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.
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.
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.
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There are 72 Locations for this study
Scottsdale Arizona, 85259, United States
San Diego California, 92093, United States
San Diego California, 92123, United States
San Diego California, 92161, United States
San Francisco California, 94121, United States
San Francisco California, 94143, United States
Denver Colorado, 80205, United States
Denver Colorado, 80218, United States
Stamford Connecticut, 06907, United States
Washington District of Columbia, 20422, United States
Ocala Florida, 34471, United States
Atlanta Georgia, 30322, United States
Decatur Georgia, 30033, United States
Chicago Illinois, 60637, United States
Niles Illinois, 60714, United States
Wichita Kansas, 67214, United States
Salisbury Maryland, 21801, United States
Silver Spring Maryland, 20902, United States
Detroit Michigan, 48201, United States
Grand Rapids Michigan, 49503, United States
Rochester Minnesota, 55905, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64128, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68198, United States
Lebanon New Hampshire, 03784, United States
Hackensack New Jersey, 07601, United States
Livingston New Jersey, 07039, United States
Bronx New York, 10469, United States
Johnson City New York, 13790, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10065, United States
New York New York, 10065, United States
Roslyn New York, 11576, United States
Cary North Carolina, 27518, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27834, United States
Pinehurst North Carolina, 28374, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97239, United States
Tualatin Oregon, 97062, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78217, United States
Temple Texas, 76504, United States
Tyler Texas, 75702, United States
Waco Texas, 76712, United States
Fairfax Virginia, 22013, United States
Spokane Washington, 99202, United States
Yakima Washington, 98902, United States
Marshfield Wisconsin, 54449, United States
Calgary Alberta, T2N 2, Canada
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3A1A, Canada
Zaragoza Aragón, 50012, Spain
Salamanca Castilla-León, 37007, Spain
Badalona Cataluña, 08916, Spain
Palma de Mallorca Islas Baleares, 07120, Spain
Palma de Mallorca Islas Baleares, 07198, Spain
Pozuelo de Alarcón Madrid, 28223, Spain
San Sebastián de los Reyes Madrid, 28702, Spain
Pamplona Navarra, 31008, Spain
Tenerife Santa Cruz, 38320, Spain
Barcelona , 08003, Spain
Barcelona , 08026, Spain
Barcelona , 08036, Spain
Madrid , 28034, Spain
Madrid , 28222, Spain
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