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Recruiting NCT01408225

Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource

Observational Plasma Cell Dyscrasias Monoclonal Gammopathy of Undetermined Significance AL Amyloidosis Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tissue banking.
Who it may be relevant to
Registry conditions: Plasma Cell Dyscrasias, Monoclonal Gammopathy of Undetermined Significance, AL Amyloidosis, Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Buckeye Surveillance, Contact, and Research for Multiple Myeloma and Amyloidosis

Overview

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.

Detailed description

The investigators propose to contact and interact with all patients with plasma cell dyscrasias in the State of Ohio (and all patients diagnosed or treated at Ohio State Medical Center) for both surveillance and research purposes in order to develop interventions targeted to decrease their morbidity and mortality.

Interventions

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

Primary outcome measures

  • 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 [Time frame: up to 3 years]
Secondary outcome measures (3)
  • Surveillance [Time frame: up to 3 years]
  • Contact [Time frame: up to 3 years]
  • Research [Time frame: up to 3 years]

Eligibility criteria

Inclusion:

Diagnosis of a plasma cell dyscrasia

Exclusion:

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Ohio State University Medical Center — Columbus

Publications

  • 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. d PMID 31593552

Identifiers

NCT: NCT01408225 · OSU-10115

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗