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).
The study will enroll 228 patients enrolled to one of six 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:
Experimental: Sub-Protocol A1
Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Experimental: Sub-Protocol B1
Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Experimental: Sub-Protocol C1
Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Experimental: Sub-Protocol D1
Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Experimental: Sub-Protocol E1
Patients with Plasma cell Fluorescence In Situ Hybridization (FISH) test demonstrating presence of t(11;14) receive Venetoclax in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Experimental: Sub-Protocol Y1
Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)
SparkCures ID | 983 |
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Trial Phase | Phase 1/2 |
Enrollment | 228 Patients |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Criteria:
Sub-Protocol Inclusion Criteria:
Refer to each respective Sub Protocol for additional inclusion criteria.
Exclusion Criteria:
Patients will be ineligible for this study if they meet any one of the following criteria:
Sub-Protocol Exclusion Criteria:
Refer to each respective Sub Protocol for additional exclusion criteria.
The following is a listing of trial locations that are open and accepting patients.
SparkCures Verified Accurate, up-to-date information. Learn more
Scottsdale, AZ
Boston, MA
Boston, MA
Ann Arbor, MI
Rochester, MN
Charlotte, NC
New York, NY
Fairfax, VA
The following is a listing of trial locations that are not currently open and accepting patients.
Boston, MA
Scottsdale, AZ
Boston, MA
Boston, MA
Boston, MA
Rochester, MN
SparkCures Verified Accurate, up-to-date information. Learn more
New York, NY
Charlotte, NC
Fairfax, VA
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