Dabrafenib + Trametinib for Multiple Myeloma
Palo Alto (17 mi)Overseen byNoopur 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
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.Treatment Details
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.
3Treatment groups
Experimental Treatment
Group I: TrametinibExperimental Treatment1 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 TrametinibExperimental Treatment2 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: DabrafenibExperimental Treatment1 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 European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Tafinlar for:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
🇺🇸 Approved in United States as Tafinlar for:
- Unresectable or metastatic melanoma with a BRAF V600E mutation
- Adjuvant treatment of melanoma with a BRAF V600E or V600K mutation
- Metastatic non-small cell lung cancer with a BRAF V600E mutation
🇨🇦 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Karmanos Cancer InstituteDetroit, MI
Massachusetts General HospitalBoston, MA
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
Multiple Myeloma Research ConsortiumCollaborator
Barbara Ann Karmanos Cancer InstituteCollaborator
NovartisIndustry Sponsor