Trial Outcomes & Findings for Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias (NCT NCT02041325)

NCT ID: NCT02041325

Last Updated: 2016-05-17

Results Overview

The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2016-05-17

Participant Flow

Participant milestones

Measure	Lenalidomide Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd 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 Study STARTED	22	16
Overall Study COMPLETED	19	13
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lenalidomide n=22 Participants Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.	Placebo n=16 Participants Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.	Total n=38 Participants Total of all reporting groups
Age, Continuous	77 years n=5 Participants	67.5 years n=7 Participants	72.3 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).

Outcome measures

Measure	Lenalidomide n=22 Participants 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 n=16 Participants 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.
Positive for Hepatitis B Surface Antigen	4 participants	3 participants

SECONDARY outcome

Timeframe: 6 weeks

Number of participants with adverse events as a measure of safety and tolerability

Outcome measures

Measure	Lenalidomide n=22 Participants 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 n=16 Participants 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.
Safety	2 participants	2 participants

SECONDARY outcome

Timeframe: 6 weeks

Participants who displayed a T cell responses against HbSAg following vaccination

Outcome measures

Measure	Lenalidomide n=22 Participants 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 n=16 Participants 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.
Quantity of Subjects With a T-cell Response	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 weeks

Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.

Outcome measures

Measure	Lenalidomide n=22 Participants 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 n=16 Participants 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.
Phenotypic Changes Total T cells CD3+	851.5 cells/cmm Interval 630.0 to 1570.0	715 cells/cmm Interval 531.0 to 1834.0
Phenotypic Changes Helper T cells CD3+/CD4+	591 cells/cmm Interval 388.0 to 1094.0	525 cells/cmm Interval 316.0 to 1055.0
Phenotypic Changes Cytotoxic T cells CD3+/CD8+	296 cells/cmm Interval 77.0 to 528.0	183 cells/cmm Interval 117.0 to 1243.0
Phenotypic Changes Natural Killer cells CD56+/CD16+	249.5 cells/cmm Interval 98.0 to 662.0	228 cells/cmm Interval 180.0 to 418.0

Adverse Events

Lenalidomide

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lenalidomide n=22 participants at risk Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.	Placebo n=16 participants at risk Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
Cardiac disorders Myocardial Infartion	0.00% 0/22	6.2% 1/16 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/22	6.2% 1/16 • Number of events 1
Injury, poisoning and procedural complications Bleeding	4.5% 1/22 • Number of events 1	0.00% 0/16
Gastrointestinal disorders Ischemic Colitis	4.5% 1/22 • Number of events 1	0.00% 0/16

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nikhil C. Munshi

BVARI

Phone: 857-203-6172

Email: nikhil_munshi@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place