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The Indiana Myeloma Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616483
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Mohammad Abu Zaid, M.D., Indiana University

Study Description
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Brief Summary:
This is a prospective, non-interventional, observational study. The purpose of this study is to collect data and bio-specimens that will support future research

Condition or disease Intervention/treatment
Plasma Cell Dyscrasias Other: This is a non-interventional trial

Study Design
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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Specimens and Clinical Data to Create A Bio-repository for the Multiple Myeloma Program: The Indiana Myeloma Registry
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : June 30, 2028
Estimated Study Completion Date : June 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Intervention Details:
  • Other: This is a non-interventional trial
    This is a non-interventional trial

Outcome Measures
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Primary Outcome Measures :
  1. Create a repository [ Time Frame: 5 years ]
    The primary objective of this study is to provide a mechanism to store comprehensive clinical, genomic, demographic, social, environmental and quality of life data from subjects with plasma cell dyscrasias


Secondary Outcome Measures :
  1. Data collection [ Time Frame: 5 years ]
    To collect data related to clonal evolution, tumor microenvironment, clinical outcomes, adverse events, environmental factors and quality of life that will provide the foundation to create hypotheses for future confirmatory studies.


Biospecimen Retention:   Samples With DNA
saliva, blood, bone marrow aspirate

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients disgnosed with one of the following:

  1. Monoclonal Gammopathy of Undetermined Significance (MGUS)
  2. Smoldering Multiple Myeloma
  3. Multiple Myeloma
  4. Bony or Soft Tissue Plasmacytoma
  5. Primary Amyloidosis
Criteria

Inclusion Criteria:

  1. Male or female patients ≥ 18 years of age at the time of informed consent

  2. Has been diagnosed with or is suspected to have one of the following:

    1. Monoclonal Gammopathy of Undetermined Significance (MGUS)
    2. Smoldering Multiple Myeloma
    3. Multiple Myeloma
    4. Bony or Soft Tissue Plasmacytoma
    5. Primary Amyloidosis

Exclusion Criteria:

< 18 years of age

Have not been diagnosed with one of the following:

Monoclonal Gammopathy of Undetermined Significance (MGUS) b.Smoldering Multiple Myeloma c.Multiple Myeloma d.Bony or Soft Tissue Plasmacytoma e.Primary Amyloidosis

Contacts and Locations
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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): NCT03616483


Contacts
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Contact: Mohammad Abu Zaid, MD 317-278-0626 MABUZAID@IU.EDU

Locations
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United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mohammad Abu Zaid, MD    317-948-7038    mabuzaid@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Mohammad Abu Zaid, MD Indiana University School of Medicine
More Information
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Responsible Party: Mohammad Abu Zaid, M.D., Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03616483    
Other Study ID Numbers: IUSCC-0661
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammad Abu Zaid, M.D., Indiana University:
Multiple myeloma
Monoclonal gammopathy of undetermined significance
Plasmacytoma
Smoldering multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
 Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases