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NCT02041325 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2016-05-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Positive for Hepatitis B Surface Antigen

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outcome · POSTED

Safety

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outcome · POSTED

Quantity of Subjects With a T-cell Response

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outcome · POSTED

Phenotypic Changes

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
    intervention Names
    1. Drug: Lenalidomide
    label
    Lenalidomide
    type
    EXPERIMENTAL
  2. description
    Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
    intervention Names
    1. Drug: Placebo
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Lenalidomide
    description
    Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
    name
    Lenalidomide
    other Names
    1. CC-5013
    2. Revlimid
    type
    DRUG
  2. arm Group Labels
    1. Placebo
    description
    Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
    name
    Placebo
    other Names
    1. Sugar pill
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
Enrollment
count
38
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).
    measure
    Positive for Hepatitis B Surface Antigen
    time Frame
    6 weeks
secondary Outcomes
  1. description
    Number of participants with adverse events as a measure of safety and tolerability
    measure
    Safety
    time Frame
    6 weeks
  2. description
    Participants who displayed a T cell responses against HbSAg following vaccination
    measure
    Quantity of Subjects With a T-cell Response
    time Frame
    6 weeks
  3. description
    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.
    measure
    Phenotypic Changes
    time Frame
    6 weeks
Full study description
brief 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.
detailed Description
The primary object of this study is to evaluate the effect of CC-5013 on the response to hepatitis B vaccine in myeloma. Secondary objectives include the evaluation of immunologic and functional genomic changes following CC-55013. This study will be a two-center, randomized, double-blinded, placebo-controlled trial. A single dose of Hepatitis B vaccine will be administered to subjects. CC-5013 or placebo will be administered for 7 days prior to and 7 days after the vaccine. Collection of samples for immune analysis will be performed prior to the initiation of CC-5013 administration, at the time of vaccination, and 7, 14, and 28 days after vaccination. Safety assessment will be performed at each visit. Primary Endpoint * Titer of antibodies to hepatitis B virus Secondary Endpoints * Immune analysis * Hepatitis B related T cell response * Safety profile All the patients should not have a prior response against hepatitis B surface antigen. The study will be comprised of 64 multiple myeloma patients who have not taken any therapeutic agents in the 30 days prior to enrollment in the study. Subjects will be randomly assigned to receive or not receive CC-5013, and all will be vaccinated. The study is designed to detect a biological difference of 50% with an alpha of 0.05 and a beta of 0.8.
Source references
Source notices and limitations
    Discovery and provenance
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      id
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      occurrences
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        exact text
        NCT02041325
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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    Preserved source evidence · Not medical advice