For COVID-19 vaccine updates, please review our information guide. For patient eligibility and scheduling availability, please visit VaccineTogetherNY.org.

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

Clinical Trial Details

This research study is a pilot study, meaning it is the first-time investigators are examining the oral inhibitors Trametinib and Dabrafenib as a potential treatment for  multiple myeloma patients. The U.S. Food and Drug Administration (FDA) has not yet approved these drugs for multiple myeloma, but they have been approved for other uses.

Some cancers have changes (mutations) in the BRAF, KRAS or NRAS genes. These three genes produce proteins that are all involved in sending signals in cells that can lead to cell growth. Certain mutations in these three genes cause a change in these proteins that can increase the growth and spread of cancer cells.
   
Dabrafenib and trametinib work to prevent these altered proteins from sending signals in cancer cells, and thereby may block the growth and spread of cancer cells in cancers with BRAF, KRAS, or NRAS gene mutations. Dabrafenib and trametinib have been used in the treatment of different cancers in other research studies, and information from those research studies suggest that these agents may help to kill multiple myeloma cells.

Participants who are interested in this study will have their tumor tissue undergo genetic testing to detect for BRAF, KRAS, and NRAS gene mutations. As part of this test, the DNA sequence of genes other than BRAF, KRAS, or NRAS may be determined at the same time.

Not everyone who participates in this research study will receive the same drugs. The type and dose of the drug will depend on the type of mutation that was detected in your multiple myeloma tissue. The below summarizes what type of treatment will be received depending on the genetic mutation detected.

  • KRAS gene: trametinib taken orally once per day.
  • NRAS gene: trametinib taken orally once per day.
  • BRAF gene (V600): dabrafenib taken orally twice per day OR dabrafenib taken orally twice per day and trametinib taken orally once per day
  • BRAF gene (non-V600): dabrafenib taken orally twice per day and trametinib taken orally once per day

Each study treatment cycle lasts 4 weeks. Safety and tolerability will be assessed once a month through collecting labs and a physical examination. Some other procedures that participants will have to complete throughout the study include a  bone marrow biopsy and x-rays. Some of these procedures are part of your routine care for multiple myeloma.

Participants can continue to receive study treatment for as long as their disease does not get worse, experience serious side effects, and the study doctor feels it is in their best interest to continue to receive dabrafenib and/or trametinib.

Key Eligibility: 

Inclusion Criteria:

  • Diagnosis of multiple myeloma
  • Relapsed disease after at least 2 lines of therapy
  • Age 18 years or older at the time of signing the informed consent form.      
  • Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 4 months after the last dose of study treatment. 

Exclusion Criteria:

  • Participant had myocardial infarction within 6 months prior to enrollment, heart failure, uncontrolled angina, or severe uncontrolled ventricular arrhythmias
  • Any serious or unstable pre-existing medical conditions, psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures
  • A history of Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection 
  • Female participants who are pregnant or breast-feeding  

Detailed eligibility criteria will be discussed with the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2001021396

ClinicalTrials.gov:

NCT03091257

Sponsor:

Mass General 16-352

Status

Open to Enrollment

Age Group

Adult

Sponsor