Clinical Trials /

Collection of Specimens and Clinical Data to Create A Bio-repository for Multiple Myeloma

NCT03616483

Description:

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

Related Conditions:
  • Monoclonal Gammopathy of Undetermined Significance
  • Multiple Myeloma
  • Plasmacytoma
  • Primary Amyloidosis
  • Smoldering Plasma Cell Myeloma
Recruiting Status:

Recruiting

URL:

https://clinicaltrials.gov/show/NCT03616483

Trial Eligibility

Document

Title

  • Brief Title: Collection of Specimens and Clinical Data to Create A Bio-repository for Multiple Myeloma
  • Official Title: Collection of Specimens and Clinical Data to Create A Bio-repository for the Multiple Myeloma Program: The Indiana Myeloma Registry

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0661
  • NCT ID: NCT03616483

Conditions

  • Plasma Cell Dyscrasias

Purpose

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

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Create a repository
Time Frame:5 years
Safety Issue:
Description: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

Measure:Data collection
Time Frame:5 years
Safety Issue:
Description: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.

Details

Phase:
Primary Purpose:Observational
Overall Status:Recruiting
Lead Sponsor:Indiana University

Trial Keywords

  • Multiple myeloma
  • Monoclonal gammopathy of undetermined significance
  • Plasmacytoma
  • Smoldering multiple myeloma

Last Updated

February 15, 2021