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Trial record 70 of 494 for:    LENALIDOMIDE AND every 28 days

CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

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ClinicalTrials.gov Identifier: NCT00091260
Recruitment Status : Completed
First Posted : September 9, 2004
Results First Posted : February 20, 2017
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Vaishali Sanchorawala, Boston Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: dexamethasone
Drug: lenalidomide
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Revlimid
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lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

Period Title: Overall Study
Started 82
Completed 82
Not Completed 0
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lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

Overall Number of Baseline Participants 82
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
<=18 years
0
   0.0%
Between 18 and 65 years
58
  70.7%
>=65 years
24
  29.3%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
Female
29
  35.4%
Male
53
  64.6%
Dialysis y/n  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
on dialysis
7
   8.5%
Not on dialysis
75
  91.5%
1.Primary Outcome
Title Number of Patients Removed From Study Treatment Due to Toxicities
Hide Description [Not Specified]
Time Frame 1 year
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Number of patients who had at least one dose of CC-5013
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lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: participants
31
2.Primary Outcome
Title Number of Patients With Hematologic Response With Single-agent CC-5013
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Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.

Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.

For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.

For patients with an elevated serum free light chain assay, a reduction of 50% or more.

Time Frame 3 months
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Participants who received at least 3 cycles of single-agent CC-5013 and underwent subsequent evaluation.
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lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

dexamethasone: dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
5
  20.8%
3.Secondary Outcome
Title Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response
Hide Description [Not Specified]
Time Frame 1 year
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[Not Specified]
Arm/Group Title Revlimid
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lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
26
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
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lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

All-Cause Mortality
Revlimid
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Revlimid
Affected / at Risk (%) # Events
Total   82/82 (100.00%)    
Blood and lymphatic system disorders   
neutropenia * 1  15/82 (18.29%)  18
leukopenia * 2  5/82 (6.10%)  5
anemia * 2  2/82 (2.44%)  2
thrombocytopenia * 2  1/82 (1.22%)  1
Cardiac disorders   
hypotension * 2  3/82 (3.66%)  3
Myocardial infarction * 2  1/82 (1.22%)  1
organ rejection * 2 [1]  1/1 (100.00%)  1
cardiac, other * 2  5/82 (6.10%)  5
Gastrointestinal disorders   
diarrhea * 2  3/82 (3.66%)  3
nausea * 2  2/82 (2.44%)  2
pancreatitis * 2  1/82 (1.22%)  1
General disorders   
Fatigue * 2  18/82 (21.95%)  18
Decreased Performance Status * 2  15/82 (18.29%)  15
Nail Changes * 2  1/82 (1.22%)  1
dysphagia * 2  1/82 (1.22%)  1
dizziness * 2  6/82 (7.32%)  6
gout * 2  4/82 (4.88%)  6
Infections and infestations   
fever/infection * 2  4/82 (4.88%)  6
infection * 2 [2]  19/82 (23.17%)  19
increased INR * 2  2/82 (2.44%)  2
Investigations   
decreased phosphate * 2  13/82 (15.85%)  13
Musculoskeletal and connective tissue disorders   
muscle cramps * 2  1/82 (1.22%)  1
Renal and urinary disorders   
increased creatinine * 2  6/82 (7.32%)  8
Respiratory, thoracic and mediastinal disorders   
dyspnea * 2  3/82 (3.66%)  3
Skin and subcutaneous tissue disorders   
rash * 2  9/82 (10.98%)  10
Vascular disorders   
thrombosis * 2  6/82 (7.32%)  6
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, ctcae v3
2
Term from vocabulary, CTCAE (3.0)
[1]
rejection of previously transplanted heart
[2]
upper respiratory infection
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Revlimid
Affected / at Risk (%) # Events
Total   82/82 (100.00%)    
Blood and lymphatic system disorders   
neutropenia * 1  26/82 (31.71%)  32
leukopenia * 1  21/82 (25.61%)  26
anemia * 1  52/82 (63.41%)  53
thrombocytopenia * 1  27/82 (32.93%)  31
edema * 1  41/82 (50.00%)  41
Cardiac disorders   
hypotension * 1  7/82 (8.54%)  9
Chest pain * 1  7/82 (8.54%)  7
cardiac, other * 1  5/82 (6.10%)  5
Endocrine disorders   
cushingoid * 1  4/82 (4.88%)  4
Eye disorders   
visual disturbance * 1  11/82 (13.41%)  11
Gastrointestinal disorders   
Anorexia * 1  14/82 (17.07%)  14
early satiety * 1  18/82 (21.95%)  18
Change in appetite * 1  12/82 (14.63%)  12
constipation * 1  31/82 (37.80%)  33
diarrhea * 1  30/82 (36.59%)  34
dysphagia * 1  4/82 (4.88%)  4
hemorrhoids * 1  13/82 (15.85%)  13
dyspepsia * 1  17/82 (20.73%)  17
nausea * 1  24/82 (29.27%)  28
vomiting * 1  13/82 (15.85%)  15
GI other * 1  8/82 (9.76%)  8
hemorrhage - nose * 1  8/82 (9.76%)  8
General disorders   
fatigue * 1  54/82 (65.85%)  61
drowsiness * 1  11/82 (13.41%)  15
Decreased performance status * 1  30/82 (36.59%)  30
Insomnia * 1  39/82 (47.56%)  39
Weight change * 1  16/82 (19.51%)  19
Hot flashes * 1  4/82 (4.88%)  4
dry membranes * 1  13/82 (15.85%)  13
dizziness * 1  42/82 (51.22%)  45
tremors * 1  6/82 (7.32%)  6
headache * 1  12/82 (14.63%)  12
flu-like syndrome * 1  11/82 (13.41%)  11
Immune system disorders   
post nasal drip * 1  19/82 (23.17%)  19
Infections and infestations   
fever/infection * 1  21/82 (25.61%)  23
pulmonary infection * 1  26/82 (31.71%)  28
sinusitis * 1  10/82 (12.20%)  10
Investigations   
hyponatremia * 1  14/82 (17.07%)  17
hypokalemia * 1  15/82 (18.29%)  15
increased creatinine * 1  40/82 (48.78%)  40
hyperglycemia * 1  43/82 (52.44%)  45
hyperbilirubinemia * 1  7/82 (8.54%)  7
increased alkylase phosphate * 1  24/82 (29.27%)  31
increased alanine aminotransferase test * 1  17/82 (20.73%)  17
hypoalbuminemia * 1  33/82 (40.24%)  39
hypocalcemia * 1  31/82 (37.80%)  31
elevated blood urea nitrogen blood test * 1  11/82 (13.41%)  11
Musculoskeletal and connective tissue disorders   
muscle cramps * 1  53/82 (64.63%)  53
muscle weakness * 1  16/82 (19.51%)  16
pain - muscle * 1  9/82 (10.98%)  9
spasms * 1  8/82 (9.76%)  8
Nervous system disorders   
numbness - extremities * 1  11/82 (13.41%)  11
pain - extremities * 1  10/82 (12.20%)  10
tingling - extremities * 1  17/82 (20.73%)  17
Psychiatric disorders   
mood alteration * 1  10/82 (12.20%)  10
Renal and urinary disorders   
dysuria * 1  5/82 (6.10%)  5
Respiratory, thoracic and mediastinal disorders   
sore throat * 1  13/82 (15.85%)  13
cough * 1  25/82 (30.49%)  25
dyspnea * 1  28/82 (34.15%)  28
Skin and subcutaneous tissue disorders   
rash * 1  29/82 (35.37%)  30
itching * 1  22/82 (26.83%)  23
Derm/skin other * 1  7/82 (8.54%)  7
Easy bruising * 1  17/82 (20.73%)  17
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Vaishali Sanchorawala
Organization: Boston Medical Center
Phone: 6176386521
EMail: vaishali.sanchorawala@bmc.org
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Responsible Party: Vaishali Sanchorawala, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00091260     History of Changes
Other Study ID Numbers: CDR0000385687
BUMC-H-23235 ( Other Identifier: Boston University Medical Center IRB )
CELGENE-RV-AMYL-PI-003 ( Other Grant/Funding Number: Celgene )
First Submitted: September 7, 2004
First Posted: September 9, 2004
Results First Submitted: September 9, 2016
Results First Posted: February 20, 2017
Last Update Posted: February 20, 2017