Trial Outcomes & Findings for Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance (NCT NCT00665652)

Results Overview

Minimum value of the Total Neuropathy Score is "0", maximum value is "40". A higher score represents a worsening.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Baseline, 12 months

Results posted on

2018-09-11

Participant milestones
Measure	Lenalidomide Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
Overall Study STARTED	8
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Lenalidomide Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
Overall Study Adverse Event	4
Overall Study Death	1
Overall Study No longer met inclusion criteria.	1

Study of Lenalidomide as a Treatment for Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance

Baseline characteristics by cohort
Measure	Lenalidomide n=8 Participants Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

Timeframe: Baseline, 12 months

Population: Subjects were evaluable if they were on study drug for 3 months.

Minimum value of the Total Neuropathy Score is "0", maximum value is "40". A higher score represents a worsening.

Outcome measures
Measure	Lenalidomide n=6 Participants Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.	0.17 units on a scale Interval -4.0 to 5.0

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events
Measure	Lenalidomide n=8 participants at risk Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.
Gastrointestinal disorders Ischemic Colitis	12.5% 1/8 • Number of events 1 • Informed consent obtained through Month 14.
Cardiac disorders Atrial Fibrillation	12.5% 1/8 • Number of events 1 • Informed consent obtained through Month 14.
Blood and lymphatic system disorders Neutropenia	12.5% 1/8 • Number of events 1 • Informed consent obtained through Month 14.

Adverse event data not reported

Dartmouth Hitchcock Medical Center

Phone: 603-650-5104