Myeloma-Developing Regimens Using Genomics (MyDRUG)

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT03732703
Trial Phases:	Phase I Phase II	Protocol IDs:	MyDRUG (MMRC-085) (primary) NCI-2019-00698
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Multiple Myeloma Research Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT03732703

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).

Objectives

The study will enroll 228 patients enrolled to one of eight 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:

1. Relapse within 3 years post autologous stem cell transplantation (ASCT) on
maintenance, or 18 months if unmaintained

2. Relapse within 18 months of initial non-ASCT based therapy

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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