The Indiana Myeloma Registry

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03616483
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Indiana University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rafat Abonour, MD
Principal Investigator Affiliation Indiana University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasma Cell Dyscrasias

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Indiana University Simon Cancer Center, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202

Site Contact

Rafat Abonour, MD

rabonour@iu.edu

317-944-0920