NCT03616483

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2018Jun 2028

Study Start

First participant enrolled

June 18, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

November 10, 2025

Status Verified

October 1, 2025

Enrollment Period

10 years

First QC Date

July 22, 2018

Last Update Submit

November 6, 2025

Conditions

Plasma Cell Dyscrasias

Keywords

Multiple myelomaMonoclonal gammopathy of undetermined significancePlasmacytomaSmoldering multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Data collection

    5 years

Interventions

This is a non-interventional trialOTHER

This is a non-interventional trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

saliva, blood, bone marrow aspirate

MeSH Terms

Conditions

ParaproteinemiasMultiple MyelomaMonoclonal Gammopathy of Undetermined SignificancePlasmacytomaSmoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Blood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersLymphoproliferative DisordersHypergammaglobulinemiaPrecancerous Conditions

Study Officials

  • Attaya Suvannasankha, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Attaya Suvannasankha, MD

CONTACT

317-274-0843asuvanna@iu.edu

Nisha George, MD

CONTACT

(317) 274-6635nishgeor@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Clinical Medicine

Study Record Dates

First Submitted

July 22, 2018

First Posted

August 6, 2018

Study Start

June 18, 2018

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

November 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)