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:
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

August 1, 2011
October 14, 2014
March 2011
March 2021   (final data collection date for primary outcome 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 [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01408225 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
Buckeye Surveillance, Contact, and Research for Multiple Myeloma and Amyloidosis

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
10 Years
Not Provided
Non-Probability Sample

Patients treated or diagnosed within the state of Ohio

  • Plasma Cell Dyscrasias
  • Monoclonal Gammopathy of Undetermined Significance
  • AL Amyloidosis
  • Multiple Myeloma
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
Not Provided
March 2021   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
United States
 
NCT01408225
OSU-10115
Yes
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Craig C Hofmeister, MD Ohio State University
Ohio State University Comprehensive Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP