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 30% 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 30% 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).
Name: Abemaciclib, dexamethasone, ixazomib, pomalidomide
Name: Enasidenib, dexamethasone, ixazomib, pomalidomide
Name: Cobimetinib, dexamethasone, ixazomib, pomalidomide
Name: Erdafitinib, dexamethasone, ixazomib, pomalidomide
Name: Venetoclax, dexamethasone, ixazomib, pomalidomide
Name: Daratumumab, dexamethasone, ixazomib, pomalidomide
Description: • To evaluate the overall response rate (ORR) with targeted agents used in combination with backbone regimen ixazomib, pomalidomide and dexamethasone (IPd) in patients with an actionable genetic alteration per the International Myeloma Working Group [IMWG] consensus criteria (Kumar et al, 2016)
Measure: Overall Response Rate - Actionable Genetic Alteration Time: Patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 yearsDescription: • To evaluate the ORR with agents used in combination with backbone (or IPd) regimen in patients with no actionable genetic alteration per IMWG consensus criteria (Kumar et al, 2016).
Measure: Overall Response Rate - Non-Actionable Genetic Alteration Time: Patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 yearsAllocation: Non-Randomized
Parallel Assignment
There is one SNP
Patients with a greater than 30% 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. --- V600E ---