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Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)

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ClinicalTrials.gov Identifier: NCT01927718
Recruitment Status : Terminated (Poor Response Rate)
First Posted : August 23, 2013
Results First Posted : April 29, 2019
Last Update Posted : April 29, 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 Myeloma
Interventions Drug: Thalidomide
Drug: Lenalidomide
Behavioral: Questionnaires
Enrollment 10
Recruitment Details Recruitment Period: January 2014 to august 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Thalidomide + Lenalidomide
Hide Arm/Group Description Thalidomide 100 mg by mouth daily for 28 days; Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Thalidomide + Lenalidomide
Hide Arm/Group Description Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
62
(37 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
9
  90.0%
Unknown or Not Reported
1
  10.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  40.0%
White
5
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Number of Participants With Response
Hide Description Primary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to < 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thalidomide + Lenalidomide
Hide Arm/Group Description:
Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
Time Frame Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thalidomide + Lenalidomide
Hide Arm/Group Description Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.
All-Cause Mortality
Thalidomide + Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Thalidomide + Lenalidomide
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Thalidomide + Lenalidomide
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/10 (10.00%)  1
Neutropenia  1  4/10 (40.00%)  4
Gastrointestinal disorders   
Constipation  1  2/10 (20.00%)  2
Diarrhea  1  2/10 (20.00%)  2
Nausea  1  1/10 (10.00%)  1
Investigations   
Elevated alanine transaminase (ALT)  1  1/10 (10.00%)  1
Elevated Aspartate aminotransferase (AST)  1  1/10 (10.00%)  1
Elevated creatinine  1  4/10 (40.00%)  4
Infection  1  2/10 (20.00%)  2
Loss of balance  1  1/10 (10.00%)  1
Low white blood count  1  2/10 (20.00%)  2
Metabolism and nutrition disorders   
Hyperglycemia  1  1/10 (10.00%)  1
Hypoalbuminemia  1  1/10 (10.00%)  1
Hypocalcemia  1  1/10 (10.00%)  1
Hypokalemia  1  1/10 (10.00%)  1
Hypomagnesemia  1  2/10 (20.00%)  2
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/10 (10.00%)  1
Muscle cramping  1  1/10 (10.00%)  1
Nervous system disorders   
Dizziness  1  1/10 (10.00%)  1
Headache  1  1/10 (10.00%)  1
Lethargy  1  2/10 (20.00%)  2
Nerve pain  1  1/10 (10.00%)  1
paraesthesia  1  1/10 (10.00%)  1
Peripheral neuropathy  1  4/10 (40.00%)  4
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/10 (10.00%)  1
Shortness of breath  1  1/10 (10.00%)  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: Qaiser Bashir, MD/Associate Professor, Stem Cell Transplantation
Organization: UT MD Anderson Cancer Center
Phone: 713-792-7734
EMail: QBashir@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01927718     History of Changes
Other Study ID Numbers: 2011-0806
NCI-2014-00157 ( Registry Identifier: NCI CTRP )
First Submitted: August 20, 2013
First Posted: August 23, 2013
Results First Submitted: November 22, 2017
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019