Lenalidomide in Anti-MAG Neuropathy: Phase 1b Study
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|ClinicalTrials.gov Identifier: NCT03701711|
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Demyelinating Sensorimotor Neuropathy||Drug: Lenalidomide||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm dose escalation study|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Lenalidomide in Combination With Dexamethasone in Anti-MAG Demyelinating Sensorimotor Neuropathy|
|Actual Study Start Date :||September 10, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Lenalidomide escalation and expansion
Among the participants who will be receiving lenalidomide, the first 12 participants will be in the dose escalation phase; with the subsequent 3 participants anticipated to receive dose expansion.
Patients in the dose escalation phase will receive oral treatment with:
Lenalidomide: 10, 15, or 25 mg on Days 1-21 of every 28-day cycle Dexamethasone: 20mg on Days 1,8,15 and 22
Starting doses of Lenalidomide will be assigned at the time of registration.
Once the MTD has been established or determined, 3 additional patients will be treated at the MTD of lenalidomide at the same schedule as above. Dexamethasone will be given at the same dose as in the dose escalation portion of the study.
- MTD [ Time Frame: Treatment duration up to 24 months ]the maximum tolerated dose (MTD) of lenalidomide
- Dose Extension [ Time Frame: Treatment duration up to 24 months ]the recommended dose extension; subsequent to the maximum tolerated dose (MTD) of lenalidomide
- EQ-5D-5L [ Time Frame: Treatment duration up to 24 months ]A self-reported descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems(2), moderate problems(3), severe problems(4) and extreme problems(5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The new version can define 3,125 (=55) different health states. The five figure score represents a 1-5 score in each of 5 domains; the lower the score in each domain the less severe the problems in that domain.
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score [ Time Frame: Treatment duration up to 24 months ]The INCAT (Inflammatory Neuropathy Cause and Treatment) disability score is a measure of activity limitation. It is used frequently as a primary endpoint in inflammatory polyneuropathy clinical trials. The INCAT disability score combines arm and leg disability in a total score ranging from 0 (no signs of disability) to 12 (most severe disability score). It provides a good functional description of the arms and legs in a checklist form suitable for interviewing patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701711
|Contact: Paige Matisak, BSfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Carson Reider, PhD 614-293-9274 email@example.com|
|Principal Investigator:||Bakri Elsheikh, MD||Ohio State University|