Clinical Trial: The MyDrug MMRF Study Recruiting for 228 Myeloma Patients
The MMRF announced the launch of a new clinical trial called MyDrug (Myeloma - Developing Regimens Using Genomics). The goal of the study is to match 228 patients with specific genetic myeloma features (like 11;14, 4;14 or other genetic features) with medications.
Patients who qualify for the study are those with greater than 30% cells mutated with the following mutations:
- Deletion 1p
- Translocation 4;14
- Translocation 11;14
- KRAS or NRAS mutation
- BRAF V600E mutation
- IHD2 mutation
Learn More About MyDrug
Each of these patient types will be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. It’s a great extension of the excellent work done on myeloma genomics as part of the MMRF’s CoMMpass study.
Genetic sequencing of the tumor is required for each participant. The study anticipates enrolling 228 patients to one of 6 treatment arms (38 patients per arm). The study is open to patients with relapsed or refractory myeloma who have:
- 1-3 lines of prior therapies
- Received both a proteasome inhibitor like Velcade and an immunomodulatory drug like Revlimid
- Had early relapse after initial treatment (within 3 years of transplant with maintenance or 18 months if without maintenance) OR (relapse within 18 months of initial treatment with no transplant)
Del 1 patients (CDKN2C is the affected gene)
These 38 patients will receive Abemaciclib and Dexamethasone for the first 2 cycles. Abemaciclib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Abemaciclib is a CDK inhibitor being used in breast cancer.
IDH2 mutation patients
These 38 patients will receive Enasidenib and dexamethasone initially for 2 cycles and then Enasidenib, dex, Ixazomib and pomalidomide from cycle 3 forward. Enasidenib is an IDH2 inhibitor already being used in acute myeloid leukemia.
RAF/RAS mutation patients
These 38 patients will receive Cobimetinib and Dexamethasone for the first 2 cycles. Cobimetinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Cobimetinib is a MEK kinase inhibitor.
Translocation 4;14 patients (FGFR3 is the affected gene)
These 38 patients will receive Erdafitinib and Dexamethasone for the first 2 cycles. Erdafitinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Erdafitinib is an FGFR inhibitor.
Translocation 11;14 patients (CCND1 is the affected gene)
These 38 patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Venetoclax is well known to be useful for 11;14 patients
Patients with non-actionable genetic mutations (any other mutation found not on the above list)
These 38 patients will receive daratumumab, ixazomib, pomalidomide and dexamethasone every cycle.
"We are excited to see the results of this type of study, especially using new drug-specific inhibitors currently being used in other cancers." said Jenny Ahlstrom, Founder of the Myeloma Crowd.
"The MyDrug study puts a spotlight on the need to understand your myeloma genetics," said Brian McMahon, Founder of SparkCures.
As we are learning in myeloma, not all myeloma is the same. The goal of precision and personalized medicine is to find personally relevant treatments that will have the biggest impact on your myeloma. In order to do this, you need to understand your myeloma genetics. Myeloma genetic information is the genetics of the myeloma cells, not your personal DNA. Myeloma genetics are found on bone marrow biopsy tests such as the FISH test, the Gene Expression Profile (GEP) and now the Next Generation Sequencing (NGS) tests. It is best if these tests are run at diagnosis and then again at relapse, so you can see how your myeloma is changing over time (because it can).
What Can Myeloma Patients Do Today?
What can patients do today to find the most personally optimal therapies? Because studies can take several years to identify outcome data, the Myeloma Crowd created HealthTree, a living patient community, to match patients with treatment options and clinical trials they could consider today. Today, over 2,200 patients (and growing) are sharing their myeloma story to help researchers come to faster conclusions.
If you have had myeloma genetic tests run already, then add your myeloma genetic information inside HealthTree. In HealthTree, patients share their myeloma genetic features, demographics, prior therapies and outcomes, fitness status and health history information to identify patterns of treatment and to find optimal courses of care. Which patients tend to relapse more quickly after transplant? Which induction therapies are the most effective for specific genetic features? How long of maintenance therapy should we consider? These are just a few of the answers we expect to share with patients and researchers from HealthTree.
Patients are joining HealthTree today regardless of their myeloma genetics to share their myeloma story and experience with thousands of other myeloma patients. Our list of reports is growing over time.
Patients using HealthTree can obtain benefit from this community of myeloma friends today by seeing treatment outcomes they can qualify for and clinical trials they can join.
Because myeloma is not cured yet and is so different in each patient, we applaud any and all projects to identify more personalized treatments in myeloma.