Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
NCT ID: NCT01454297
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1154 participants
OBSERVATIONAL
2011-07-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newly diagnosed Multiple Myeloma
This is a prospective observational study in patients with symptomatic multiple myeloma who have not yet initiated therapy for their disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:
Serum M protein ≥ 1g/dl Urine M protein ≥ 200 mg/24 hrs Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
* The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
* No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
* Patient has read, understood and signed informed consent.
Exclusion Criteria
* Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
* Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.
18 Years
ALL
No
Sponsors
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Translational Genomics Research Institute
OTHER
Spectrum Health Hospitals
OTHER
Van Andel Research Institute
OTHER
Multiple Myeloma Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Daniel Auclair
Role: STUDY_DIRECTOR
Multiple Myeloma Research Foundation
Locations
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Mayo Clinic Campus in Scottsdale, AZ
Scottsdale, Arizona, United States
UC San Diego Moores Cancer Center
San Diego, California, United States
Sharp Health Care
San Diego, California, United States
VA San Diego Healthcare System
San Diego, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Kaiser Permanente of Colorado
Denver, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Carl and Dorothy Bennett Cancer Center
Stamford, Connecticut, United States
VA Medical Center, Washington DC,
Washington D.C., District of Columbia, United States
Ocala Oncology Center
Ocala, Florida, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Peninsula Regional Cancer Center
Salisbury, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Broome Oncology
Johnson City, New York, United States
New York University Medical Center
New York, New York, United States
Mt Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College-NY Presbyterian Hospital
New York, New York, United States
St Francis Hospital
Roslyn, New York, United States
Eastchester Center for Cancer Care
The Bronx, New York, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
First Health Outpatient Cancer Center
Pinehurst, North Carolina, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
University of Texas Southwest Medical Center
Dallas, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Central Texas VA Healthcare Center
Temple, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Texas Oncology- Waco
Waco, Texas, United States
Virginia Cancer Specialists PV
Fairfax, Virginia, United States
Cancer Care Northwest
Spokane, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Tom Baker Cancer Centre, Alberta Health Services
Calgary, Alberta, Canada
Cross Cancer Institute, Alberta Health Services
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, Canada
Hospital Clinica Universitari Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Univ Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Son Llàtze
Palma de Mallorca, Balearic Islands, Spain
Hospital University de Salamanca
Salamanca, Castille and León, Spain
H. U. Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital Quirón de Madrid
Pozuelo de Alarcón, Madrid, Spain
University Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitari de Canarias
Santa Cruz de Tenerife, Santa Cruz, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
Countries
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References
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Auclair D, Mansfield C, Fiala MA, Chari A, Cole CE, Kaufman JL, Orloff GJ, Siegel DS, Zonder JA, Mange B, Yesil J, Dalal M, Mikhael JR. Preferences and Priorities for Relapsed Multiple Myeloma Treatments Among Patients and Caregivers in the United States. Patient Prefer Adherence. 2022 Mar 1;16:573-585. doi: 10.2147/PPA.S345906. eCollection 2022.
Barwick BG, Gupta VA, Matulis SM, Patton JC, Powell DR, Gu Y, Jaye DL, Conneely KN, Lin YC, Hofmeister CC, Nooka AK, Keats JJ, Lonial S, Vertino PM, Boise LH. Chromatin Accessibility Identifies Regulatory Elements Predictive of Gene Expression and Disease Outcome in Multiple Myeloma. Clin Cancer Res. 2021 Jun 1;27(11):3178-3189. doi: 10.1158/1078-0432.CCR-20-2931. Epub 2021 Mar 17.
Foltz SM, Gao Q, Yoon CJ, Sun H, Yao L, Li Y, Jayasinghe RG, Cao S, King J, Kohnen DR, Fiala MA, Ding L, Vij R. Evolution and structure of clinically relevant gene fusions in multiple myeloma. Nat Commun. 2020 May 29;11(1):2666. doi: 10.1038/s41467-020-16434-y.
Miller A, Asmann Y, Cattaneo L, Braggio E, Keats J, Auclair D, Lonial S; MMRF CoMMpass Network; Russell SJ, Stewart AK. High somatic mutation and neoantigen burden are correlated with decreased progression-free survival in multiple myeloma. Blood Cancer J. 2017 Sep 22;7(9):e612. doi: 10.1038/bcj.2017.94.
Related Links
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The Multiple Myeloma Research Foundation
Other Identifiers
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MMRF-11-001
Identifier Type: -
Identifier Source: org_study_id
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