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Trial record 16 of 495 for:    LENALIDOMIDE AND every 28 days

Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov Identifier: NCT01222195
Recruitment Status : Terminated (Low accrual.)
First Posted : October 18, 2010
Results First Posted : April 26, 2011
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: Lenalidomide
Drug: Darbepoetin alfa
Enrollment 1
Recruitment Details Recruitment Period: 2/22/2009 to 4/20/2010. All patients were registered at The University of Texas M.D. Anderson Cancer Center.
Pre-assignment Details Study terminated due to low accrual, one patient registered on study.
Arm/Group Title Lenalidomide + Darbepoetin Alfa
Hide Arm/Group Description Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Lenalidomide + Darbepoetin Alfa
Hide Arm/Group Description Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Patients With a Transfusion Independence Response
Hide Description Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.
Time Frame Over six 28-day cycles (approximately 168 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol.
Arm/Group Title Lenalidomide + Darbepoetin Alfa
Hide Arm/Group Description:
Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
0
Time Frame 1 year 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide + Darbepoetin Alfa
Hide Arm/Group Description Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
All-Cause Mortality
Lenalidomide + Darbepoetin Alfa
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide + Darbepoetin Alfa
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Infections and infestations   
Neutropenic fever  1  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide + Darbepoetin Alfa
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Cardiac disorders   
Bilateral edema  1  1/1 (100.00%)  1
General disorders   
fatigue  1  1/1 (100.00%)  1
Bone Pain  1  1/1 (100.00%)  1
Indicates events were collected by 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: Gautam Borthakur, MBBS / Assistant Professor
Organization: The University of Texas M. D. Anderson Cancer Center
Phone: 713-792-7305
EMail: eharriso@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01222195     History of Changes
Other Study ID Numbers: 2006-0657
First Submitted: October 14, 2010
First Posted: October 18, 2010
Results First Submitted: March 30, 2011
Results First Posted: April 26, 2011
Last Update Posted: August 7, 2012