Trial Outcomes & Findings for A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients (NCT NCT00699842)
NCT ID: NCT00699842
Last Updated: 2025-05-04
Results Overview
Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in \>10mg doses of lenalidomide
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
2 years
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Lenalidomide (15mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (20mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (25mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
0
|
|
Overall Study
COMPLETED
|
3
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lenalidomide (15mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (20mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (25mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients
Baseline characteristics by cohort
| Measure |
Lenalidomide (15mg)
n=3 Participants
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (20mg)
n=5 Participants
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (25mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.38 years
STANDARD_DEVIATION 20.06 • n=5 Participants
|
65.98 years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
—
|
62.76 years
STANDARD_DEVIATION 14.29 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
—
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDetermine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in \>10mg doses of lenalidomide
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsSafety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.
Outcome measures
Outcome data not reported
Adverse Events
Lenalidomide (15mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lenalidomide (20mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lenalidomide (25mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lenalidomide (15mg)
n=3 participants at risk
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (20mg)
n=5 participants at risk
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
Lenalidomide (25mg)
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Lenalidomide: Dose Level Lenalidomide Schedule
1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days
|
|---|---|---|---|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4
|
80.0%
4/5 • Number of events 4
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Nervous system disorders
Numbness/tingling
|
100.0%
3/3 • Number of events 4
|
60.0%
3/5 • Number of events 3
|
—
0/0
|
|
General disorders
Hoarseness
|
66.7%
2/3 • Number of events 2
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Swelling in legs
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
66.7%
2/3 • Number of events 5
|
40.0%
2/5 • Number of events 3
|
—
0/0
|
|
Renal and urinary disorders
Awakening to urinate
|
100.0%
3/3 • Number of events 4
|
60.0%
3/5 • Number of events 3
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Pale skin
|
33.3%
1/3 • Number of events 3
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Weakness
|
66.7%
2/3 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Insomnia
|
66.7%
2/3 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
General disorders
Post nasal drip
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Muscle ache/pain
|
100.0%
3/3 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Sore throat
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Cough with sputum production
|
66.7%
2/3 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Joint pain/stiffness
|
33.3%
1/3 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
—
0/0
|
|
General disorders
Problems with balance/dizziness
|
33.3%
1/3 • Number of events 2
|
20.0%
1/5 • Number of events 2
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Painful breathing
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
66.7%
2/3 • Number of events 2
|
0.00%
0/5
|
—
0/0
|
|
Blood and lymphatic system disorders
Elevated blood pressure
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Swollen glands/lumps
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Lack of energy/lack of motivation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Itching
|
66.7%
2/3 • Number of events 2
|
80.0%
4/5 • Number of events 4
|
—
0/0
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2
|
80.0%
4/5 • Number of events 4
|
—
0/0
|
|
General disorders
Achiness under armpit
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Back pain
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Pain in arm at injection site
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Headache
|
33.3%
1/3 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Cough
|
33.3%
1/3 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Sweats
|
33.3%
1/3 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
General disorders
Sinus pain/congestion
|
33.3%
1/3 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
Eye disorders
Dry eyes
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
—
0/0
|
|
General disorders
Nausea
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Vomiting
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Change in appetite
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
General disorders
Weight loss
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Dry mouth/sores
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Shakiness
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Lesions
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Psychiatric disorders
Memory changes
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Eye disorders
Change in vision
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Eye disorders
Itching of eyes
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Alopecia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Hip pain
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Tired
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Red spots on leg
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Renal and urinary disorders
Burning after urination
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Dark urine
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Swollen foot
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Raised bumps on neck
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Lightheadedness
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Chills
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Dehydration
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
Eye disorders
Light flashes in right eye
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Pimple/boil
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Scattered rales
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Pain in right hemithorax
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
—
0/0
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Shoulder pain
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Infection
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Swollen abdomen
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Achiness
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Tooth abscess
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
General disorders
Bone pain
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place