Dabrafenib + Trametinib for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option for multiple myeloma, a type of blood cancer. Researchers are testing two drugs, Dabrafenib (a BRAF inhibitor) and Trametinib (a MEK inhibitor), to determine their effectiveness in treating patients with certain gene mutations. The study divides participants into three groups, each receiving either one or both drugs. It suits those who have experienced multiple myeloma relapse after at least two treatments and have specific gene mutations. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not clearly specify if you need to stop taking your current medications. However, it mentions that participants cannot use certain investigational agents or anti-cancer treatments close to the start of the trial. It's best to discuss your current medications with the trial team to get specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that dabrafenib and trametinib are usually well-tolerated. One study found that common side effects of dabrafenib included fever, tiredness, chills, and nausea, affecting 20% or more of patients. The tolerance for trametinib varied based on administration; continuous use proved more challenging, but dose adjustments helped.
The FDA has approved the combination of dabrafenib and trametinib for other conditions with BRAF V600E mutations, indicating a known safety profile. While the combination may cause side effects like fever and fatigue, past studies have demonstrated significant survival benefits for other diseases.
Since this trial is in the early stages, the safety of this treatment for multiple myeloma is still under investigation. However, existing evidence provides some reassurance about its safety in people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Dabrafenib and Trametinib for multiple myeloma because these drugs target specific genetic mutations in cancer cells, setting them apart from standard treatments like chemotherapy and immunotherapy. Dabrafenib specifically targets BRAF V600 mutations, while Trametinib acts on KRAS or NRAS mutations. This precision approach could lead to more effective treatments with potentially fewer side effects. Additionally, the combination of these drugs might overcome resistance that often develops with traditional therapies, offering hope for improved outcomes in patients with these specific mutations.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that the drugs dabrafenib and trametinib can effectively treat cancers with certain mutations. In this trial, participants may receive dabrafenib, which targets BRAF mutations and shows promise for some rare cancers. Others may receive trametinib, which targets MEK pathways involved in cancer cell growth. Some participants will receive a combination of dabrafenib and trametinib, as studies have found that using these drugs together can reduce the risk of cancer recurrence or spread. Although specific data on their effectiveness for multiple myeloma is not yet available, these drugs are being studied for their potential to help with this condition.12467
Who Is on the Research Team?
Noopur S Raje, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Dabrafenib and/or Trametinib based on genetic mutations
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dabrafenib
- Trametinib
Dabrafenib is already approved in European Union, United States, Canada, Japan for the following indications:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- 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
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Multiple Myeloma Research Consortium
Collaborator
Barbara Ann Karmanos Cancer Institute
Collaborator
Novartis
Industry Sponsor
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