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 April 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01408225
First received: August 1, 2011
Last updated: April 4, 2014
Last verified: April 2014
  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:


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:
    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.
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

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

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: William Falk    614-293-3818    William.Falk@osumc.edu   
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: April 4, 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
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell
Proteostasis Deficiencies
Metabolic Diseases
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 15, 2014