The Indiana Myeloma Registry | NCT03616483

Studies
The Indiana Myeloma Registry

NCT03616483

Sponsor

Indiana University

Status

Recruiting

Last Update Posted

Nov 10, 2025Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Plasma Cell Dyscrasias

Interventions

This is a non-interventional trial

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2018Actual

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Jul 22, 2018

First Submission Date that Met QC Criteria

Jul 31, 2018

First Posted Date

Aug 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2025

Last Update Posted Date

Nov 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,500Estimated

Name	Type	Description	Arm Group Labels	Other Names
This is a non-interventional trial	Other	This is a non-interventional trial

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients disgnosed with one of the following:

Monoclonal Gammopathy of Undetermined Significance (MGUS)
Smoldering Multiple Myeloma
Multiple Myeloma
Bony or Soft Tissue Plasmacytoma
Primary Amyloidosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Attaya Suvannasankha, MD	Contact	317-274-0843		asuvanna@iu.edu
Nisha George, MD	Contact	(317) 274-6635		nishgeor@iu.edu

Overall Officials

Name	Affiliation	Role
Attaya Suvannasankha, MD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University Simon Cancer Center	Recruiting	Indianapolis	Indiana	46202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010265	Paraproteinemias
D009101	Multiple Myeloma
D008998	Monoclonal Gammopathy of Undetermined Significance
D010954	Plasmacytoma
D000075122	Smoldering Multiple Myeloma

Ancestor Terms

ID	Term
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided