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Trial record 66 of 498 for:    LENALIDOMIDE AND every 28 days

Study of 2 Different Doses of Revlimid in Biochemically Relapse Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00348595
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Revlimid
Enrollment 77
Recruitment Details  
Pre-assignment Details 17 subjects were screen failures
Arm/Group Title Revlimid 5mg/Day Revlimid 25mg/Day
Hide Arm/Group Description One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles). One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Period Title: Overall Study
Started 26 34
Completed 21 26
Not Completed 5 8
Reason Not Completed
Adverse Event             5             8
Arm/Group Title Revlimid 5mg/Day Revlimid 25mg/Day Total
Hide Arm/Group Description One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol. One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol. Total of all reporting groups
Overall Number of Baseline Participants 26 34 60
Hide Baseline Analysis Population Description
Baseline characteristics were only recorded for patients who entered the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 34 participants 60 participants
63.7  (7.1) 63.1  (7.2) 63.4  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 34 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
26
 100.0%
34
 100.0%
60
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 34 participants 60 participants
26 34 60
Gleason score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 34 participants 60 participants
7.1  (1.0) 7.3  (1.1) 7.2  (1.05)
[1]
Measure Description: The Gleason score ranges from 2-10 with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5).
Local therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Radical prostatectomy Number Analyzed 26 participants 34 participants 60 participants
12
  46.2%
12
  35.3%
24
  40.0%
Radiation therapy Number Analyzed 26 participants 34 participants 60 participants
4
  15.4%
8
  23.5%
12
  20.0%
Surgery and Radiation therapy Number Analyzed 26 participants 34 participants 60 participants
10
  38.5%
14
  41.2%
24
  40.0%
Prior androgen deprivation therapy Number Analyzed 26 participants 34 participants 60 participants
8
  30.8%
11
  32.4%
19
  31.7%
Serum testosterone  
Mean (Full Range)
Unit of measure:  (ng/dL)
Number Analyzed 26 participants 34 participants 60 participants
374
(148 to 564)
342
(175 to 569)
358
(148 to 569)
Prostate Specific Antigen (PSA)  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 26 participants 34 participants 60 participants
11.9  (11.9) 12.4  (13.6) 12.2  (12.8)
PSA doubling time (PSADT)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 34 participants 60 participants
< 3 months
6
  23.1%
10
  29.4%
16
  26.7%
3-8.9 months
13
  50.0%
16
  47.1%
29
  48.3%
≥ 9 months
7
  26.9%
8
  23.5%
15
  25.0%
Pre-treatment PSA slopes  
Mean (Full Range)
Unit of measure:  Log PSA/month
Number Analyzed 26 participants 34 participants 60 participants
0.16
(0.11 to 0.21)
0.18
(0.13 to 0.23)
0.17
(0.11 to 0.23)
1.Primary Outcome
Title Safety, Feasibility and Tolerance of Revlimid as Assessed by Number of Participants Experiencing Grade 3 and 4 Adverse Events.
Hide Description Number of participants experiencing Grade 3 and 4 adverse events as defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Time Frame 6 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid 5mg/Day Revlimid 25mg/Day
Hide Arm/Group Description:
One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Overall Number of Participants Analyzed 26 34
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.5%
10
  29.4%
2.Primary Outcome
Title Number of Participants With Prostate-specific Antigen (PSA) Progression
Hide Description Number of participants with greater than or equal to 25% increase in PSA at 6 months
Time Frame 6 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid 5mg/Day Revlimid 25mg/Day
Hide Arm/Group Description:
One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Overall Number of Participants Analyzed 26 34
Measure Type: Count of Participants
Unit of Measure: Participants
7
  26.9%
5
  14.7%
3.Primary Outcome
Title Change in of PSA Slope
Hide Description Mean change in PSA slope from baseline to 6 months. PSA slope was calculated using the regression of log PSA over 6 months in each patient. A negative mean change in PSA slope reflects a better outcome.
Time Frame Change from baseline to 6 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid 5mg/Day Revlimid 25mg/Day
Hide Arm/Group Description:
One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Overall Number of Participants Analyzed 26 34
Mean (95% Confidence Interval)
Unit of Measure: log PSA
-0.033
(-0.11 to 0.04)
-0.172
(-0.24 to -0.11)
4.Secondary Outcome
Title Plasma Concentration of Revilimid at Steady State
Hide Description Mean plasma concentration (ng/mL) of Revilimid at steady state (Day 21 of second treatment cycle)
Time Frame Day 21 of second treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Data was only evaluable in 20/26 and 27/34 participants from the 5mg and 25mg arms, respectively.
Arm/Group Title Revlimid 5mg/Day Revlimid 25mg/Day
Hide Arm/Group Description:
One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles).
Overall Number of Participants Analyzed 20 27
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
12.67
(6.1 to 19.2)
65.14
(24.3 to 106.0)
Time Frame Collected monthly, up to 44 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Revlimid 5mg/Day Revlimid 25mg/Day
Hide Arm/Group Description One 5 mg active Revlimid capsule and one 25 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol. One 25 mg active Revlimid capsule and one 5 mg matched placebo capsule given by mouth daily in the morning (at approximately the same time) on days 1-21 (28-day cycles), repeated monthly for 6 months or until dose-limiting toxicity or disease progression, as defined in the protocol.
All-Cause Mortality
Revlimid 5mg/Day Revlimid 25mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      0/34 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Revlimid 5mg/Day Revlimid 25mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/26 (11.54%)      10/34 (29.41%)    
Blood and lymphatic system disorders     
Neutropenia  1  0/26 (0.00%)  0 5/34 (14.71%)  5
Nervous system disorders     
Fatigue  1  1/26 (3.85%)  1 1/34 (2.94%)  1
Skin and subcutaneous tissue disorders     
Severe Rash  1  0/26 (0.00%)  0 2/34 (5.88%)  2
Vascular disorders     
venous thromboembolism  1  2/26 (7.69%)  2 2/34 (5.88%)  2
1
Term from vocabulary, CTCAE v3.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Revlimid 5mg/Day Revlimid 25mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/26 (100.00%)      34/34 (100.00%)    
Blood and lymphatic system disorders     
anemia  1  7/26 (26.92%)  7 10/34 (29.41%)  10
Lymphopenia  1  1/26 (3.85%)  1 8/34 (23.53%)  8
Neutropenia  1  5/26 (19.23%)  5 9/34 (26.47%)  9
Thrombocytopenia  1  4/4 (100.00%)  4 8/34 (23.53%)  8
Eye disorders     
Blurred Vision  1  1/26 (3.85%)  1 2/34 (5.88%)  2
Dry Eye  1  2/26 (7.69%)  2 2/34 (5.88%)  2
Gastrointestinal disorders     
Constipation  1  10/26 (38.46%)  10 15/34 (44.12%)  15
Dysphagia  1  0/26 (0.00%)  0 5/34 (14.71%)  5
Anal Pain  1  1/26 (3.85%)  1 0/34 (0.00%)  0
Abdominal Pain  1  3/26 (11.54%)  3 6/34 (17.65%)  6
Diarrhea  1  2/26 (7.69%)  2 5/34 (14.71%)  5
Dry Mouth * 1  1/26 (3.85%)  1 5/34 (14.71%)  5
Investigations     
Increased of SGOT  1  2/26 (7.69%)  2 8/34 (23.53%)  8
Metabolism and nutrition disorders     
Hyperglycemia  1  11/26 (42.31%)  11 14/34 (41.18%)  14
Musculoskeletal and connective tissue disorders     
Back Pain  1  4/26 (15.38%)  4 2/34 (5.88%)  2
Nervous system disorders     
Fatigue  1  12/26 (46.15%)  12 29/34 (85.29%)  29
Muscular Cramping  1 [1]  5/26 (19.23%)  5 14/34 (41.18%)  14
Dizziness  1  4/26 (15.38%)  4 5/34 (14.71%)  5
Headache  1  4/26 (15.38%)  4 5/34 (14.71%)  5
Psychiatric disorders     
Depression  1  0/26 (0.00%)  0 1/34 (2.94%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/26 (7.69%)  2 5/34 (14.71%)  5
Skin and subcutaneous tissue disorders     
Pruritus  1  8/26 (30.77%)  8 15/34 (44.12%)  15
Rash  1  7/26 (26.92%)  7 15/34 (44.12%)  15
Alopecia  1  0/26 (0.00%)  0 5/34 (14.71%)  5
Dry Skin  1  4/26 (15.38%)  4 5/34 (14.71%)  5
Vascular disorders     
Flushing  1 [2]  0/26 (0.00%)  0 4/34 (11.76%)  4
1
Term from vocabulary, CTCAE v3.0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Leg and or Hand
[2]
Facial Flushing
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mario Eisenberger
Organization: Johns Hopkins University School of Medicine
Phone: (410) 614-3511
EMail: eisenma@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00348595     History of Changes
Other Study ID Numbers: J0798
RV-PCA-PI-069
NA_00013597 ( Other Identifier: JHM IRB )
J0798 ( Other Identifier: JHM IRB )
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: March 21, 2019
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019