Clinical trial NCT01408225: Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
Official title: Buckeye Surveillance, Contact, and Research for Multiple Myeloma and Amyloidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plasma Cell Dyscrasias
Monoclonal Gammopathy of Undetermined Significance
AL Amyloidosis
Multiple Myeloma
Keywords: MGUS
Multiple Myeloma
Tissue Bank
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated or diagnosed within the state of Ohio

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.

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.

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.

Primary outcomes:
measure: 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
timeFrame: up to 3 years
Secondary outcomes:
measure: Surveillance
timeFrame: up to 3 years
measure: Contact
timeFrame: up to 3 years
measure: Research
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Don Benson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.