The Indiana Myeloma Registry

Recruiting

• Conditions: Plasma Cell Dyscrasias

• Registration Number: NCT03616483
• Lead Sponsor: Indiana University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-18
• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-30
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Create a repository	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

Name	Time	Method
Data collection	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.

Trial Locations

Locations (1)

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States