Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT03091257
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
An Open-label, Pilot Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
The names of the study drugs involved in this study are:
* Trametinib
* Dabrafenib
Detailed Description:
This research study is a Pilot Study, which is the first time investigators are examining this study drug in this disease. "Investigational" means that the combination of drugs is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the drugs for your type of cancer.
The FDA has not approved Trametinib or Dabrafenib for your specific disease but they have been approved for other uses.
Some cancers have changes (mutations) in a gene called BRAF or other genes, called KRAS or NRAS. These three genes tell the body to make a protein called BRAF, KRAS, or NRAS, respectively, which 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 working and sending signals in cancer cells, and thereby may block the growth and spread of cancer cells in people with cancers with BRAF, KRAS, or NRAS gene mutations. Dabrafenib and trametinib have been used in the treatment for other cancers in other research studies, and information from those research studies suggest that these agents may help to kill multiple myeloma cells.
Dabrafenib and trametinib, which are investigated in this research study may or may not kill myeloma cells effectively. We would like to see if these drugs given alone or in combination safely and effectively kill these cancer cells.
The FDA has not approved Trametinib or Dabrafenib for your specific disease but they have been approved for other uses.
Some cancers have changes (mutations) in a gene called BRAF or other genes, called KRAS or NRAS. These three genes tell the body to make a protein called BRAF, KRAS, or NRAS, respectively, which 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 working and sending signals in cancer cells, and thereby may block the growth and spread of cancer cells in people with cancers with BRAF, KRAS, or NRAS gene mutations. Dabrafenib and trametinib have been used in the treatment for other cancers in other research studies, and information from those research studies suggest that these agents may help to kill multiple myeloma cells.
Dabrafenib and trametinib, which are investigated in this research study may or may not kill myeloma cells effectively. We would like to see if these drugs given alone or in combination safely and effectively kill these cancer cells.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: