Trial Outcomes & Findings for Lenalidomide for Patients With Myelofibrosis (MF) (NCT NCT00352794)
NCT ID: NCT00352794
Last Updated: 2019-07-23
Results Overview
Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2019-07-23
Participant Flow
Recruitment Period: July 2006 - April 2007
Participant milestones
| Measure |
Lenalidomide + Prednisone
Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle
Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide for Patients With Myelofibrosis (MF)
Baseline characteristics by cohort
| Measure |
Lenalidomide + Prednisone
n=40 Participants
Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle
Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTime to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death.
Outcome measures
| Measure |
Lenalidomide + Prednisone
n=40 Participants
Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle
Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
|
|---|---|
|
Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)
|
14 Participants
|
Adverse Events
Lenalidomide + Prednisone
Serious events: 7 serious events
Other events: 40 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Lenalidomide + Prednisone
n=40 participants at risk
Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle
Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
|
|---|---|
|
General disorders
Abdominal Pain
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
|
General disorders
Back Pain
|
2.5%
1/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
Gastrointestinal disorders
Cholecystitis
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
|
General disorders
Death
|
7.5%
3/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
General disorders
Fatigue
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
|
Blood and lymphatic system disorders
Increased Transaminase
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
|
Infections and infestations
Infection
|
7.5%
3/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
Surgical and medical procedures
Mitral Heart Valve Repair
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
|
Surgical and medical procedures
Stent Replacement
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
|
General disorders
West Nile Virus
|
2.5%
1/40 • Number of events 1 • For at least 6 cycles, and up to 11 years
|
Other adverse events
| Measure |
Lenalidomide + Prednisone
n=40 participants at risk
Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle
Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
52.5%
21/40 • Number of events 33 • For at least 6 cycles, and up to 11 years
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
15/40 • Number of events 17 • For at least 6 cycles, and up to 11 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.5%
9/40 • Number of events 11 • For at least 6 cycles, and up to 11 years
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
7.5%
3/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
General disorders
fatigue
|
35.0%
14/40 • Number of events 14 • For at least 6 cycles, and up to 11 years
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
12/40 • Number of events 14 • For at least 6 cycles, and up to 11 years
|
|
Infections and infestations
Infection
|
42.5%
17/40 • Number of events 24 • For at least 6 cycles, and up to 11 years
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
10.0%
4/40 • Number of events 4 • For at least 6 cycles, and up to 11 years
|
|
Blood and lymphatic system disorders
Edema
|
20.0%
8/40 • Number of events 8 • For at least 6 cycles, and up to 11 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
6/40 • Number of events 6 • For at least 6 cycles, and up to 11 years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Nervous system disorders
Depression
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Gastrointestinal disorders
Heartburn
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Number of events 2 • For at least 6 cycles, and up to 11 years
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
Hepatobiliary disorders
Increased Transaminase
|
5.0%
2/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
General disorders
Sweating
|
7.5%
3/40 • Number of events 3 • For at least 6 cycles, and up to 11 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
4/40 • Number of events 4 • For at least 6 cycles, and up to 11 years
|
|
General disorders
Headache
|
10.0%
4/40 • Number of events 4 • For at least 6 cycles, and up to 11 years
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • Number of events 4 • For at least 6 cycles, and up to 11 years
|
|
Nervous system disorders
Neuropathy
|
10.0%
4/40 • Number of events 4 • For at least 6 cycles, and up to 11 years
|
|
General disorders
Pain
|
52.5%
21/40 • Number of events 27 • For at least 6 cycles, and up to 11 years
|
|
Blood and lymphatic system disorders
Decreased White Blood Count
|
55.0%
22/40 • Number of events 35 • For at least 6 cycles, and up to 11 years
|
Additional Information
Dr. Srdan Verstovsek, MD., Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-3429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place