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Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS

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ClinicalTrials.gov Identifier: NCT01133275
Recruitment Status : Active, not recruiting
First Posted : May 28, 2010
Results First Posted : January 18, 2016
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic Syndrome
MDS
Interventions Drug: Prednisone
Drug: Lenalidomide
Enrollment 28
Recruitment Details Participants were recruited at Moffitt Cancer Center and Shands Cancer Hospital at the University of Florida from 4/28/2010 through 8/13/2013.
Pre-assignment Details  
Arm/Group Title Lenalidomide and Prednisone Therapy
Hide Arm/Group Description Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
Period Title: Overall Study
Started 28
Completed 26
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Cerebrovascular accident (CVA)             1
Arm/Group Title Lenalidomide and Prednisone Therapy
Hide Arm/Group Description Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
All participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  28.6%
>=65 years
20
  71.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants
68.64
(22 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
10
  35.7%
Male
18
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Number of Participants With Erythroid Response
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants
Arm/Group Title Lenalidomide and Prednisone Therapy
Hide Arm/Group Description:
Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
5
2.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment
Hide Description Grade 3 or 4 events Related/Possibly Related/Probably Related to study treatment. Number of participants with events specified in the study protocol: Neutropenia, Thrombocytopenia, Febrile Neutropenia, Infection, Sepsis, Venous Thromboembolic Events. Evaluations according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.0.
Time Frame Up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Lenalidomide and Prednisone Therapy
Hide Arm/Group Description:
Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
Neutropenia 8
Thrombocytopenia 4
Febrile Neutropenia 0
Infection and Sepsis 0
Venous Thromboembolic Events 0
Time Frame 4 years, 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide and Prednisone Therapy
Hide Arm/Group Description Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
All-Cause Mortality
Lenalidomide and Prednisone Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide and Prednisone Therapy
Affected / at Risk (%) # Events
Total   8/28 (28.57%)    
Blood and lymphatic system disorders   
Anemia  1  1/28 (3.57%)  1
Blood clot  1  1/28 (3.57%)  1
Cardiac disorders   
Myocardial infarction  1  1/28 (3.57%)  1
Chest pain  1  1/28 (3.57%)  1
Heart arrhythmia  1  1/28 (3.57%)  1
Gastrointestinal disorders   
Diarrhea  1  1/28 (3.57%)  1
Rectal bleeding  1  1/28 (3.57%)  1
Severe abdominal cramping  1  1/28 (3.57%)  1
Severe nausea  1  1/28 (3.57%)  1
Uncontrolled vomiting  1  1/28 (3.57%)  1
Small intestinal blockage  1  1/28 (3.57%)  1
General disorders   
Edema limbs  1  1/28 (3.57%)  1
Sudden death NOS  1  1/28 (3.57%)  1
Fever  1  1/28 (3.57%)  1
Pain - sore throat  1  1/28 (3.57%)  1
Infections and infestations   
Soft tissue infection  1  1/28 (3.57%)  1
Metabolism and nutrition disorders   
Hyponatremia  1  1/28 (3.57%)  1
Nervous system disorders   
Stroke / Cerebrovascular Accident (CVA)  1  1/28 (3.57%)  1
Psychiatric disorders   
Confusion  1  1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/28 (3.57%)  1
Pulmonary hypertension  1  1/28 (3.57%)  1
Pneumonitis  1  1/28 (3.57%)  1
Pneumonia  1  1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide and Prednisone Therapy
Affected / at Risk (%) # Events
Total   27/28 (96.43%)    
Blood and lymphatic system disorders   
Anemia  1  15/28 (53.57%)  36
Leukocytosis  1  5/28 (17.86%)  5
Eye disorders   
Blurred vision  1  4/28 (14.29%)  4
Eye disorders - Other  1  2/28 (7.14%)  2
Gastrointestinal disorders   
Diarrhea  1  13/28 (46.43%)  18
Constipation  1  6/28 (21.43%)  7
Nausea  1  5/28 (17.86%)  7
Vomiting  1  5/28 (17.86%)  5
Abdominal pain  1  3/28 (10.71%)  3
Gastrointestinal disorders - Other  1  3/28 (10.71%)  3
Dry mouth  1  2/28 (7.14%)  3
Dysphagia  1  2/28 (7.14%)  2
Mucositis oral  1  2/28 (7.14%)  2
General disorders   
Fatigue  1  13/28 (46.43%)  14
Edema limbs  1  7/28 (25.00%)  10
Paul  1  7/28 (25.00%)  9
Fever  1  5/28 (17.86%)  5
Chills  1  4/28 (14.29%)  4
Infections and infestations   
Sinusitis  1  2/28 (7.14%)  2
Injury, poisoning and procedural complications   
Bruising  1  6/28 (21.43%)  6
Fall  1  4/28 (14.29%)  4
Investigations   
Platelet count decreased  1  16/28 (57.14%)  37
Neutrophil count decreased  1  13/28 (46.43%)  49
White blood cell decreased  1  13/28 (46.43%)  40
Creatinine increased  1  2/28 (7.14%)  2
Investigations - Other  1  2/28 (7.14%)  4
Lymphocyte count decreased  1  2/28 (7.14%)  5
Weight gain  1  2/28 (7.14%)  3
Metabolism and nutrition disorders   
Hyperglycemia  1  4/28 (14.29%)  4
Hypokalemia  1  3/28 (10.71%)  4
Metabolism and nutrition disorders - Other  1  2/28 (7.14%)  6
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  4/28 (14.29%)  4
Musculoskeletal and connective tissue disorder - Other  1  4/28 (14.29%)  5
Nervous system disorders   
Movements involuntary  1  6/28 (21.43%)  6
Dizziness  1  4/28 (14.29%)  5
Headache  1  4/28 (14.29%)  4
Memory impairment  1  2/28 (7.14%)  2
Peripheral sensory neuropathy  1  2/28 (7.14%)  3
Sinus pain  1  2/28 (7.14%)  3
Psychiatric disorders   
Insomnia  1  6/28 (21.43%)  6
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  6/28 (21.43%)  7
Cough  1  3/28 (10.71%)  3
Hoarseness  1  3/28 (10.71%)  3
Nasal congestion  1  3/28 (10.71%)  3
Allergic rhinitis  1  2/28 (7.14%)  2
Productive cough  1  2/28 (7.14%)  2
Respiratory, thoracic and mediastinal disorders - Other  1  2/28 (7.14%)  2
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  5/28 (17.86%)  5
Pruritus  1  5/28 (17.86%)  7
Rash maculo-papular  1  3/28 (10.71%)  3
Skin and subcutaneous tissue disorders - Other  1  3/28 (10.71%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The study was terminated at the end of step one, as no signal of higher response of the combination was observed compared to what was reported on the MDS-002 study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Rami Komrokji
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-4692
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01133275     History of Changes
Other Study ID Numbers: MCC-16099
RV-MDS-PI-0456 ( Other Identifier: Celgene Corp. )
25005/1 ( Other Identifier: Quorum Review IRB )
First Submitted: May 25, 2010
First Posted: May 28, 2010
Results First Submitted: December 14, 2015
Results First Posted: January 18, 2016
Last Update Posted: April 3, 2019