Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
- Conditions
- Multiple Myeloma
- Registration Number
- NCT01454297
- Lead Sponsor
- Multiple Myeloma Research Foundation
- Brief Summary
The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.
- Detailed Description
Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1154
- Patient is at least 18 years old.
- 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.
- Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. Baseline to 8 years. Standard clinical and laboratory assessments. Genomic tests (DNA and RNA sequencing, etc.) on bone marrow aspirates obtained at baseline, suspected complete response, and relapse/progression.
- Secondary Outcome Measures
Name Time Method Resource utilization Baseline and during five to eight years of follow-up Hospitalizations and ER visits
Response rates Up to one year after baseline. IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.
Survival rates Five to eight years after baseline Progression-free survival and overall survival
Bone disease assessed radiographically Baseline and during five to eight years of follow-up Health-related quality of life Baseline and during five to eight years of follow-up EORTC QLQ-C30 and QLQ-MY20
Severe adverse events Five to eight years Severe/CTCAE grade 3-4 adverse events (checklist)
Trial Locations
- Locations (73)
East Carolina University
🇺🇸Greenville, North Carolina, United States
Winship Cancer Institute - Emory University
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Peninsula Regional Cancer Center
🇺🇸Salisbury, Maryland, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, 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
Billings Clinic
🇺🇸Billings, Montana, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Broome Oncology
🇺🇸Johnson City, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
New York University Medical Center
🇺🇸New York, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Mayo Clinic Campus in Scottsdale, AZ
🇺🇸Scottsdale, Arizona, United States
Carl and Dorothy Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
VA Medical Center, Washington DC,
🇺🇸Washington, District of Columbia, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, 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
Central Texas VA Healthcare Center
🇺🇸Temple, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Texas Oncology- Waco
🇺🇸Waco, Texas, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
St Francis Hospital
🇺🇸Roslyn, New York, United States
Mt Sinai Medical Center
🇺🇸New York, New York, United States
Northwest Cancer Specialists, PC
🇺🇸Tualatin, Oregon, United States
Waverly Hematology Oncology
🇺🇸Cary, North Carolina, United States
First Health Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Yakima Valley Memorial Hospital/North Star Lodge
🇺🇸Yakima, Washington, United States
University of Texas Southwest Medical Center
🇺🇸Dallas, Texas, United States
Virginia Cancer Specialists PV
🇺🇸Fairfax, Virginia, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
McGill University Health Center, Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Hospital Clinica Universitari Lozano Blesa
🇪🇸Zaragoza, Aragón, Spain
Hospital University de Salamanca
🇪🇸Salamanca, Castilla-León, Spain
ClÃnica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
H. U. Germans Trias i Pujol
🇪🇸Badalona, Cataluña, Spain
Hospital Univ Son Espases
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Hospital Quirón de Madrid
🇪🇸Pozuelo de Alarcón, Madrid, Spain
Hospital Son Llà tze
🇪🇸Palma de Mallorca, Islas Baleares, Spain
University Hospital Infanta Sofia
🇪🇸San Sebastián de los Reyes, Madrid, Spain
Hospital Universitari de Canarias
🇪🇸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
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
Sharp Health Care
🇺🇸San Diego, California, United States
UC San Diego Moores Cancer Center
🇺🇸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
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mayo Clinic-Rochester
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
Eastchester Center for Cancer Care
🇺🇸Bronx, New York, United States