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Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource (B-SCR-MM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01408225
Recruitment Status : Recruiting
First Posted : August 3, 2011
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ashley Rosko, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date August 1, 2011
First Posted Date August 3, 2011
Last Update Posted Date January 13, 2020
Actual Study Start Date March 17, 2011
Estimated Primary Completion Date March 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2012)
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 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01408225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 28, 2012)
  • Surveillance [ Time Frame: up to 3 years ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
Official Title Buckeye Surveillance, Contact, and Research for Multiple Myeloma and Amyloidosis
Brief 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.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated or diagnosed within the state of Ohio
Condition
  • Plasma Cell Dyscrasias
  • Monoclonal Gammopathy of Undetermined Significance
  • AL Amyloidosis
  • Multiple Myeloma
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 2, 2011)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2050
Estimated Primary Completion Date March 2050   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01408225
Other Study ID Numbers OSU-10115
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ashley Rosko, Ohio State University Comprehensive Cancer Center
Study Sponsor Ohio State University Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Ashley Rosko, MD Ohio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date January 2020