Multiple Myeloma Clinical Trial

Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 is for people with:

Multiple Myeloma

Estimated Enrollment:

1154

Study ID:

NCT01454297

Recruitment Status:

Completed

Sponsor:

Multiple Myeloma Research Foundation

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There are 72 Locations for this study

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Mayo Clinic Campus in Scottsdale, AZ
Scottsdale Arizona, 85259, United States
UC San Diego Moores Cancer Center
San Diego California, 92093, United States
Sharp Health Care
San Diego California, 92123, United States
VA San Diego Healthcare System
San Diego California, 92161, United States
San Francisco VA Medical Center
San Francisco California, 94121, United States
UCSF Medical Center
San Francisco California, 94143, United States
Kaiser Permanente of Colorado
Denver Colorado, 80205, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
Carl and Dorothy Bennett Cancer Center
Stamford Connecticut, 06907, United States
VA Medical Center, Washington DC,
Washington District of Columbia, 20422, United States
Ocala Oncology Center
Ocala Florida, 34471, United States
Winship Cancer Institute - Emory University
Atlanta Georgia, 30322, United States
Atlanta VA Medical Center
Decatur Georgia, 30033, United States
University of Chicago
Chicago Illinois, 60637, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Peninsula Regional Cancer Center
Salisbury Maryland, 21801, United States
Holy Cross Hospital
Silver Spring Maryland, 20902, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Grand Rapids Clinical Oncology Program
Grand Rapids Michigan, 49503, United States
Mayo Clinic-Rochester
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Kansas City VA Medical Center
Kansas City Missouri, 64128, United States
Washington University
Saint Louis Missouri, 63110, United States
Billings Clinic
Billings Montana, 59101, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03784, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Eastchester Center for Cancer Care
Bronx New York, 10469, United States
Broome Oncology
Johnson City New York, 13790, United States
New York University Medical Center
New York New York, 10016, United States
Mt Sinai Medical Center
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College-NY Presbyterian Hospital
New York New York, 10065, United States
St Francis Hospital
Roslyn New York, 11576, United States
Waverly Hematology Oncology
Cary North Carolina, 27518, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke University Hospital
Durham North Carolina, 27710, United States
East Carolina University
Greenville North Carolina, 27834, United States
First Health Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States
Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Northwest Cancer Specialists, PC
Tualatin Oregon, 97062, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Baylor Research Institute
Dallas Texas, 75246, United States
University of Texas Southwest Medical Center
Dallas Texas, 75390, United States
Cancer Care Centers of South Texas
San Antonio Texas, 78217, United States
Central Texas VA Healthcare Center
Temple Texas, 76504, United States
Texas Oncology - Tyler
Tyler Texas, 75702, United States
Texas Oncology- Waco
Waco Texas, 76712, United States
Virginia Cancer Specialists PV
Fairfax Virginia, 22013, United States
Cancer Care Northwest
Spokane Washington, 99202, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima Washington, 98902, United States
Marshfield Clinic
Marshfield Wisconsin, 54449, United States
Tom Baker Cancer Centre, Alberta Health Services
Calgary Alberta, T2N 2, Canada
Cross Cancer Institute, Alberta Health Services
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
McGill University Health Center, Royal Victoria Hospital
Montreal Quebec, H3A1A, Canada
Hospital Clinica Universitari Lozano Blesa
Zaragoza Aragón, 50012, Spain
Hospital University de Salamanca
Salamanca Castilla-León, 37007, Spain
H. U. Germans Trias i Pujol
Badalona Cataluña, 08916, Spain
Hospital Univ Son Espases
Palma de Mallorca Islas Baleares, 07120, Spain
Hospital Son Llàtze
Palma de Mallorca Islas Baleares, 07198, Spain
Hospital Quirón de Madrid
Pozuelo de Alarcón Madrid, 28223, Spain
University Hospital Infanta Sofia
San Sebastián de los Reyes Madrid, 28702, Spain
Clínica Universitaria de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitari de Canarias
Tenerife Santa Cruz, 38320, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Santa Creu I Sant Pau
Barcelona , 08026, Spain
Hospital Clinic i Provincial
Barcelona , 08036, Spain
Hospital Ramón y Cajal
Madrid , 28034, Spain
Hospital Puerta de Hierro
Madrid , 28222, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

1154

Study ID:

NCT01454297

Recruitment Status:

Completed

Sponsor:


Multiple Myeloma Research Foundation

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