Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 100 of 491 for:    LENALIDOMIDE AND every 28 days

Lenalidomide for Patients With Myelofibrosis (MF)

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: NCT00352794
Recruitment Status : Completed
First Posted : July 17, 2006
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myelofibrosis
Interventions Drug: Lenalidomide
Drug: Prednisone
Enrollment 40
Recruitment Details Recruitment Period: July 2006 - April 2007
Pre-assignment Details  
Arm/Group Title Lenalidomide + Prednisone
Hide Arm/Group Description

Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle

Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title Lenalidomide + Prednisone
Hide Arm/Group Description

Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle

Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  55.0%
>=65 years
18
  45.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
62
(41 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
17
  42.5%
Male
23
  57.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
38
  95.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
 100.0%
1.Primary Outcome
Title Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)
Hide Description Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide + Prednisone
Hide Arm/Group Description:

Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle

Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
14
  35.0%
Time Frame For at least 6 cycles, and up to 11 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide + Prednisone
Hide Arm/Group Description

Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

Lenalidomide: Oral 10 mg daily/days 1-21 of 28 day cycle

Prednisone: Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.

All-Cause Mortality
Lenalidomide + Prednisone
Affected / at Risk (%)
Total   3/40 (7.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide + Prednisone
Affected / at Risk (%) # Events
Total   7/40 (17.50%)    
Blood and lymphatic system disorders   
Increased Transaminase  1  1/40 (2.50%)  1
Gastrointestinal disorders   
Cholecystitis  1  1/40 (2.50%)  1
General disorders   
Abdominal Pain  1  1/40 (2.50%)  1
Back Pain  1  1/40 (2.50%)  3
Death  1  3/40 (7.50%)  3
Fatigue  1  1/40 (2.50%)  1
West Nile Virus  1  1/40 (2.50%)  1
Infections and infestations   
Infection  1  3/40 (7.50%)  3
Metabolism and nutrition disorders   
Hyperbilirubinemia  1  1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/40 (2.50%)  3
Surgical and medical procedures   
Mitral Heart Valve Repair  1  1/40 (2.50%)  1
Stent Replacement  1  1/40 (2.50%)  1
1
Term from vocabulary, CTCAE (3.0)
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 5%
Lenalidomide + Prednisone
Affected / at Risk (%) # Events
Total   40/40 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  21/40 (52.50%)  33
Anemia  1  15/40 (37.50%)  17
Thrombocytopenia  1  9/40 (22.50%)  11
Thrombocytosis  1  3/40 (7.50%)  3
Hyperbilirubinemia  1  4/40 (10.00%)  4
Edema  1  8/40 (20.00%)  8
Decreased White Blood Count  1  22/40 (55.00%)  35
Gastrointestinal disorders   
Diarrhea  1  12/40 (30.00%)  14
Constipation  1  2/40 (5.00%)  2
Heartburn  1  2/40 (5.00%)  2
Hemorrhoids  1  2/40 (5.00%)  2
Vomiting  1  2/40 (5.00%)  2
Nausea  1  4/40 (10.00%)  4
General disorders   
fatigue  1  14/40 (35.00%)  14
Sweating  1  3/40 (7.50%)  3
Headache  1  4/40 (10.00%)  4
Pain  1  21/40 (52.50%)  27
Hepatobiliary disorders   
Increased Transaminase  1  2/40 (5.00%)  3
Infections and infestations   
Infection  1  17/40 (42.50%)  24
Metabolism and nutrition disorders   
Hypokalemia  1  2/40 (5.00%)  2
Nervous system disorders   
Depression  1  2/40 (5.00%)  2
Dizziness  1  3/40 (7.50%)  3
Neuropathy  1  4/40 (10.00%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/40 (5.00%)  2
Dyspnea  1  4/40 (10.00%)  4
Skin and subcutaneous tissue disorders   
Rash  1  6/40 (15.00%)  6
Pruritis  1  2/40 (5.00%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Srdan Verstovsek, MD., Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-745-3429
EMail: sverstov@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00352794     History of Changes
Other Study ID Numbers: 2005-0206
First Submitted: July 14, 2006
First Posted: July 17, 2006
Results First Submitted: April 23, 2019
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019