NCT02298816

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 3, 2024

Status Verified

March 1, 2024

Enrollment Period

10.3 years

First QC Date

November 20, 2014

Last Update Submit

October 1, 2024

Conditions

Monoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaWaldenstrom MacroglobulinemiaLymphocytosisLymphoma, Non-HodgkinB-Cell Chronic Lymphocytic LeukemiaHematological Malignancies

Keywords

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 MalignanciesimmunizationVaccinationInfluenza, HumanPneumonia

Outcome Measures

Primary Outcomes (1)

  • vaccination history

    Information regarding vaccination history will be collected historically and throughout data collection, expected to continue for about 10 years.

    10 years

Secondary Outcomes (3)

  • Survival

    10 years

  • infection

    10 years

  • hospitalization rates

    10 years

Study Arms (1)

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).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora Health Care

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaWaldenstrom MacroglobulinemiaLymphocytosisLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellHematologic NeoplasmsSmoldering Multiple MyelomaLymphoma, B-CellInfluenza, HumanPneumonia

Condition Hierarchy (Ancestors)

HypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesParaproteinemiasImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesLeukocytosisLeukocyte DisordersLymphomaLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SitePrecancerous ConditionsRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesLung Diseases

Study Officials

  • Michael Thompson, MD, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

October 3, 2024

Record last verified: 2024-03

Locations

US(1)