Myeloma-Developing Regimens Using Genomics MYDRUG

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

Additional Trial Information

Phase 1/2

Enrollment: 228 patients (estimated)

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Published Results

The Mydrug Platform Trial: Efficacy and Safety of Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone in Patients with Functionally High-Risk Multiple Myeloma

December 10, 2022

Thirty-eight patients were enrolled to the Y1 daratumumab arm with a median (range) age of 63 (46-79) years, with 16 (42.1%) patients of ages 65-74 and 2 (5.3%) patients ≥75 years. Thirteen (34.2%) patients were female, and 8 (21.1%) patients were Black or African American. The ORR for patients receiving daratumumab plus IPd was 92.1%, and 19 (50%) patients had a very good partial response. Thirty-seven (97.4%) patients experienced treatment-related AEs, 35 (92.1%) of which were related to daratumumab. Among patients receiving treatment, 22 (57.9%) experienced a serious AE; 3 (7.9%) experienced an AE leading to discontinuation; and 2 (5.3%) had fatal AEs.

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Ohio

The Ohio State University Comprehensive Cancer Center The James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting
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