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Trial record 30 of 491 for:    LENALIDOMIDE AND every 28 days

Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients

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ClinicalTrials.gov Identifier: NCT00654186
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : February 28, 2014
Last Update Posted : March 28, 2014
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Revlimid
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Revlimid Oral for 21days
Hide Arm/Group Description Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
Period Title: Overall Study
Started 32
Completed 27
Not Completed 5
Reason Not Completed
Withdrawal by Subject             5
Arm/Group Title Revlimid Oral for 21days
Hide Arm/Group Description Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
32 patients started the study. 27 patients had two or mor cycles of study medication. 5 patients withdrew from the study before completing one cycle, making them not evaluable for response
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  25.0%
>=65 years
24
  75.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
0
   0.0%
Male
32
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants
Hide Description

The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as > or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined < a 30% decrease in the sum of the longest diameter of measureable lesions and < a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions.

Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA < or equal to 4 ng/dl. A PSA PR was a PSA that decreased by > or equal to 50%. Stable PSA was defined as a PSA that increased >25% and decreased < 50%.

Time Frame 24 months for acrual
Hide Outcome Measure Data
Hide Analysis Population Description
evaluable patients
Arm/Group Title Revlimid Oral for 21days
Hide Arm/Group Description:
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: percentage of patients
74
2.Secondary Outcome
Title Time to PSA Progression
Hide Description As defined in the protocol PSA progression was an increase of at least 25%
Time Frame 24 months for acrual
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid Oral for 21days
Hide Arm/Group Description:
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
Overall Number of Participants Analyzed 27
Median (Full Range)
Unit of Measure: months
3
(2 to 11)
3.Secondary Outcome
Title Time to Disesase Progression as Measured by Radiographic Progression
Hide Description Progressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0. PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid Oral for 21days
Hide Arm/Group Description:
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
Overall Number of Participants Analyzed 27
Median (Full Range)
Unit of Measure: months
4
(2 to 16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Revlimid Orally for 21 Days
Hide Arm/Group Description Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
All-Cause Mortality
Revlimid Orally for 21 Days
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Revlimid Orally for 21 Days
Affected / at Risk (%) # Events
Total   14/32 (43.75%)    
Blood and lymphatic system disorders   
diverticulitis   1/32 (3.13%)  1
Cardiac disorders   
atrial fibrilation   2/32 (6.25%)  2
myocardial infarction   1/32 (3.13%)  1
Gastrointestinal disorders   
pancreatitis   1/32 (3.13%)  1
dehydration   4/32 (12.50%)  4
rectal abcess   1/32 (3.13%)  1
General disorders   
weakness   1/32 (3.13%)  1
pancytopenia   1/32 (3.13%)  1
Hepatobiliary disorders   
cholecystitis   1/32 (3.13%)  1
Infections and infestations   
sepsis   1/32 (3.13%)  1
bronchitis   1/32 (3.13%)  1
Nervous system disorders   
syncope   2/32 (6.25%)  2
Renal and urinary disorders   
renal failure   1/32 (3.13%)  1
kidney stones   1/32 (3.13%)  1
Hematuria   2/32 (6.25%)  2
Respiratory, thoracic and mediastinal disorders   
respiratory failure   1/32 (3.13%)  1
pulmonary embolism   2/32 (6.25%)  2
exacerbation of chronic obstructive pulmonary disorder   1/32 (3.13%)  1
Shortness of breath   1/32 (3.13%)  1
Skin and subcutaneous tissue disorders   
rash   1/32 (3.13%)  1
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 5%
Revlimid Orally for 21 Days
Affected / at Risk (%) # Events
Total   32/32 (100.00%)    
Blood and lymphatic system disorders   
anemia   22/32 (68.75%) 
bruises easily   8/32 (25.00%) 
bleeds easily   2/32 (6.25%) 
leukopenia   18/32 (56.25%) 
lymphopenia   12/32 (37.50%) 
neutropenia   18/32 (56.25%) 
thrombocytopenia   20/32 (62.50%) 
Cardiac disorders   
atrial fibrilation   2/32 (6.25%) 
congestive heart failure   2/32 (6.25%) 
hypertension   2/32 (6.25%) 
tachycardia   5/32 (15.63%) 
Endocrine disorders   
hypoglycemia   2/32 (6.25%) 
hyperglycemia   13/32 (40.63%) 
Eye disorders   
eyes dry   3/32 (9.38%) 
eyes watery   3/32 (9.38%) 
vision problems   2/32 (6.25%) 
vision changes   3/32 (9.38%) 
Gastrointestinal disorders   
albumin low   20/32 (62.50%) 
anorexia   16/32 (50.00%) 
constipation   29/32 (90.63%) 
diarrhea   8/32 (25.00%) 
diverticulitis   3/32 (9.38%) 
dehydration   6/32 (18.75%) 
mouth dry   4/32 (12.50%) 
mouth sores   2/32 (6.25%) 
nausea   7/32 (21.88%) 
taste changes   6/32 (18.75%) 
vomiting   5/32 (15.63%) 
General disorders   
bloating   3/32 (9.38%) 
chills   5/32 (15.63%) 
dizziness   3/32 (9.38%) 
edema   7/32 (21.88%) 
fatigue   23/32 (71.88%) 
gynecomastia   3/32 (9.38%) 
globulin low   2/32 (6.25%) 
headache   3/32 (9.38%) 
insomnia   5/32 (15.63%) 
lightheadedness   5/32 (15.63%) 
leg weakness   2/32 (6.25%) 
pain   5/32 (15.63%) 
syncope   2/32 (6.25%) 
throat sore   3/32 (9.38%) 
weight loss   11/32 (34.38%) 
weakness   5/32 (15.63%) 
Hepatobiliary disorders   
aspartate aminotransferase increased   7/32 (21.88%) 
alanine aminotransferase   6/32 (18.75%) 
Alkaline phosphatase   9/32 (28.13%) 
Infections and infestations   
unrinary tract infection   3/32 (9.38%) 
Metabolism and nutrition disorders   
hyperkalemia   4/32 (12.50%) 
hypokalemia   7/32 (21.88%) 
hypotremia   8/32 (25.00%) 
hypocalcemia   12/32 (37.50%)  12
Musculoskeletal and connective tissue disorders   
arthalgia   7/32 (21.88%) 
back pain   7/32 (21.88%) 
cramps   2/32 (6.25%) 
hip pain   2/32 (6.25%) 
neck sore   2/32 (6.25%) 
shoulder pain   3/32 (9.38%) 
Nervous system disorders   
neuropathy motor   7/32 (21.88%) 
neuropathy sensory   3/32 (9.38%) 
Psychiatric disorders   
anxiety   9/32 (28.13%) 
depression   10/32 (31.25%) 
Renal and urinary disorders   
bilirubin increased   2/32 (6.25%) 
creatinine increased   6/32 (18.75%) 
hematuria   4/32 (12.50%) 
renal insufficiency   3/32 (9.38%) 
urinary frequency increased   3/32 (9.38%) 
Reproductive system and breast disorders   
hot flashes   2/32 (6.25%) 
libido decreased   4/32 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
cough   3/32 (9.38%) 
dyspnea on exertion   5/32 (15.63%) 
pulmonary emboli   2/32 (6.25%) 
shortness of breath   6/32 (18.75%) 
wheezing   2/32 (6.25%) 
Skin and subcutaneous tissue disorders   
itching   3/32 (9.38%) 
rash   12/32 (37.50%) 
skin dry   6/32 (18.75%) 
Indicates events were collected by systematic assessment
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: Sigrun Hallmeyer, MD
Organization: Oncology Specialists, SC
Phone: 847-268-8200
EMail: shallmeyer@oncmed.net
Layout table for additonal information
Responsible Party: Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00654186     History of Changes
Other Study ID Numbers: RV-PCA-PI-327
First Submitted: April 2, 2008
First Posted: April 7, 2008
Results First Submitted: January 15, 2014
Results First Posted: February 28, 2014
Last Update Posted: March 28, 2014