Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias
Condition: Plasma Cell Disorder
MeSH terms: Hepatitis B; Multiple Myeloma; Neoplasms, Plasma Cell; Paraproteinemias
Intervention: Lenalidomide; Placebo
Intervention 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.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form.

          -  Age > = 18 years at the time of signing the informed consent form.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  Must have confirmed diagnosis of plasma cell disorder.

          -  Patients with prior thalidomide or CC-5013 (lenalidomide) use are eligible but these
             agents must have been discontinued at least 4 weeks prior to treatment in this study.

          -  All previous cancer therapy, including chemotherapy, and dexamethsone must have been
             discontinued at least 4 weeks prior to treatment in this study. Patients with recent
             radiation, hormonal therapy and surgery are eligible.

          -  Patients must not have received prior Hepatitis B vaccination.

          -  Patient should be negative for antibody against HbSAg.

          -  ANC >= 1000, Platelets >= 75,000.

          -  Women of childbearing potential (WCBP) must have a negative urine pregnancy test at
             screening (Visit 1). In addition, sexually active WCBP must agree to use two of the
             following adequate forms of contraception throughout the entire study (tubal ligation;
             intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
             A WCBP must agree to have pregnancy tests 4 weeks after her last dose of lenalidomide.
             Due to the short duration of drug therapy, abstinence would also be a reasonable
             option.

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          -  Pregnant or lactating females.

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          -  Use of any other experimental drug or therapy within 28 days of baseline.

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Concurrent use of other anti-cancer agents or treatments.

          -  Known HIV, HBV and HCV positivity.

          -  Clinically significant autoimmune disease.

          -  Serious intercurrent illness such as active infection requiring IV antibiotics,
             significant cardiac or pulmonary disease.

          -  Psychiatric disorder, alcohol or illicit drug use.