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B-Cell Hematologic Malignancy Vaccination Registry (HMvax-Regist)

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ClinicalTrials.gov Identifier: NCT02298816
Recruitment Status : Enrolling by invitation
First Posted : November 24, 2014
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Vince Lombardi Cancer Clinic
Information provided by (Responsible Party):
Michael A. Thompson, MD, PhD, Aurora Health Care

Brief Summary:
The goal of this study is to develop a vaccination registry system for Aurora Health Care patients newly diagnosed with MM and other B-Cell Hematologic Malignancies in order to prospectively characterize vaccination history and outcomes such as infection in these patients at Aurora Health Care. Additionally hospitalization rates, cost analysis, infection (influenza, pneumonia, other) related to vaccination in this patient population will be evaluated.

Condition or disease
Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Waldenstrom Macroglobulinemia Lymphocytosis Lymphoma, Non-Hodgkin B-Cell Chronic Lymphocytic Leukemia Hematological Malignancies

Detailed Description:

This is a prospective registry study on the immunizations in patients with B-Cell Hematologic Malignancies at Aurora Health Care. This observational study will consist of prospective medical record review of Aurora Health Care patients newly diagnosed B-Cell Hematologic Malignancies and will be used to characterize vaccination history, infection rate, and hospitalization rate. This is the second study in the series of studies designed to provide important information about the best way and time to vaccinate patients with MM and similar cancers to flu and pneumonia and to gather additional information about immune function in this patient population.

The registry will include all adult patients who are newly diagnosed with the following B-Cell Hematologic Malignancies: Monoclonal gammopathy of undetermined significance (MGUS), Smoldering multiple myeloma (SMM), Multiple myeloma (MM), Waldenstroms Macroglobulinemia (WM), Monoclonal B-cell lymphocytosis (MBL), Chronic lymphocytic leukemia (CLL), or B-Cell Non-Hodgkin lymphoma (NHL). The prevalence of newly diagnosed B-Cell Hematologic Malignancies at Aurora Health Care is approximately 1000 patients annually. This registry will be ongoing to collect real time data, with no definite sample size planned; however, data will be collected for at least 10 years. This time frame is based on Surveillance, Epidemiology, and End Results Program (SEER) data. There is a 50% survival rate at 5 years after diagnosis for MM, so the 10 year time frame will be able to capture long term outcome in patients.

Medical record information will be obtained through electronic data capture by Aurora Health Care staff with access to the electronic medical records. Data will be manually reviewed by the coordinator, Investigator and co-investigators for accuracy and completeness, to the extent available in the clinical medical record. Additionally, a biostatistician will assist in data analysis.

Descriptive statistics such as counts, proportions or percentages for category variables and mean and standard deviation for continuous variables will be computed for the all the variables. Depending upon the distribution of the category variables appropriate statistical tests such as chi-square and/or Fisher exact test will be used to find out the statistical significance. For continuous variables an appropriate statistical test such as t-tests and/or F test will be used.

This registry will be used for this research study, and may be queried for internal quality improvement projects as well. The principal investigator will be responsible for the overall monitoring of the data and safety of study participants/data integrity, with the assistance of other study team members.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: B-Cell Hematologic Malignancy Vaccination Registry
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025


Group/Cohort
new B-Cell Hematologic Malignancy diagnosis
All adult patients who are newly diagnosed at Aurora Health Care with the following B-Cell Hematologic Malignancies: Monoclonal gammopathy of undetermined significance (MGUS), Smoldering multiple myeloma (SMM), Multiple myeloma (MM), Waldenstroms Macroglobulinemia (WM), Monoclonal B-cell lymphocytosis (MBL), Chronic lymphocytic leukemia (CLL), or B-Cell Non-Hodgkin lymphoma (NHL).



Primary Outcome Measures :
  1. vaccination history [ Time Frame: 10 years ]
    Information regarding vaccination history will be collected historically and throughout data collection, expected to continue for about 10 years.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]
    Survival status will be collected throughout data collection, expected to continue for about 10 years.

  2. infection [ Time Frame: 10 years ]
    Information about any infections (influenza, pneumonia, other) such as numbers, types will be collected throughout data collection, expected to continue for about 10 years.

  3. hospitalization rates [ Time Frame: 10 years ]
    Information regarding hospitalization will be collected throughout data collection, expected to continue for about 10 years.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients at Aurora Health Care who are newly diagnosed with:

  • Monoclonal gammopathy of undetermined significance (MGUS),
  • Smoldering multiple myeloma (SMM),
  • Multiple myeloma (MM),
  • Waldenstroms Macroglobulinemia (WM),
  • Monoclonal B-cell lymphocytosis (MBL),
  • Chronic lymphocytic leukemia (CLL), or
  • B-Cell Non-Hodgkin lymphoma (NHL).
Criteria

Inclusion Criteria:

  • Adult patients at Aurora Health Care who are newly diagnosed with:

    • Monoclonal gammopathy of undetermined significance (MGUS),
    • Smoldering multiple myeloma (SMM),
    • Multiple myeloma (MM),
    • Waldenstroms Macroglobulinemia (WM),
    • Monoclonal B-cell lymphocytosis (MBL),
    • Chronic lymphocytic leukemia (CLL), or
    • B-Cell Non-Hodgkin lymphoma (NHL).

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298816


Locations
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United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Michael A. Thompson, MD, PhD
Vince Lombardi Cancer Clinic
Investigators
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Principal Investigator: Michael Thompson, MD, PhD Aurora Health Care

Additional Information:

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Responsible Party: Michael A. Thompson, MD, PhD, Hematologist/Oncologist; Medical Director of Early Phase Cancer Research, Aurora Health Care
ClinicalTrials.gov Identifier: NCT02298816     History of Changes
Other Study ID Numbers: HMvax-registry:14-98E
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Keywords provided by Michael A. Thompson, MD, PhD, Aurora Health Care:
Monoclonal gammopathy of undetermined significance (MGUS)
Smoldering multiple myeloma (SMM)
Multiple myeloma (MM)
Waldenstroms Macroglobulinemia (WM)
Monoclonal B-cell lymphocytosis (MBL)
Chronic lymphocytic leukemia (CLL)
B-Cell Non-Hodgkin lymphoma (NHL)
B-Cell Hematologic Malignancies
immunization
Vaccination
Influenza, Human
Pneumonia

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Waldenstrom Macroglobulinemia
Lymphoma, Non-Hodgkin
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Lymphocytosis
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Lymphatic Diseases
Leukemia, B-Cell
Lymphoma
Hypergammaglobulinemia
Leukocytosis
Leukocyte Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs