NCT01408225

Brief Summary

The investigators are researching patients with diseases of their plasma cells in order to improve their quality and length of life. The investigators have created a database of patient information, blood samples, and bone marrow tissue in order to achieve the following three goals:

  • Surveillance: The investigators want to track what treatments patients get or don't get, how effective they are, how they feel, what complications they suffer, how long they stay in remission, and how long they live.
  • Contact: Because myeloma and amyloidosis are rare, less than 700 patients are diagnosed in the state of Ohio each year, patients often feel they don't have accurate information. The investigators want to provide them access to our clinical team (both phone and email consultations, even office visits for patients that can come to Columbus) as well as information regarding informational events pertaining to your disease and local support groups.
  • Research: Because nearly all myeloma and amyloid patients relapse and treatment is eventually unsuccessful, our focus is to develop more effective treatments that not only prolong life, but cure the disease. Periodically the investigators will inform them about clinical trials studying new drugs or treatment paradigms.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
290mo left

Started Mar 2011

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 Progress39%
Mar 2011Mar 2050

Study Start

First participant enrolled

March 17, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
38.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2050

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

39 years

First QC Date

August 1, 2011

Last Update Submit

March 18, 2026

Conditions

Keywords

MGUSMultiple MyelomaTissue Bank

Outcome Measures

Primary Outcomes (1)

  • Develop a data and sample resource that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality of patients diagnosed or living with Multiple Myeloma in the state of Ohio

    up to 3 years

Secondary Outcomes (3)

  • Surveillance

    up to 3 years

  • Contact

    up to 3 years

  • Research

    up to 3 years

Interventions

tissue procurement for this protocol will occur at the time of initial diagnosis, during routine follow-up, or at the time of relapse.

Eligibility Criteria

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

Patients treated or diagnosed within the state of Ohio

You may qualify if:

  • Diagnosis of a plasma cell dyscrasia

You may not qualify if:

  • Prisoners are excluded from participation as they have no standard access to the Ohio State myeloma clinic and would impede the research objective of this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

  • Khalife J, Ghose J, Martella M, Viola D, Rocci A, Troadec E, Terrazas C, Satoskar AR, Gunes EG, Dona A, Sanchez JF, Bergsagel PL, Chesi M, Pozhitkov A, Rosen S, Marcucci G, Keats JJ, Hofmeister CC, Krishnan A, Caserta E, Pichiorri F. MiR-16 regulates crosstalk in NF-kappaB tolerogenic inflammatory signaling between myeloma cells and bone marrow macrophages. JCI Insight. 2019 Nov 1;4(21):e129348. doi: 10.1172/jci.insight.129348.

Biospecimen

Retention: SAMPLES WITH DNA

blood and bone marrow

MeSH Terms

Conditions

ParaproteinemiasMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain AmyloidosisMultiple Myeloma

Interventions

Tissue Banks

Condition Hierarchy (Ancestors)

Blood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHypergammaglobulinemiaNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Biological Specimen BanksHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Don Benson, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

March 17, 2011

Primary Completion (Estimated)

March 1, 2050

Study Completion (Estimated)

March 1, 2050

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations