Myeloma-Developing Regimens Using Genomics (MyDRUG)

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).

Conditions

• Relapsed Refractory Multiple Myeloma

Interventions

DRUG

Abemaciclib, dexamethasone, ixazomib, pomalidomide

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.

DRUG

Enasidenib, dexamethasone, ixazomib, pomalidomide

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.

DRUG

Cobimetinib, dexamethasone, ixazomib, pomalidomide

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.

DRUG

Erdafitinib, dexamethasone, ixazomib, pomalidomide

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.

DRUG

Venetoclax, dexamethasone, ixazomib, pomalidomide

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.

DRUG

Daratumumab, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

DRUG

Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

DRUG

Selinexor, dexamethasone, ixazomib, pomalidomide

Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Celgene Corporation

  collaborator INDUSTRY

• Eli Lilly and Company

  collaborator INDUSTRY

• Genentech, Inc.

  collaborator INDUSTRY

• Janssen, LP

  collaborator INDUSTRY

• Takeda

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Karyopharm Therapeutics Inc

  collaborator INDUSTRY

• Multiple Myeloma Research Consortium

  lead NETWORK

Principal Investigators

• Hearn J Cho, M.D., Ph.D. · Multiple Myeloma Research Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2024-12-31

Completion

2024-12-31

FDA Drug

Yes

Countries

• United States

Study Locations