Trial Outcomes & Findings for Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain (NCT NCT00684242)

Last Updated: 2013-01-28

Results Overview

Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 "no symptom" to 10 "worst possible symptom."

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

From baseline to Day 15

Results posted on

2013-01-28

Participant Flow

Recruitment Period: May 22, 2008 to November 1, 2010. All recruitment done at UT MD Anderson Cancer Center.

One participant was enrolled but excluded from the trial before assignment to groups.

Participant milestones

Participant milestones
Measure	Lenalidomide 10 mg by mouth daily
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide n=3 Participants 10 mg by mouth daily
Age Continuous	64 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to Day 15

Population: One participant was not evaluable for Day 15.

Outcome measures

Outcome measures
Measure	Lenalidomide n=2 Participants 10 mg by mouth daily
Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS) Participant 1	0 units on a scale
Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS) Participant 2	-2 units on a scale

Adverse Events

Lenalidomide

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide n=3 participants at risk 10 mg by mouth daily
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • 1 year and 8 months
General disorders Fatigue	33.3% 1/3 • Number of events 1 • 1 year and 8 months
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • 1 year and 8 months
General disorders Pain (Extremity-Limb)	33.3% 1/3 • Number of events 1 • 1 year and 8 months

Other adverse events

Other adverse events
Measure	Lenalidomide n=3 participants at risk 10 mg by mouth daily
Gastrointestinal disorders Constipation	66.7% 2/3 • Number of events 6 • 1 year and 8 months
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 2 • 1 year and 8 months
General disorders Dry Mouth	66.7% 2/3 • Number of events 3 • 1 year and 8 months
General disorders Fatigue	100.0% 3/3 • Number of events 9 • 1 year and 8 months
General disorders Insomnia	66.7% 2/3 • Number of events 3 • 1 year and 8 months
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 8 • 1 year and 8 months
Gastrointestinal disorders Pain (Extremity-Limb)	33.3% 1/3 • Number of events 1 • 1 year and 8 months
General disorders Pain (NOS)	33.3% 1/3 • Number of events 1 • 1 year and 8 months
Skin and subcutaneous tissue disorders Rash/Desquamation	33.3% 1/3 • Number of events 2 • 1 year and 8 months
General disorders Somnolence	66.7% 2/3 • Number of events 3 • 1 year and 8 months
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • 1 year and 8 months
Eye disorders Watery Eye	66.7% 2/3 • Number of events 3 • 1 year and 8 months

Additional Information

Sriram Yennurajalingam, MD / Assistant Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place