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Protocol # 19-719

Status

Recruiting

Description

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).

Condition

  • Relapsed Refractory Multiple Myeloma

Interventions

  • Abemaciclib, dexamethasone, ixazomib, pomalidomide
  • Enasidenib, dexamethasone, ixazomib, pomalidomide
  • Cobimetinib, dexamethasone, ixazomib, pomalidomide
  • Erdafitinib, dexamethasone, ixazomib, pomalidomide
  • Venetoclax, dexamethasone, ixazomib, pomalidomide
  • Daratumumab, dexamethasone, ixazomib, pomalidomide
  • Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide
  • Selinexor, dexamethasone, ixazomib, pomalidomide

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall Response Rate - Actionable Genetic Alteration
  • Overall Response Rate - Non-Actionable Genetic Alteration

Enrollment

228

Study Start Date

April 1, 2019

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Multiple Myeloma Research Consortium

Source

Multiple Myeloma Research Consortium

Official title

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

Clinicaltrials.gov Identifier

NCT03732703

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.