Plasma Cell DyscrasiasNCT03616483
The Indiana Myeloma Registry
An observational study of Plasma Cell Dyscrasias, run by Indiana University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Dyscrasias
- What is being tested?
- This is a non-interventional trial
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- < 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Attaya Suvannasankha, MD, 317-274-0843, asuvanna@iu.edu
Nisha George, MD, (317) 274-6635, nishgeor@iu.edu
About this study
Official title: 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
- Conditions
- Plasma Cell Dyscrasias
- Being tested
- This is a non-interventional trial
- Keywords
- Multiple myeloma, Monoclonal gammopathy of undetermined significance, Plasmacytoma, Smoldering multiple myeloma
- Medical subject headings
- Paraproteinemias, Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Plasmacytoma, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional trialOther
This is a non-interventional trial
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start18 Jun 2018
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell DyscrasiasStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Attaya Suvannasankha, Indiana University
- Investigators
- Attaya Suvannasankha, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616483
- Sponsor's protocol ID
- IUSCC-0661
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2018
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Specimens and Clinical Data to Create A Bio-repository for the Multiple Myeloma Program: The Indiana Myeloma Registry
- ClinicalTrials.gov ID
- NCT03616483
- Acronym / sponsor ID
- IUSCC-0661
- Conditions
- Plasma Cell Dyscrasias
- Keywords
- Multiple myeloma, Monoclonal gammopathy of undetermined significance, Plasmacytoma, Smoldering multiple myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (3 listed)
- < 18 years of age
- Monoclonal Gammopathy of Undetermined Significance (MGUS) b.Smoldering Multiple Myeloma c.Multiple Myeloma d.Bony or Soft Tissue Plasmacytoma e.Primary Amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional trialThis is a non-interventional trial | Other | – |
Primary outcome
Create a repository
Time frame: 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
1 secondary outcome
Data collection
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Attaya Suvannasankha, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Cell Dyscrasias, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Attaya Suvannasankha, MD (317-274-0843, asuvanna@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a repository (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.