Trial Outcomes & Findings for Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma (NCT NCT00540007)
NCT ID: NCT00540007
Last Updated: 2017-11-06
Results Overview
* Overall response rate = CR + PR * Definitions per 2007 Cheson Lymphoma Response Criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Through 3.5 years from study entry or until disease progression
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
42
|
|
Overall Study
COMPLETED
|
38
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=42 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
38 years
n=7 Participants
|
36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 3.5 years from study entry or until disease progression* Overall response rate = CR + PR * Definitions per 2007 Cheson Lymphoma Response Criteria
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=42 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL.
|
21.0 percentage of participants
Interval 9.6 to 37.3
|
28.6 percentage of participants
Interval 15.7 to 44.6
|
SECONDARY outcome
Timeframe: 30 days following the completion of treatment* Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 * The higher the grade the worse the adverse event was considered
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=42 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Hyperuricemia
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Neutropenia
|
18 participants
|
20 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Leukopenia
|
11 participants
|
13 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Anemia
|
10 participants
|
4 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Lymphopenia
|
9 participants
|
10 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Thrombocytopenia
|
7 participants
|
8 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Fatigue
|
3 participants
|
2 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Sensory neuropathy
|
2 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Dehydration
|
2 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
AST
|
3 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Infection without neutropenia
|
2 participants
|
3 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Infection with neutropenia
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
ALT
|
2 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Bilirubin
|
2 participants
|
2 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Edema
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Febrile neutropenia
|
1 participants
|
2 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Dyspnea
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Pneumonia
|
0 participants
|
2 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Pleural effusion
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Alkaline phosphatase
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
High potassium
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Confusion
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Dizziness
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Speech impairment
|
0 participants
|
2 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Chest pain
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Extremity pain
|
0 participants
|
2 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Abdominal pain
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Low potassium
|
3 participants
|
3 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Low sodium
|
2 participants
|
2 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Muscle pain
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Secondary malignancy - MDS
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Low albumin
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Low calcium
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
High calcium
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Low phosphorus
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Hearing loss
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Thrombosis/embolism
|
0 participants
|
1 participants
|
|
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Rash
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From 6 months through 3.5 years after study entry* Cytostatic overall response rate = CR + PR + SD greater than or equal to 6 months * Definitions per 2007 Cheson Lymphoma Response Criteria
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=42 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Cytostatic Overall Response Rate
|
15 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Through 3.5 years from study entry or until disease progression-Definitions per 2007 Cheson Lymphoma Response Criteria
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=42 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Participant Response Rate in Relapsed or Refractory cHL.
CR
|
1 Participants
|
3 Participants
|
|
Participant Response Rate in Relapsed or Refractory cHL.
PR
|
7 Participants
|
9 Participants
|
|
Participant Response Rate in Relapsed or Refractory cHL.
SD
|
13 Participants
|
11 Participants
|
|
Participant Response Rate in Relapsed or Refractory cHL.
PD
|
14 Participants
|
14 Participants
|
|
Participant Response Rate in Relapsed or Refractory cHL.
Not evaluable
|
3 Participants
|
4 Participants
|
|
Participant Response Rate in Relapsed or Refractory cHL.
Unknown
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through 3.5 years from study entry or until disease progressionPopulation: (2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.
-Time to progression (TTP) is defined as the time from study entry until documented lymphoma progression or death as a result of lymphoma.
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=40 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Time to Progression (TTP).
|
3.68 months
Interval 2.0 to 19.0
|
4.08 months
Interval 2.0 to 24.0
|
SECONDARY outcome
Timeframe: Through 3.5 years from study entry or until disease progressionPopulation: 1 participant was not evaluable in Cohort 1 and 5 participants were not evaluable in Cohort 2 because these participants did not have death dates or last follow-up dates so overall survival cannot be calculated.
Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause.
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=37 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=37 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
17.434 months
Interval 13.355 to 30.493
|
23.717 months
Interval 17.039 to
There are too few deaths after this time point to define upper limit of the confidence interval unambiguously.
|
SECONDARY outcome
Timeframe: Through 3.5 years from study entry or until disease progressionPopulation: 2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=40 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Relapse Free Survival (RFS)
|
3.78 months
Interval 1.84 to 6.45
|
3.93 months
Interval 1.88 to 6.84
|
SECONDARY outcome
Timeframe: Through 3.5 years from study entry or until disease progressionPopulation: 2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.
-Event-free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=40 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Event Free Survival (EFS).
|
3.78 months
Interval 1.84 to 6.45
|
3.93 months
Interval 1.88 to 6.84
|
SECONDARY outcome
Timeframe: Through 3.5 years from study entry or until disease progressionPopulation: (2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.
-Duration of response: defined as the interval from the date of response (CR or PR) is documented to the date of progression, taking as reference the smallest measurements recorded since the treatment started
Outcome measures
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=40 Participants
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Duration of Response
|
3.68 months
Interval 2.0 to 19.0
|
4.08 months
Interval 2.0 to 24.0
|
Adverse Events
Cohort 1 - Lenalidomide Daily on Days 1-21
Serious events: 9 serious events
Other events: 38 other events
Deaths: 0 deaths
Cohort 2 - Lenalidomide Daily on Days 1-28
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 participants at risk
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=42 participants at risk
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Infections and infestations
Infection with normal ANC (pneumonia)
|
2.6%
1/38
|
2.4%
1/42
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/38
|
2.4%
1/42
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/38
|
2.4%
1/42
|
|
Investigations
Leukopenia
|
0.00%
0/38
|
2.4%
1/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy - MDS
|
0.00%
0/38
|
2.4%
1/42
|
|
Infections and infestations
Infection - lung
|
0.00%
0/38
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/38
|
0.00%
0/42
|
|
General disorders
Fever
|
5.3%
2/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.6%
1/38
|
0.00%
0/42
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/38
|
2.4%
1/42
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
0.00%
0/38
|
2.4%
1/42
|
|
Reproductive system and breast disorders
Pregnancy
|
2.6%
1/38
|
0.00%
0/42
|
|
Eye disorders
Blurred vision
|
0.00%
0/38
|
2.4%
1/42
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/38
|
2.4%
1/42
|
|
Nervous system disorders
Speech impairment
|
0.00%
0/38
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/38
|
2.4%
1/42
|
|
General disorders
Death NOS
|
2.6%
1/38
|
0.00%
0/42
|
|
Cardiac disorders
Chest pain
|
2.6%
1/38
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/38
|
0.00%
0/42
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38
|
0.00%
0/42
|
|
General disorders
General pain
|
0.00%
0/38
|
2.4%
1/42
|
|
Nervous system disorders
Confusion
|
0.00%
0/38
|
2.4%
1/42
|
|
Investigations
Increased bilirubin
|
2.6%
1/38
|
0.00%
0/42
|
Other adverse events
| Measure |
Cohort 1 - Lenalidomide Daily on Days 1-21
n=38 participants at risk
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
|
Cohort 2 - Lenalidomide Daily on Days 1-28
n=42 participants at risk
* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
6/38
|
7.1%
3/42
|
|
Skin and subcutaneous tissue disorders
Abscess
|
0.00%
0/38
|
2.4%
1/42
|
|
Investigations
Alkaline phosphatase
|
28.9%
11/38
|
11.9%
5/42
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
28.9%
11/38
|
19.0%
8/42
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
4/38
|
11.9%
5/42
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint)
|
15.8%
6/38
|
4.8%
2/42
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
5/38
|
11.9%
5/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colon polyps
|
0.00%
0/38
|
2.4%
1/42
|
|
Investigations
Bilirubin
|
13.2%
5/38
|
16.7%
7/42
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
0.00%
0/38
|
2.4%
1/42
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/38
|
4.8%
2/42
|
|
Cardiac disorders
Chest pain
|
0.00%
0/38
|
2.4%
1/42
|
|
General disorders
Chest pain
|
15.8%
6/38
|
9.5%
4/42
|
|
General disorders
Chills
|
7.9%
3/38
|
4.8%
2/42
|
|
Eye disorders
Conjuctivitis
|
0.00%
0/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Constipation
|
34.2%
13/38
|
23.8%
10/42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.6%
12/38
|
35.7%
15/42
|
|
Investigations
Creatinine
|
15.8%
6/38
|
11.9%
5/42
|
|
Skin and subcutaneous tissue disorders
Cutaneous horn, left arm
|
0.00%
0/38
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Diarrhea
|
23.7%
9/38
|
16.7%
7/42
|
|
Musculoskeletal and connective tissue disorders
Diffuse body pain
|
2.6%
1/38
|
0.00%
0/42
|
|
Eye disorders
Diplopia
|
0.00%
0/38
|
2.4%
1/42
|
|
Infections and infestations
Disseminated cryptococcus
|
0.00%
0/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Distension/bloating
|
0.00%
0/38
|
2.4%
1/42
|
|
Nervous system disorders
Dizziness
|
2.6%
1/38
|
16.7%
7/42
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
1/38
|
2.4%
1/42
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.2%
5/38
|
11.9%
5/42
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
0.00%
0/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/38
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (SOB)
|
23.7%
9/38
|
21.4%
9/42
|
|
Ear and labyrinth disorders
Ear pain
|
2.6%
1/38
|
0.00%
0/42
|
|
General disorders
Edema
|
13.2%
5/38
|
14.3%
6/42
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/38
|
4.8%
2/42
|
|
Gastrointestinal disorders
Esophagus pain
|
5.3%
2/38
|
2.4%
1/42
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
10.5%
4/38
|
11.9%
5/42
|
|
Nervous system disorders
Facial numbness
|
2.6%
1/38
|
0.00%
0/42
|
|
General disorders
Fatigue
|
50.0%
19/38
|
42.9%
18/42
|
|
Infections and infestations
Febrile neutropenia
|
2.6%
1/38
|
2.4%
1/42
|
|
General disorders
Fever - no infection
|
10.5%
4/38
|
9.5%
4/42
|
|
Eye disorders
Flashing lights
|
0.00%
0/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Flatulence
|
2.6%
1/38
|
0.00%
0/42
|
|
General disorders
Flu-like syndrome
|
13.2%
5/38
|
0.00%
0/42
|
|
Nervous system disorders
Headache
|
10.5%
4/38
|
11.9%
5/42
|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.5%
23/38
|
50.0%
21/42
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.6%
1/38
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
High calcium
|
5.3%
2/38
|
4.8%
2/42
|
|
Metabolism and nutrition disorders
High glucose
|
18.4%
7/38
|
21.4%
9/42
|
|
Metabolism and nutrition disorders
High magnesium
|
0.00%
0/38
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
High potassium
|
7.9%
3/38
|
4.8%
2/42
|
|
Metabolism and nutrition disorders
High sodium
|
18.4%
7/38
|
0.00%
0/42
|
|
Vascular disorders
Hypertension
|
2.6%
1/38
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/38
|
2.4%
1/42
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.3%
2/38
|
0.00%
0/42
|
|
Vascular disorders
Hypotension
|
2.6%
1/38
|
7.1%
3/42
|
|
Endocrine disorders
Hypothyroidism
|
5.3%
2/38
|
4.8%
2/42
|
|
Infections and infestations
Infection with neutropenia
|
5.3%
2/38
|
4.8%
2/42
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/38
|
2.4%
1/42
|
|
Infections and infestations
Infection without neutropenia
|
31.6%
12/38
|
21.4%
9/42
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/38
|
2.4%
1/42
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/38
|
2.4%
1/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left ovarian cyst
|
0.00%
0/38
|
2.4%
1/42
|
|
Investigations
Leukocytes (WBC)
|
76.3%
29/38
|
76.2%
32/42
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
2.6%
1/38
|
0.00%
0/42
|
|
Nervous system disorders
Loss of balance
|
2.6%
1/38
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Low albumin
|
44.7%
17/38
|
21.4%
9/42
|
|
Metabolism and nutrition disorders
Low calcium
|
28.9%
11/38
|
28.6%
12/42
|
|
Metabolism and nutrition disorders
Low glucose
|
13.2%
5/38
|
4.8%
2/42
|
|
Metabolism and nutrition disorders
Low potassium
|
36.8%
14/38
|
33.3%
14/42
|
|
Metabolism and nutrition disorders
Low sodium
|
31.6%
12/38
|
16.7%
7/42
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.6%
1/38
|
0.00%
0/42
|
|
Vascular disorders
Lymphedema
|
2.6%
1/38
|
0.00%
0/42
|
|
Investigations
Lymphopenia
|
44.7%
17/38
|
50.0%
21/42
|
|
Nervous system disorders
Memory impairment
|
2.6%
1/38
|
2.4%
1/42
|
|
Psychiatric disorders
Mood alteration - Agitation
|
2.6%
1/38
|
0.00%
0/42
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
2.6%
1/38
|
2.4%
1/42
|
|
Psychiatric disorders
Mood alteration - Depression
|
5.3%
2/38
|
2.4%
1/42
|
|
Psychiatric disorders
Mood alteration - NOS
|
2.6%
1/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Mucositis
|
7.9%
3/38
|
4.8%
2/42
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
13.2%
5/38
|
9.5%
4/42
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.6%
1/38
|
16.7%
7/42
|
|
Gastrointestinal disorders
Nausea
|
36.8%
14/38
|
21.4%
9/42
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.5%
4/38
|
4.8%
2/42
|
|
Nervous system disorders
Neuropathic pain
|
5.3%
2/38
|
0.00%
0/42
|
|
Investigations
Neutrophils (ANC)
|
65.8%
25/38
|
66.7%
28/42
|
|
Endocrine disorders
Night sweats
|
0.00%
0/38
|
4.8%
2/42
|
|
Investigations
PTT
|
0.00%
0/38
|
2.4%
1/42
|
|
Skin and subcutaneous tissue disorders
Paleness
|
0.00%
0/38
|
2.4%
1/42
|
|
Investigations
Platelets
|
55.3%
21/38
|
61.9%
26/42
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/38
|
0.00%
0/42
|
|
Infections and infestations
Pneumonia
|
0.00%
0/38
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/38
|
2.4%
1/42
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/38
|
2.4%
1/42
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
18.4%
7/38
|
4.8%
2/42
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.2%
13/38
|
14.3%
6/42
|
|
Investigations
SGOT (AST)
|
26.3%
10/38
|
19.0%
8/42
|
|
Investigations
SGPT (ALT)
|
36.8%
14/38
|
21.4%
9/42
|
|
Skin and subcutaneous tissue disorders
Schleraderma
|
0.00%
0/38
|
2.4%
1/42
|
|
Nervous system disorders
Sensory neuropathy
|
21.1%
8/38
|
9.5%
4/42
|
|
Infections and infestations
Sinusitis
|
0.00%
0/38
|
2.4%
1/42
|
|
Nervous system disorders
Speech impairment
|
0.00%
0/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Stomach pain
|
2.6%
1/38
|
0.00%
0/42
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.00%
0/38
|
2.4%
1/42
|
|
General disorders
Sweating
|
0.00%
0/38
|
7.1%
3/42
|
|
Cardiac disorders
Tachycardia
|
2.6%
1/38
|
0.00%
0/42
|
|
Gastrointestinal disorders
Taste alteration
|
0.00%
0/38
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
0.00%
0/38
|
2.4%
1/42
|
|
Vascular disorders
Thrombosis/embolism
|
0.00%
0/38
|
2.4%
1/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroglossal duct cyst
|
0.00%
0/38
|
2.4%
1/42
|
|
General disorders
Tumor flare
|
2.6%
1/38
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/38
|
2.4%
1/42
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/38
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes (hoarseness)
|
0.00%
0/38
|
2.4%
1/42
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
7/38
|
4.8%
2/42
|
|
Eye disorders
Watery eyes
|
2.6%
1/38
|
0.00%
0/42
|
|
Investigations
Weight gain
|
0.00%
0/38
|
2.4%
1/42
|
|
Investigations
Weight loss
|
10.5%
4/38
|
9.5%
4/42
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
1/38
|
4.8%
2/42
|
Additional Information
Todd Fehniger, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-747-1385
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place