Trial Outcomes & Findings for Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma (NCT NCT01057121)
NCT ID: NCT01057121
Last Updated: 2022-02-08
Results Overview
Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
28 days
Results posted on
2022-02-08
Participant Flow
Participant milestones
| Measure |
Phase I: Treatment (Lenalidomide) , 10 mg/Day
Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
Phase I: Treatment (Lenalidomide), 15 mg/Day
Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
Phase I, Treatment Ienalidomide), 20 mg/Day
Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
Phase I: Treatment (Lenalidomide), 25 mg/Day
Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
Phase II: Treatment (Lenalidomide), 25 mg/Day
Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Phase I: 10 mg/Day Lenalidomide
STARTED
|
3
|
0
|
0
|
0
|
0
|
|
Phase I: 10 mg/Day Lenalidomide
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Phase I: 10 mg/Day Lenalidomide
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: 15 mg/Day Lenolidomide
STARTED
|
0
|
3
|
0
|
0
|
0
|
|
Phase I: 15 mg/Day Lenolidomide
COMPLETED
|
0
|
3
|
0
|
0
|
0
|
|
Phase I: 15 mg/Day Lenolidomide
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: 20 mg/Day Lenalidomide
STARTED
|
0
|
0
|
3
|
0
|
0
|
|
Phase I: 20 mg/Day Lenalidomide
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
|
Phase I: 20 mg/Day Lenalidomide
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: 25 mg/Day Lenalidomide
STARTED
|
0
|
0
|
0
|
6
|
0
|
|
Phase I: 25 mg/Day Lenalidomide
COMPLETED
|
0
|
0
|
0
|
6
|
0
|
|
Phase I: 25 mg/Day Lenalidomide
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase II: 25 mg/Day Lenalidomide
STARTED
|
0
|
0
|
0
|
0
|
23
|
|
Phase II: 25 mg/Day Lenalidomide
COMPLETED
|
0
|
0
|
0
|
0
|
23
|
|
Phase II: 25 mg/Day Lenalidomide
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma
Baseline characteristics by cohort
| Measure |
Phase I - Treatment (Lenalidomide)
n=15 Participants
Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase II - Treatment (Lenalidomide)
n=23 Participants
Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
46.9 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 9.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
23 participants
n=4 Participants
|
38 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Only patients in the phase I portion of the study were evaluated for this outcome measure.
Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
Outcome measures
| Measure |
Phase I - Treatment (Lenalidomide)
n=15 Participants
Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)
|
Phase I - 15 mg/Day (Lenalidomide)
Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 20 mg/Day Lenalidomide
Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 25 mg/Day Lenalidomide
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase II: 25 mg/Day Lenalidomide
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)
|
25 mg per day of lenalidomide
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days after completion of study treatmentPopulation: Patients who were evaluable for response. To be evaluable for response, the patient had to complete at least one cycle of treatment.
Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks. Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.
Outcome measures
| Measure |
Phase I - Treatment (Lenalidomide)
n=3 Participants
Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)
|
Phase I - 15 mg/Day (Lenalidomide)
n=3 Participants
Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 20 mg/Day Lenalidomide
n=2 Participants
Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 25 mg/Day Lenalidomide
n=5 Participants
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase II: 25 mg/Day Lenalidomide
n=19 Participants
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
|---|---|---|---|---|---|
|
Tumor Response Rate
|
0 percent of participants who responded
Interval 0.0 to 0.0
|
0 percent of participants who responded
Interval 0.0 to 0.0
|
50 percent of participants who responded
Interval 1.0 to 99.0
|
80 percent of participants who responded
Interval 28.0 to 99.0
|
53 percent of participants who responded
Interval 30.0 to 75.0
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentPopulation: Study participants who died on study.
Percentage of patients who died
Outcome measures
| Measure |
Phase I - Treatment (Lenalidomide)
n=3 Participants
Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)
|
Phase I - 15 mg/Day (Lenalidomide)
n=3 Participants
Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 20 mg/Day Lenalidomide
n=3 Participants
Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 25 mg/Day Lenalidomide
n=6 Participants
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase II: 25 mg/Day Lenalidomide
n=23 Participants
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
|---|---|---|---|---|---|
|
Time to Death
|
0 percentage of participants who died
|
0 percentage of participants who died
|
0 percentage of participants who died
|
0 percentage of participants who died
|
0 percentage of participants who died
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentPopulation: Patients who relapsed
Percentage of participants who relapsed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentPopulation: Participants who had a complete or partial responses
time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.
Outcome measures
| Measure |
Phase I - Treatment (Lenalidomide)
Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)
|
Phase I - 15 mg/Day (Lenalidomide)
Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 20 mg/Day Lenalidomide
n=1 Participants
Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 25 mg/Day Lenalidomide
n=4 Participants
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase II: 25 mg/Day Lenalidomide
n=10 Participants
Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
|---|---|---|---|---|---|
|
Time to Response
|
—
|
—
|
8 weeks
Interval 8.0 to 8.0
|
20.5 weeks
Interval 12.0 to 28.0
|
13 weeks
Interval 4.0 to 38.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after completion of study treatmentPopulation: The KSHV (HHV-8) assays were run, but the results were unreliable.
Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration.
Outcome measures
Outcome data not reported
Adverse Events
Phase I: 10 mg/Day Lenalidomide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: 15 mg/Day Lenalidomide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: 20 mg/Day Lenalidomide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I and II: 25 mg/Day Lenalidomide
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: 10 mg/Day Lenalidomide
n=3 participants at risk
Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 15 mg/Day Lenalidomide
n=3 participants at risk
Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 20 mg/Day Lenalidomide
n=3 participants at risk
Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I and II: 25 mg/Day Lenalidomide
n=29 participants at risk
Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
|---|---|---|---|---|
|
Infections and infestations
Lung Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29 • Number of events 2
|
|
Infections and infestations
Meningitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Phase I: 10 mg/Day Lenalidomide
n=3 participants at risk
Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 15 mg/Day Lenalidomide
n=3 participants at risk
Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I: 20 mg/Day Lenalidomide
n=3 participants at risk
Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
Phase I and II: 25 mg/Day Lenalidomide
n=29 participants at risk
Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
24.1%
7/29
|
|
Blood and lymphatic system disorders
Blood and Lymphatic disorders, other
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/29
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
20.7%
6/29
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
44.8%
13/29
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
3.4%
1/29
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
20.7%
6/29
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
13.8%
4/29
|
|
General disorders
Edema - limbs
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
10.3%
3/29
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
66.7%
2/3
|
55.2%
16/29
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Immune system disorders
Allergic reaction
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
3.4%
1/29
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
33.3%
1/3
|
66.7%
2/3
|
41.4%
12/29
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3
|
0.00%
0/3
|
17.2%
5/29
|
|
Investigations
Weight loss
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
3.4%
1/29
|
|
Investigations
White blood cell decreased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
20.7%
6/29
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
10.3%
3/29
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
10.3%
3/29
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
10.3%
3/29
|
|
Metabolism and nutrition disorders
Metaolism and nutrition disorders, other
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
6.9%
2/29
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
27.6%
8/29
|
|
Nervous system disorders
Nervous system disorder, other
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
3.4%
1/29
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29
|
|
Nervous system disorders
Anxiety
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
1/29
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
10.3%
3/29
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
10.3%
3/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
13.8%
4/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
17.2%
5/29
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3
|
0.00%
0/3
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
27.6%
8/29
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
34.5%
10/29
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, other
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
20.7%
6/29
|
|
Vascular disorders
Lymphedema
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
6.9%
2/29
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/29
|
|
Investigations
Creatinine Increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/29
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/29
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/29
|
|
Investigations
Investigations, other
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60