The Indiana Myeloma Registry

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

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

Study Overview

• Status: Recruiting
• Conditions: Plasma Cell Dyscrasias
• Intervention / Treatment: Other: This is a non-interventional trial

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Attaya Suvannasankha, MD; Phone Number: 317-274-0843; Email: asuvanna@iu.edu
• Study Contact Backup: Name: Nisha George, MD; Phone Number: (317) 274-6635; Email: nishgeor@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Simon Cancer Center
      • Contact: Attaya Suvannasankha, MD; Phone Number: 317-274-0843; Email: asuvanna@iu.edu
      • Contact: Nisha George, MD; Phone Number: (317) 274-6635; Email: nishgeor@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Attaya Suvannasankha, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 22, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Multiple myeloma; Plasmacytoma; Smoldering multiple myeloma; Monoclonal gammopathy of undetermined significance
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Precancerous Conditions; Neoplasms, Plasma Cell; Hemostatic Disorders; Blood Protein Disorders; Hemorrhagic Disorders; Hypergammaglobulinemia; Hemic and Lymphatic Diseases; Smoldering Multiple Myeloma; Multiple Myeloma; Plasmacytoma; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
• Other Study ID Numbers: IUSCC-0661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No