first stage was to include 21 patients and the second stage a total of 41 patients The treatment would be rejected if there were fewer than 2 responders at the first stage or fewer than 5 responders at the second stage The treatment would be accepted for further study if there were at least 5 responders out of 41 patients
If progression in neuropathy as indicated by an increase in the Neuropathy Impairment Score NIS of greater than or equal to 10 or a modified Rankin Score increase of 1 grade the patient was off study In addition if the subject elected to pursue other active treatment including but not limited to plasmapheresis high-dose intravenous immuneglobulin IVIG chemotherapeutic agents or high dose corticosteroids or if conditions in the exclusion criteria develop subsequent to enrollment the subject was off study
If the neuropathy is stable or responding NIS of 10 or a modified Rankin Score increase of 1 grade the patient would have received Cycle 2 of rituximab followed by a reevaluation at 12 months
The study had a Simon Optimal two-stage Phase II design α 5 β 10 π0 5 π1 20 The minimum clinically important response rate was 20 The first stage was to include 21 patients and the second stage a total of 41 patients The treatment would be rejected if there were fewer than 2 responders at the first stage or fewer than 5 responders at the second stage The treatment would be accepted for further study if there were at least 5 responders out of 41 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |