Clinical trial NCT03732703: 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)
Conditions: Relapsed Refractory Multiple Myeloma
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).
Interventions:
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.
name: Abemaciclib, dexamethasone, ixazomib, pomalidomide
other_name: abemaciclib: Verzenio, LY2835219
ixazomib: Ninlaro, MLN2238
pomalidomide: Pomalyst
type: Drug
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.
name: Enasidenib, dexamethasone, ixazomib, pomalidomide
other_name: enasidenib: AG221, IDHIFA
ixazomib: Ninlaro, MLN2238
pomalidomide: Pomalyst
type: Drug
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.
name: Cobimetinib, dexamethasone, ixazomib, pomalidomide
other_name: cobimetinib: Cotellic, GDC-0973, RG7420
ixazomib: Ninlaro, MLN2238
pomalidomide: Pomalyst
type: Drug
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.
name: Erdafitinib, dexamethasone, ixazomib, pomalidomide
other_name: erdafitinib: G-024, JNJ-42756493, JNJ-493
ixazomib: Ninlaro, MLN2238
pomalidomide: Pomalyst
type: Drug
description: Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
name: Venetoclax, dexamethasone, ixazomib, pomalidomide
other_name: ixazomib: Ninlaro, MLN2238
pomalidomide: Pomalyst
venetoclax: Venclexta: ABT-199
type: Drug
description: Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
name: Daratumumab, dexamethasone, ixazomib, pomalidomide
other_name: daratumumab: Darzalex
ixazomib: Ninlaro, MLN2238
pomalidomide: Pomalyst
type: Drug
description: Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
name: Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide
other_name: Belantamab mafodotin: BLENREP, GSK2857916
type: Drug
description: Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
name: Selinexor, dexamethasone, ixazomib, pomalidomide
other_name: Selinexor: XPOVIO
type: Drug
Study arms:
design_group_description: Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
design_group_title: Sub-Protocol A1
design_group_type: Experimental
design_group_description: Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
design_group_title: Sub-Protocol B1
design_group_type: Experimental
design_group_description: Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
design_group_title: Sub-Protocol C1
design_group_type: Experimental
design_group_description: Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
design_group_title: Sub-Protocol D1
design_group_type: Experimental
design_group_description: Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
design_group_title: Sub-Protocol E1
design_group_type: Experimental
design_group_description: Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)
design_group_title: Sub-Protocol Y1
design_group_type: Experimental
design_group_description: Patients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd)
design_group_title: Sub-Protocol Y2
design_group_type: Experimental
design_group_description: Patients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd)
design_group_title: Sub-Protocol Y3
design_group_type: Experimental
Sponsor: Multiple Myeloma Research Consortium
Collaborators: Genentech, Inc.
Takeda Pharmaceutical Co., Ltd.
Janssen LP
Karyopharm Therapeutics, Inc.
GSK Plc
Celgene Corp.
Eli Lilly & Co.
AbbVie, Inc.
Drug name mappings:
name: 可美替尼
lang: CN
name: Cobimetinib Fumarate
lang: EN
name: 甲磺酸恩西地平
lang: CN
name: Enasidenib Mesylate
lang: EN
name: 枸橼酸伊沙佐米
lang: CN
name: Ixazomib citrate
lang: EN
name: イキサゾミブクエン酸エステル
lang: JP
name: 达雷妥尤单抗
lang: CN
name: Daratumumab
lang: EN
name: ダラツムマブ（遺伝子組換え）
lang: JP
name: 玛贝兰妥单抗
lang: CN
name: Belantamab mafodotin
lang: EN
name: ベランタマブ マホドチン（遺伝子組換え）
lang: JP
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
lang: JP
name: 阿贝西利
lang: CN
name: Abemaciclib
lang: EN
name: アベマシクリブ
lang: JP
name: 厄达替尼
lang: CN
name: Erdafitinib
lang: EN
name: エルダフィチニブ
lang: JP
name: 泊马度胺
lang: CN
name: Pomalidomide
lang: EN
name: ポマリドミド
lang: JP
name: 塞利尼索
lang: CN
name: Selinexor
lang: EN
name: 地塞米松
lang: CN
name: Dexamethasone
lang: EN
name: デキサメタゾン
lang: JP