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Report for Clinical Trial NCT03732703

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Myeloma-Developing Regimens Using Genomics (MyDRUG) (Genomics Guided Multi-arm Trial of Targeted Agents Alone or in Combination With a Backbone Regimen)

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).

NCT03732703 Relapsed Refractory Multiple Myeloma
MeSH:Multiple Myeloma Neoplasms, Plasma Cell
HPO:Multiple myeloma

6 Interventions

Name: Abemaciclib, dexamethasone, ixazomib, pomalidomide

Description: Patients with relapsed Multiple Myeloma will receive Abemaciclib and Dexamethasone for the first 2 cycles. Abemaciclib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Type: Drug
Group Labels: 1

Sub-Protocol A1

Name: Enasidenib, dexamethasone, ixazomib, pomalidomide

Description: Patients with relapsed Multiple Myeloma will receive Enasidenib and Dexamethasone for the first 2 cycles. Enasidenib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Type: Drug
Group Labels: 1

Sub-Protocol B1

Name: Cobimetinib, dexamethasone, ixazomib, pomalidomide

Description: Patients with relapsed Multiple Myeloma will receive Cobimetinib and Dexamethasone for the first 2 cycles. Cobimetinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Type: Drug
Group Labels: 1

Sub-Protocol C1

Name: Erdafitinib, dexamethasone, ixazomib, pomalidomide

Description: Patients with relapsed Multiple Myeloma will receive Erdafitinib and Dexamethasone for the first 2 cycles. Erdafitinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Type: Drug
Group Labels: 1

Sub-Protocol D1

Name: Venetoclax, dexamethasone, ixazomib, pomalidomide

Description: Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Type: Drug
Group Labels: 1

Sub-Protocol E1

Name: Daratumumab, dexamethasone, ixazomib, pomalidomide

Description: Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Type: Drug
Group Labels: 1

Sub-Protocol Y1


Primary Outcomes

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 years

Description: • 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 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

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 ---



HPO Nodes


HPO: