Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource (B-SCR-MM)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01408225
First received: August 1, 2011
Last updated: October 14, 2014
Last verified: October 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Plasma Cell Dyscrasias Monoclonal Gammopathy of Undetermined Significance AL Amyloidosis Multiple Myeloma |
Procedure: tissue banking |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 10 Years |
| Official Title: | Buckeye Surveillance, Contact, and Research for Multiple Myeloma and Amyloidosis |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
AL Amyloidosis
Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma
U.S. FDA Resources
Further study details as provided by Ohio State University Comprehensive Cancer Center:
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Surveillance [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]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.
- Contact [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]Provide two-way communication with patients by providing information regarding multiple myeloma, local support groups, and standard of care procedures through active contact procedures
- Research [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 5000 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | March 2021 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated or diagnosed within the state of Ohio
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408225
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408225
Locations
| United States, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Nita Williams 614-293-3818 admin@ohiomyeloma.org | |
| Principal Investigator: Craig C Hofmeister, MD | |
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
| Principal Investigator: | Craig C Hofmeister, MD | Ohio State University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Craig Hofmeister, Principal Investigator, Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01408225 History of Changes |
| Other Study ID Numbers: | OSU-10115 |
| Study First Received: | August 1, 2011 |
| Last Updated: | October 14, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University Comprehensive Cancer Center:
|
MGUS Multiple Myeloma Tissue Bank |
Additional relevant MeSH terms:
|
Amyloidosis Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Neoplasms, Plasma Cell Paraproteinemias Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders |
Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Proteostasis Deficiencies Vascular Diseases |
ClinicalTrials.gov processed this record on February 26, 2015