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

Multiple Myeloma Clinical Trial

— B-SCR-MM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01408225
• Other study ID #: OSU-10115
• Status: Recruiting
• Start date: March 17, 2011
• Est. completion date: March 2050

Study information

• Verified date: October 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehensive Cancer Center
• Phone: 1-800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 2050
• Est. primary completion date: March 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloidosis
• Immunoglobulin Light-chain Amyloidosis
• Monoclonal Gammopathy of Undetermined Significance
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Plasma Cell Dyscrasias

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surveillance	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.	up to 3 years
Secondary	Contact	Provide two-way communication with patients by providing information regarding multiple myeloma, local support groups, and standard of care procedures through active contact procedures	up to 3 years
Secondary	Research	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.	up to 3 years