Plasma Cell Disorder Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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