Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT01408225
Study Start
Primary Completion
Study Completion
Enrollment
5000
Study Type
Observational
Interventions
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 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
Description

Establish a database of myeloma patients diagnosed or living in the state of Ohio to track myeloma disease course, patient reported outcomes, morbidity, and patient survival.

Timeframe
up to 3 years
Measure
Contact
Description

Provide two-way communication with patients by providing information regarding multiple myeloma, local support groups, and standard of care procedures through active contact procedures

Timeframe
up to 3 years
Measure
Research
Description

Offer patients, and occasionally spouses and family members, the opportunity to participate in tissue banking, observational, patient reported outcomes, and therapeutic clinical trials for their plasma cell dyscrasia.

Timeframe
up to 3 years
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.

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.

Conditions
Plasma Cell Dyscrasias
Monoclonal Gammopathy of Undetermined Significance
AL Amyloidosis
Multiple Myeloma
Study Contact
Name
The Ohio State University Comprehensive Cancer Center
Role
Contact
Phone
1-800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Locations
Facility

Ohio State University Medical Center
Columbus, OH 43210
United States

Contacts
Study Contact
Name
Don Benson, MD
Role
Principal Investigator
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.

Eligibility Minimum Age
18 Years
Sexes Eligible for Study
ALL
Eligibility Std Ages
Adult
Older Adult
Study Population

Patients treated or diagnosed within the state of Ohio