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Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias

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ClinicalTrials.gov Identifier: NCT02041325
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : May 17, 2016
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Nikhil Munshi, M.D., Boston VA Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Plasma Cell Disorder
Interventions Drug: Lenalidomide
Drug: Placebo
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine. Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
Period Title: Overall Study
Started 22 16
Completed 19 13
Not Completed 3 3
Arm/Group Title Lenalidomide Placebo Total
Hide Arm/Group Description Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine. Subjects will receive placebo for 7 days prior to and 7 days after the vaccine. Total of all reporting groups
Overall Number of Baseline Participants 22 16 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 16 participants 38 participants
77
(46 to 90)
67.5
(47 to 78)
72.3
(46 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 16 participants 38 participants
Female
5
  22.7%
6
  37.5%
11
  28.9%
Male
17
  77.3%
10
  62.5%
27
  71.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 16 participants 38 participants
22 16 38
1.Primary Outcome
Title Positive for Hepatitis B Surface Antigen
Hide Description The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.

Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.

Placebo will be administered for 7 days prior to and 7 days after the vaccine.

Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine.

Overall Number of Participants Analyzed 22 16
Measure Type: Number
Unit of Measure: participants
4 3
2.Secondary Outcome
Title Safety
Hide Description Number of participants with adverse events as a measure of safety and tolerability
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
Overall Number of Participants Analyzed 22 16
Measure Type: Number
Unit of Measure: participants
2 2
3.Secondary Outcome
Title Quantity of Subjects With a T-cell Response
Hide Description Participants who displayed a T cell responses against HbSAg following vaccination
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Placebo: Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Overall Number of Participants Analyzed 22 16
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Phenotypic Changes
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
Overall Number of Participants Analyzed 22 16
Median (Full Range)
Unit of Measure: cells/cmm
Total T cells CD3+
851.5
(630 to 1570)
715
(531 to 1834)
Helper T cells CD3+/CD4+
591
(388 to 1094)
525
(316 to 1055)
Cytotoxic T cells CD3+/CD8+
296
(77 to 528)
183
(117 to 1243)
Natural Killer cells CD56+/CD16+
249.5
(98 to 662)
228
(180 to 418)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine. Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
All-Cause Mortality
Lenalidomide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      2/16 (12.50%)    
Cardiac disorders     
Myocardial Infartion *  0/22 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders     
Ischemic Colitis *  1/22 (4.55%)  1 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Bleeding *  1/22 (4.55%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal Pain *  0/22 (0.00%)  0 1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/16 (0.00%)    
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
Name/Title: Dr. Nikhil C. Munshi
Organization: BVARI
Phone: 857-203-6172
Responsible Party: Nikhil Munshi, M.D., Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02041325     History of Changes
Other Study ID Numbers: IRB 1831
First Submitted: January 14, 2014
First Posted: January 22, 2014
Results First Submitted: February 9, 2016
Results First Posted: May 17, 2016
Last Update Posted: May 17, 2016