Dabrafenib + Trametinib for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Noopur S Raje, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Massachusetts General Hospital

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research study is studying a targeted therapy as a possible treatment for multiple myeloma. The names of the study drugs involved in this study are: * Trametinib * Dabrafenib

Research Team

Noopur S Raje, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with relapsed or refractory multiple myeloma, who have certain levels of monoclonal proteins in their blood or urine and have tried at least two other treatments. They should be relatively active (able to care for themselves) and not bedridden.

Inclusion Criteria

I am 18 years old or older.

My multiple myeloma can be measured by tests.

Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and agree to use adequate contraception

Exclusion Criteria

My multiple myeloma does not produce measurable proteins in blood or urine.

I am not taking any medications that are not allowed in the study.

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

Treatment Details

Interventions

• Dabrafenib (Kinase Inhibitor)
• Trametinib (Kinase Inhibitor)

Trial Overview The study is testing the effectiveness of two targeted therapy drugs, Trametinib and Dabrafenib, as potential treatments for multiple myeloma. It aims to see how well these drugs work on their own or together in treating this condition.

Participant Groups

Group I: Trametinib Experimental Treatment 1 Intervention

Determine if mutation in BRAF, KRAS, NRAS * KRAS or NRAS mutated * Treat cohort with Trametinib * Analysis * Treat cohort with Trametinib

Group II: Dabrafenib and Trametinib Experimental Treatment 2 Interventions

Determine if mutation in BRAF, KRAS, NRAS * BRAF V600 mutated, BRAF/KRAS mutated, or BRAF/NRAS mutated, or BRAF non-V600 mutated * Treat cohort with Dabrafenib and Trametinib * Analysis * Treat cohort with Dabrafenib and Trametinib

Group III: Dabrafenib Experimental Treatment 1 Intervention

Determine if mutation in BRAF, KRAS, NRAS * BRAF V600 mutated * Treat cohort with Dabrafenib * Analysis * Treat cohort with Dabrafenib

Dabrafenib is already approved in Canada, Japan for the following indications:

Approved in Canada as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation
• Adjuvant treatment of melanoma with a BRAF V600 mutation

Approved in Japan as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Multiple Myeloma Research Consortium

Collaborator

Trials

21

Recruited

1,200+

Barbara Ann Karmanos Cancer Institute

Collaborator

Trials

166

Recruited

9,300+

Dr. Boris C. Pasche

Barbara Ann Karmanos Cancer Institute

Chief Executive Officer since 2023

MD, PhD

Dr. Ann Schwartz

Barbara Ann Karmanos Cancer Institute

Chief Medical Officer since 2010

PhD in Epidemiology, University of Michigan

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania