Investigation of the Enhancement of the Response to Hepatitis B Vaccine by Lenalidomide (RevlimidTM, CC-5013) in Plasma Cell Dyscrasias
This is a research study to determine if the study drug lenalidomide will increase the body's immune response, which is the body's response against infections or tumors, to hepatitis B vaccine in patients with plasma cell diseases which include multiple myeloma, monoclonal gammopathy of unknown significance (MGUS) and Waldenström's Macroglobulinemia. It is not a study to see if lenalidomide is an effective treatment for plasma cell disease.
Participants in this study have multiple myeloma or other plasma cell disease and have never been vaccinated with hepatitis B vaccine. One of the effects of the drug lenalidomide is to alter the immune system and thereby increase immune response. It also has some effect against cancer cells; therefore, in theory, it may reduce or prevent the growth of cancer cells.
In this study, one-half of the subjects will be chosen at random to receive the study drug and the other half will take a placebo pill (a sugar pill that looks the same as the real medication). This is a double blind study where neither the subjects nor the investigators know whether the patient receives the study drugs or placebo pills. The effects of the active drug lenalidomide will be compared to the effects of the placebo. The results from this study will be also be compared with a similar but separate study to be done on individuals without known disease.
This study expects to enroll 64 subjects and will be carried out at the Boston VA Healthcare System and the Dana Farber Cancer Institute.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Investigation of the Enhancement of the Response to Hepatitis B Vaccine by Lenalidomide (RevlimidTM, CC-5013) in Plasma Cell Dyscrasias|
- Hepatitis B surface antigen [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Antibody titer against hepatitis B surface antigen (HbSAg).
- Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Number of participants with adverse events as a measure of safety and tolerability
- T-cell response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]T cell responses against HbSAg following vaccination
- Phenotypic changes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Gene Expression Profile of Immune cells [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Changes in gene expression profile of immune cells before and after the treatment of CC-5013 (lenalidomide) using micro array protocols.
|Study Start Date:||April 2005|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.
Placebo Comparator: Placebo
Placebo will be administered for 7 days prior to and 7 days after the vaccine.
Other Name: Sugar pill
Please refer to this study by its ClinicalTrials.gov identifier: NCT02041325
|United States, Massachusetts|
|VA Boston Healthcare System|
|Boston, Massachusetts, United States, 02130|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Nikhil C Munshi, M.D.||VA Boston Healthcare System; Harvard Medical School; Dana-Farber Cancer Institute|