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Brief Title: Myeloma-Developing Regimens Using Genomics (MyDRUG)
Official Title: Myeloma-Developing Regimens Using Genomics (MyDRUG) (Genomics Guided Multi-arm Trial of Targeted Agents Alone or in Combination With a Backbone Regimen)
Study ID: NCT03732703
Brief Summary: The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 25% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 25% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).
Detailed Description: The study will enroll 228 patients enrolled to one of eight treatment arms. The study is open to patients relapsing with relapsed refractory multiple myeloma, who have * received at least one prior but no more than 3 prior therapies * exposed to both a PI and an IMiD * had early relapse after initial treatment. Relapse is defined as the IMWG uniform response criteria (Kumar et al, 2016). Early relapse as defined by at least one of the following: 1. Relapse within 3 years post autologous stem cell transplantation (ASCT) on maintenance, or 18 months if unmaintained 2. Relapse within 18 months of initial non-ASCT based therapy
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic - Arizona, Phoenix, Arizona, United States
City of Hope, Duarte, California, United States
Emory University, Atlanta, Georgia, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Beth Israel Deaconess, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Mayo Clinic - Minnesota, Rochester, Minnesota, United States
Washington University School of Medicine Division of Medical Oncology, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Mount Sinai School of Medicine, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Ohio State University College of Medicine, Columbus, Ohio, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Name: Hearn J Cho, M.D., Ph.D.
Affiliation: Multiple Myeloma Research Consortium
Role: PRINCIPAL_INVESTIGATOR
Name: Daniel Auclair, Ph.D.
Affiliation: Multiple Myeloma Research Consortium
Role: PRINCIPAL_INVESTIGATOR