The Indiana Myeloma Registry

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03616483

Collaborator

(none)

2,500

Enrollment

Location

120.4

Anticipated Duration (Months)

20.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Plasma Cell Dyscrasias	Other: This is a non-interventional trial

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 18, 2018

Anticipated Primary Completion Date :

Jun 30, 2028

Anticipated Study Completion Date :

Jun 30, 2028

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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