A Phase II Study of Dabrafenib and/or Trametinib in Patients with Recurrent or Persistent Multiple Myeloma

Full Title

An Open-Label, Pilot Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the drugs dabrafenib and trametinib given individually or in combination in patients with recurrent or persistent multiple myeloma containing mutations in genes called BRAF, KRAS, or NRAS. Some mutations in these three genes cause a change in proteins that can increase the growth and spread of cancer cells.

Dabrafenib and trametinib prevent altered BRAF, KRAS, and NRAS proteins from sending signals in cancer cells, thereby blocking the growth and spread of cancer cells in people whose cancers have mutations in the genes that make these proteins. Dabrafenib and trametinib are used to treat some forms of melanoma and lung cancer; their use in this study is considered investigational.

Patients in this study will receive trametinib alone, dabrafenib alone, or both medications together, depending on which genetic mutation(s) they have. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma that came back or continued to grow despite at least two regimens of treatment and contains a mutation in the BRAF, KRAS, or NRAS gene.
  • At least 2-3 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Malin Hultcrantz at 212-639-7986.

Protocol

18-274

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators