A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles
Brief SummaryThe 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 DescriptionUnderstanding 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.
Inclusion and Exclusion 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.
- Robert Moss, Inc, Fountain Valley, California, 92708
- VA San Diego Healthcare System, San Diego, California, 92161
- Sharp Health Care, San Diego, California, 92123
- UC San Diego Moores Cancer Center, San Diego, California, 92093
- Bay Area Cancer Research Group LLC, Pleasant Hill, California, 94523
- UCSF Medical Center, San Francisco, California, 94143
- San Francisco VA Medical Center, San Francisco, California, 94121
- Mayo Clinic Campus in Scottsdale, AZ, Scottsdale, Arizona, 85259
- Northwest Cancer Specialists, PC, Tualatin, Oregon, 97062
- Oregon Health and Science University, Portland, Oregon, 97239
- Rocky Mountain Cancer Centers, Denver, Colorado, 80218
- Kaiser Permanente of Colorado, Denver, Colorado, 80205
- Yakima Valley Memorial Hospital/North Star Lodge, Yakima, Washington, 98902
- Cancer Care Northwest, Spokane, Washington, 99202
- Billings Clinic, Billings, Montana, 59101
- Cancer Center of Kansas, Wichita, Kansas, 67214
- Cancer Care Centers of South Texas, San Antonio, Texas, 78217
- Texas Oncology- Waco, Waco, Texas, 76712
- Central Texas VA Healthcare Center, Temple, Texas, 76504
- Baylor Research Institute, Dallas, Texas, 75246
- University of Texas Southwest Medical Center, Dallas, Texas, 75390
- Texas Oncology - Tyler, Tyler, Texas, 75702
- University of Nebraska Medical Center, Omaha, Nebraska, 68198
- Kansas City VA Medical Center, Kansas City, Missouri, 64128
- Washington University, St Louis, Missouri, 63110
- Mayo Clinic-Rochester, Rochester, Minnesota, 55905
- University of Mississippi Medical Center, Jackson, Mississippi, 39216
- Marshfield Clinic, Marshfield, Wisconsin, 54449
- Illinois Cancer Specialists, Niles, Illinois, 60714
- University of Chicago, Chicago, Illinois, 60637
- Sarah Cannon Research Institute, Nashville, Tennessee, 37203
- Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, 49503
- University of Cincinnati, Cincinnati, Ohio, 45267
- Winship Cancer Institute - Emory University, Atlanta, Georgia, 30322
- Atlanta VA Medical Center, Decatur, Georgia, 30033
- Hospital Clinica Universitari Lozano Blesa, Zaragoza, Aragón, 50012
- Hospital Universitari de Canarias, Tenerife, Santa Cruz, 38320