The Indiana Myeloma Registry

Plasma Cell Dyscrasias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03616483
• Other study ID #: IUSCC-0661
• Status: Recruiting
• Start date: June 18, 2018
• Est. completion date: June 30, 2028

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: Rafat Abonour, MD
• Phone: 317-944-0920
• Email: rabonour[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Plasma Cell Dyscrasias

Intervention

Other:
• This is a non-interventional trial
This is a non-interventional trial

Locations

Country	Name	City	State
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Create a repository	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	5 years
Secondary	Data collection	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.	5 years