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Trial record 18 of 133 for:    Complex Regional Pain Syndrome

Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1 (CRPS-002)

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ClinicalTrials.gov Identifier: NCT00109772
Recruitment Status : Terminated (Interim analysis showed the primary outcome was not reached)
First Posted : May 4, 2005
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Complex Regional Pain Syndrome, Type I
Interventions Drug: lenalidomide
Drug: Placebo
Enrollment 184

Recruitment Details  
Pre-assignment Details A total of 184 participants were randomized to the study and 180 participants received at least 1 dose of study drug.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure. Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Period Title: Double-blind Treatment
Started 90 94
Safety and ITT Population 87 [1] 93 [1]
Completed 68 79
Not Completed 22 15
Reason Not Completed
Adverse Event             14             5
Lack of Efficacy             1             0
Withdrawal by Subject             2             1
Lost to Follow-up             2             3
Protocol Violation             0             1
not specified             0             4
Withdrew prior to treatment             3             1
[1]
Safety: at least one dose of study drug ITT: treated and at least one post dose diary measurement
Period Title: Open-label Extension
Started 64 [1] 78 [2]
Completed 19 [3] 29 [3]
Not Completed 45 49
Reason Not Completed
Adverse Event             10             19
Lack of Efficacy             19             11
Withdrawal by Subject             9             6
Lost to Follow-up             1             0
Death             0             1
Protocol Violation             2             2
not specified             4             10
[1]
Four double-blind participants did not continue into the open-label extension
[2]
One double-blind participant did not continue into the open-label extension
[3]
Participants who were active in extension period when the sponsor terminated the study.
Arm/Group Title Lenalidomide Placebo to Lenalidomide Total
Hide Arm/Group Description 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure. Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure. Total of all reporting groups
Overall Number of Baseline Participants 87 93 180
Hide Baseline Analysis Population Description
Safety population
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 93 participants 180 participants
43.9  (11.37) 45.1  (11.06) 44.5  (11.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
Female
65
  74.7%
79
  84.9%
144
  80.0%
Male
22
  25.3%
14
  15.1%
36
  20.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 93 participants 180 participants
White 81 86 167
Black 3 4 7
Hispanic 1 3 4
Asian/Pacific Islander 2 0 2
1.Primary Outcome
Title Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment
Hide Description Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders.
Time Frame Day 0, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 87 93
Measure Type: Number
Unit of Measure: percentage of participants
Responders 16.1 16.1
Non-responders 83.9 83.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide, Placebo to Lenalidomide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .8940
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments controlled for centers
2.Secondary Outcome
Title Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12
Hide Description Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. Last observation carried forward. Three participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.2  (9.15) -3.0  (9.37)
3.Secondary Outcome
Title Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12
Hide Description Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.65) -0.4  (1.50)
4.Secondary Outcome
Title Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12
Hide Description Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.67) -0.4  (1.53)
5.Secondary Outcome
Title Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12
Hide Description Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.69) -0.4  (1.53)
6.Secondary Outcome
Title Change From Baseline in Daily Sleep Assessment Average Score at Week 12
Hide Description Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7  (1.48) 0.7  (1.42)
7.Secondary Outcome
Title Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12
Hide Description Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (1.08) 0.2  (1.09)
8.Secondary Outcome
Title Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12
Hide Description Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Thirty-three participants had either no baseline or post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 67 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (6.27) -1.4  (5.83)
9.Secondary Outcome
Title Change From Baseline in “Mechanically Evoked” (Allodynia) Numeric Rating Scale (NRS) Score at Week 12
Hide Description The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Sixteen participants had either no baseline or post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 76 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (2.38) -0.1  (2.64)
10.Secondary Outcome
Title Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12
Hide Description The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Fifteen participants were missing values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 76 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.7  (3.23) 4.1  (3.41)
11.Secondary Outcome
Title Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12
Hide Description Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.8  (13.03) -3.7  (12.22)
12.Secondary Outcome
Title Change From Baseline in the Profile of Mood States (POMS) at Week 12
Hide Description Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward. Six participants had no post-treatment values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 84 90
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.6  (33.99) -4.5  (33.91)
13.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Week 12
Hide Description The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. Forty-five participants had no week 12 values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 61 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (1.45) 0.2  (1.41)
14.Secondary Outcome
Title Participants Who Had a Change to CRPS Pain Medication During the Treatment Period
Hide Description Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s).
Time Frame Day 1 to week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 87 93
Measure Type: Number
Unit of Measure: participants
Change to CRPS medication(s) 11 7
No change to CRPS medication 76 86
15.Secondary Outcome
Title Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12
Hide Description An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Fifty participants did not have week 12 values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 57 73
Mean (Standard Deviation)
Unit of Measure: meters/second
0.3  (1.56) 0.1  (2.14)
16.Secondary Outcome
Title Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12
Hide Description An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal sensory nerve conduct velocity.
Time Frame Day 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Fifty participants did not have week 12 values.
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 56 74
Mean (Standard Deviation)
Unit of Measure: meters/second
1.2  (3.51) 0.1  (3.41)
17.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period
Hide Description

Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.

AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.

A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above.

Time Frame Day 1 up to week 158
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description:
10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Overall Number of Participants Analyzed 87 93
Measure Type: Number
Unit of Measure: participants
Adverse event (AE) 83 85
Serious adverse event (SAE) 12 16
AE leading to study drug discontinuation 29 29
AE leading to dose reduction or interruption 10 8
Treatment-related AE 68 66
Treatment-related SAE 1 5
Grade 2 or higher AE 63 68
Grade 3 or higher AE 15 18
Time Frame Day 1 up to week 158, covering both the double-blind treatment and extension periods.
Adverse Event Reporting Description If multiple SAEs were reported within a given preferred term, only one event was counted per subject.
 
Arm/Group Title Lenalidomide Placebo to Lenalidomide
Hide Arm/Group Description 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure. Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
All-Cause Mortality
Lenalidomide Placebo to Lenalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Placebo to Lenalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   12/87 (13.79%)   16/93 (17.20%) 
Blood and lymphatic system disorders     
Hemolytic anemia NOS  1  0/87 (0.00%)  1/93 (1.08%) 
Thrombotic thrombocytopenic purpura  1  0/87 (0.00%)  1/93 (1.08%) 
Cardiac disorders     
Bradycardia NOS  1  0/87 (0.00%)  1/93 (1.08%) 
Sick sinus syndrome  1  1/87 (1.15%)  0/93 (0.00%) 
Endocrine disorders     
Adrenal insufficiency NOS  1  0/87 (0.00%)  1/93 (1.08%) 
Thyroiditis NOS  1  0/87 (0.00%)  1/93 (1.08%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/87 (0.00%)  1/93 (1.08%) 
Vomiting NOS  1  0/87 (0.00%)  1/93 (1.08%) 
General disorders     
Pain NOS  1  1/87 (1.15%)  0/93 (0.00%) 
Hepatobiliary disorders     
Cholecystitis NOS  1  0/87 (0.00%)  1/93 (1.08%) 
Gallbladder obstruction  1  0/87 (0.00%)  1/93 (1.08%) 
Infections and infestations     
Clostridium colitis  1  0/87 (0.00%)  1/93 (1.08%) 
Injury, poisoning and procedural complications     
Joint sprain  1  2/87 (2.30%)  0/93 (0.00%) 
Accidental overdose  1  0/87 (0.00%)  1/93 (1.08%) 
Foot fracture  1  1/87 (1.15%)  0/93 (0.00%) 
Hip fracture  1  0/87 (0.00%)  1/93 (1.08%) 
Investigations     
Blood human chorionic gonadotropin positive  1  1/87 (1.15%)  0/93 (0.00%) 
Blood potassium decreased  1  1/87 (1.15%)  0/93 (0.00%) 
Blood pressure diastolic increased  1  0/87 (0.00%)  1/93 (1.08%) 
Pregnancy test false positive  1  1/87 (1.15%)  0/93 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis NOS  1  1/87 (1.15%)  0/93 (0.00%) 
Nervous system disorders     
Neuropathic pain  1  1/87 (1.15%)  1/93 (1.08%) 
Tremor  1  0/87 (0.00%)  1/93 (1.08%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy NOS  1  2/87 (2.30%)  0/93 (0.00%) 
Abortion spontaneous NOS  1  1/87 (1.15%)  0/93 (0.00%) 
Reproductive system and breast disorders     
Endometriosis  1  0/87 (0.00%)  1/93 (1.08%) 
Respiratory, thoracic and mediastinal disorders     
Alveolitis allergic  1  0/87 (0.00%)  1/93 (1.08%) 
Respiratory failure  1  0/87 (0.00%)  1/93 (1.08%) 
Skin and subcutaneous tissue disorders     
Angioneurotic edema  1  1/87 (1.15%)  0/93 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/87 (1.15%)  2/93 (2.15%) 
Thrombosis  1  1/87 (1.15%)  0/93 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide Placebo to Lenalidomide
Affected / at Risk (%) Affected / at Risk (%)
Total   77/87 (88.51%)   72/93 (77.42%) 
Gastrointestinal disorders     
Nausea  1  14/87 (16.09%)  15/93 (16.13%) 
Diarrhoea NOS  1  11/87 (12.64%)  10/93 (10.75%) 
Constipation  1  8/87 (9.20%)  5/93 (5.38%) 
Vomiting NOS  1  5/87 (5.75%)  4/93 (4.30%) 
General disorders     
Fatigue  1  9/87 (10.34%)  12/93 (12.90%) 
Pyrexia  1  6/87 (6.90%)  4/93 (4.30%) 
Fall  1  3/87 (3.45%)  5/93 (5.38%) 
Infections and infestations     
Urinary tract infection NOS  1  3/87 (3.45%)  6/93 (6.45%) 
Sinusitis NOS  1  5/87 (5.75%)  3/93 (3.23%) 
Investigations     
Alanine aminotransferase increased  1  5/87 (5.75%)  1/93 (1.08%) 
Musculoskeletal and connective tissue disorders     
Muscle cramp  1  5/87 (5.75%)  4/93 (4.30%) 
Nervous system disorders     
Headache  1  9/87 (10.34%)  13/93 (13.98%) 
Dizziness  1  9/87 (10.34%)  6/93 (6.45%) 
Psychiatric disorders     
Insomnia  1  7/87 (8.05%)  5/93 (5.38%) 
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis  1  6/87 (6.90%)  5/93 (5.38%) 
Pharyngitis  1  6/87 (6.90%)  4/93 (4.30%) 
Skin and subcutaneous tissue disorders     
Rash NOS  1  24/87 (27.59%)  9/93 (9.68%) 
Pruritus  1  8/87 (9.20%)  4/93 (4.30%) 
Contusion  1  3/87 (3.45%)  6/93 (6.45%) 
Dry skin  1  6/87 (6.90%)  2/93 (2.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00109772     History of Changes
Other Study ID Numbers: CC-5013-CRPS-002
First Submitted: May 3, 2005
First Posted: May 4, 2005
Results First Submitted: May 7, 2013
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013