Multiple Myeloma CoMMpass Study

The Multiple Myeloma Research Foundation (MMRF) CoMMpass (Relating Clinical Outcomes in MM to Personal Assessment of Genetic Profile) trial (NCT01454297) is a longitudinal observation study of 1000 newly diagnosed myeloma patients receiving various standard approved treatments that aim at collecting tissue samples, genetic information, Quality of Life (QoL) and various disease and clinical outcomes over 10 years.]]> The treatment regimen selected for the patient is at the discretion of the treating investigator. However, the initial regimen must contain an FDA-approved IMiD® and/or a proteasome inhibitor. Other than this requirement, the study does not dictate dose, schedule or any other specific treatment requirement. 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. ]]> The study was initiated in 2011.]]>