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Trial record 59 of 881 for:    LENALIDOMIDE

A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients

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: NCT00699842
Recruitment Status : Terminated (Administratively terminated per FDA recommendation)
First Posted : June 18, 2008
Results First Posted : June 3, 2014
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic Syndrome
MDS
Low to Intermediate-1 MDS
Non-deletion 5q
Intervention Drug: Lenalidomide
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg)
Hide Arm/Group Description

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days
Period Title: Overall Study
Started 3 5 0
Completed 3 4 0
Not Completed 0 1 0
Reason Not Completed
Death             0             1             0
Arm/Group Title Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg) Total
Hide Arm/Group Description

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days
Total of all reporting groups
Overall Number of Baseline Participants 3 5 0 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 0 participants 8 participants
57.38  (20.06) 65.98  (11.02) 62.76  (14.29)
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 0 participants 8 participants
<=18 years 0 0 0
Between 18 and 65 years 2 3 5
>=65 years 1 2 3
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 0 participants 8 participants
Female 0 2 2
Male 3 3 6
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 0 participants 8 participants
American Indian or Alaska Native 0 0 0
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 3 4 7
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 0 participants 8 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 1 2 3
Unknown or Not Reported 2 3 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 5 participants 0 participants 8 participants
3 5 8
1.Primary Outcome
Title Determine CR, PR, and Rate of Stable Disease in MDS Patients
Hide Description Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in >10mg doses of lenalidomide
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg)
Hide Arm/Group Description:

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Safety With Dose Escalation
Hide Description Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg)
Hide Arm/Group Description:

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg)
Hide Arm/Group Description

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days

Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.

Lenalidomide: Dose Level Lenalidomide Schedule

  1. 15mg/day for d1-21 out of 28 days
  2. 20mg/day for d1-21 out of 28 days
  3. 25mg/day for d1-21 out of 28 days
All-Cause Mortality
Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/5 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide (15mg) Lenalidomide (20mg) Lenalidomide (25mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      5/5 (100.00%)      0/0    
Blood and lymphatic system disorders       
Elevated blood pressure  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Anemia  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Neutropenia  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Decreased hemoglobin  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Thrombocytopenia  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Hypoglycemia  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Cardiac disorders       
Palpitations  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Eye disorders       
Dry eyes  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Change in vision  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Itching of eyes  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Light flashes in right eye  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Gastrointestinal disorders       
Diarrhea  2/3 (66.67%)  2 4/5 (80.00%)  4 0/0  0
Constipation  1/3 (33.33%)  1 1/5 (20.00%)  1 0/0  0
Hemorrhoids  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Upset stomach  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
General disorders       
Fatigue  3/3 (100.00%)  4 4/5 (80.00%)  4 0/0  0
Hoarseness  2/3 (66.67%)  2 0/5 (0.00%)  0 0/0  0
Swelling in legs  1/3 (33.33%)  2 0/5 (0.00%)  0 0/0  0
Weakness  2/3 (66.67%)  2 1/5 (20.00%)  1 0/0  0
Insomnia  2/3 (66.67%)  2 2/5 (40.00%)  2 0/0  0
Post nasal drip  1/3 (33.33%)  1 1/5 (20.00%)  1 0/0  0
Sore throat  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Cough with sputum production  2/3 (66.67%)  2 1/5 (20.00%)  1 0/0  0
Problems with balance/dizziness  1/3 (33.33%)  2 1/5 (20.00%)  2 0/0  0
Swollen glands/lumps  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Lack of energy/lack of motivation  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Fever  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Itching  2/3 (66.67%)  2 4/5 (80.00%)  4 0/0  0
Achiness under armpit  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Back pain  1/3 (33.33%)  1 1/5 (20.00%)  1 0/0  0
Pain in arm at injection site  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Headache  1/3 (33.33%)  1 2/5 (40.00%)  2 0/0  0
Cough  1/3 (33.33%)  2 1/5 (20.00%)  1 0/0  0
Sweats  1/3 (33.33%)  1 2/5 (40.00%)  2 0/0  0
Sinus pain/congestion  1/3 (33.33%)  1 2/5 (40.00%)  2 0/0  0
Nausea  1/3 (33.33%)  1 1/5 (20.00%)  1 0/0  0
Vomiting  1/3 (33.33%)  1 1/5 (20.00%)  1 0/0  0
Change in appetite  0/3 (0.00%)  0 2/5 (40.00%)  2 0/0  0
Weight loss  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Dry mouth/sores  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Shakiness  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Alopecia  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Hip pain  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Tired  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Dark urine  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Swollen foot  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Lightheadedness  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Chills  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Dehydration  0/3 (0.00%)  0 2/5 (40.00%)  2 0/0  0
Pain in right hemithorax  0/3 (0.00%)  0 2/5 (40.00%)  2 0/0  0
Shoulder pain  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Infection  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Swollen abdomen  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Achiness  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Tooth abscess  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Bone pain  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Musculoskeletal and connective tissue disorders       
Muscle ache/pain  3/3 (100.00%)  3 1/5 (20.00%)  1 0/0  0
Joint pain/stiffness  1/3 (33.33%)  1 2/5 (40.00%)  3 0/0  0
Muscle spasms  2/3 (66.67%)  2 0/5 (0.00%)  0 0/0  0
Cramping  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Nervous system disorders       
Numbness/tingling  3/3 (100.00%)  4 3/5 (60.00%)  3 0/0  0
Psychiatric disorders       
Anxiety  2/3 (66.67%)  3 1/5 (20.00%)  1 0/0  0
Memory changes  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Renal and urinary disorders       
Awakening to urinate  3/3 (100.00%)  4 3/5 (60.00%)  3 0/0  0
Urinary frequency  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Burning after urination  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Urinary tract infection  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Respiratory, thoracic and mediastinal disorders       
Shortness of breath  2/3 (66.67%)  5 2/5 (40.00%)  3 0/0  0
Painful breathing  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Sleep apnea  1/3 (33.33%)  1 0/5 (0.00%)  0 0/0  0
Scattered rales  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Skin and subcutaneous tissue disorders       
Rash  1/3 (33.33%)  1 1/5 (20.00%)  1 0/0  0
Pale skin  1/3 (33.33%)  3 0/5 (0.00%)  0 0/0  0
Lesions  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Red spots on leg  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Raised bumps on neck  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Dry skin  0/3 (0.00%)  0 2/5 (40.00%)  2 0/0  0
Pimple/boil  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Bruising  0/3 (0.00%)  0 1/5 (20.00%)  1 0/0  0
Study was terminated as the objectives of this study have already been addressed in a larger study, and therefore the study is unlikely to yield any new information. The study closed before any data for the outcome measures was able to be collected.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Emmanuel Besa, MD
Organization: Thomas Jefferson University
Phone: 215-955-8874
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT00699842     History of Changes
Other Study ID Numbers: 07C.446
RV-MDS-PI-244 ( Other Identifier: Celgene )
2007-31 ( Other Identifier: CCRRC )
First Submitted: June 13, 2008
First Posted: June 18, 2008
Results First Submitted: February 27, 2014
Results First Posted: June 3, 2014
Last Update Posted: November 29, 2016