Norwalk, September 25, 2014 –The Multiple Myeloma Research Consortium (MMRC) today announced that it has openedsix new clinical trials in 2014, and is on track to open more multiple myeloma clinical trials during 2014 than any other year since the Consortium was founded in 2004. These six new trials represent some of the most promising and brand new treatments in development today.
“Together, with our committed and world-class partners, we have opened six incredibly exciting new trials for multiple myeloma patients who are running out of treatment options,” said Fiona An, M.D., Senior Vice President of ClinicalResearch for the MMRF and MMRC. “We have such a robust pipeline of promising investigational agents – from monoclonal antibodies to first in class novel therapy to all oral regimens – and we are confident that they can prove to have a significant impact for many of our patients.”
These breakthrough MMRC Clinical Trials may provide hope for relapsed patients who may have few options left and have not responded to previous treatments:
• Phase I, Multicenter, Open-Label, Dose-Escalation Combination Study of Marizomib, Pomalidomide, and Low-Dose Dexamethasone (PMD) in subjects with relapsed or refractory multiple myeloma. Marizomib is a novel proteasome inhibitor from Triphase – in the same class as Velcade (bortezomib) and Kyprolis (carfilzomib) – that has been studied in Phase I single agent trial in the MMRC. Investigators believe that it can work in patients who are resistant to other proteasome inhibitors.
• Multicenter, Phase I/IIb Study of Ibrutinib, in combination with Kyprolis in subjects with relapsed or relapsed and refractory multiple myeloma. Ibrutinib blocks a protein called Bruton’s tyrosine kinase (BTK), and is an oral drug already approved by FDA for patients with Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy, and for all patients with Deletion 17 p CLL.
• Phase I Study of the combination of a Selective Inhibitor of Nuclear Export (SINE), Selinexor (KPT-330), with Kyprolis and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Selinexor is the first in a new class of drugs to be tested in multiple myeloma, and the MMRF played a key role in prioritizing multiple myeloma as an early indication by providing Karyopharm, the manufacturer, with a Biotech Investment Award (BIA) in 2010.
• Phase I Study of SAR650984 for the treatment of relapsed or refractory multiple myeloma. SAR650984 is an anti-CD 38 monoclonal antibody therapy that was previously studied in combination with Revlimid and dexamethasone in the MMRC. Early results show that this treatment can be effective – even as a single agent – in patients who have failed all other options.
• A Phase I/II trial of Ixazomib (MLN9708) in combination with Pomalyst (pomalidomide) and dexamethasone for relapsed or relapsed refractory multiple myeloma. Previous Phase I and II research with ixazomib in combination with lenalidomide and dexamethasone in newly diagnosed patients found high response rates and increased depth of response. Ixazomib is a once-a-week pill that has the potential to enable the first all-oral proteasome-based treatment regimen.
• Phase I, Open Label, Dose-Escalation first in man study of CB-5083, the first p97 inhibitor to enter clinical trials. Several MMRC member institutions worked closely with manufacturer Cleave Biosciences on the preclinical work, which suggested activity in multiple myeloma. CB-5083 targets a novel protein, p97 that is involved in various aspects of protein homeostasis and the proteasome pathway and inhibits this pathway at a novel intervention point compared to the proteasome inhibitors, Velcade and Kyprolis. This is a mechanistically distinct way of inhibiting this critical pathway and may provide benefit for patients who are relapsed and refractory.
Sagar Lonial, MD, Vice Chairman of Clinical Affairs Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University and Chairman of the MMRC Steering Committee and the Project Review Committee, praised the MMRC for its diligent work this year and what it is accomplishing in filling its pipeline with new lifesaving drugs.
“The ability of our myeloma focused clinicians to rapidly move laboratory data into real world clinical trials is a real strength of the consortium. New treatments and combinations represent the future of how we will treat myeloma. The strides made just this year will help our patients in their goals to control and ultimately cure the disease,” Dr. Lonial said.
About the Multiple Myeloma Research Foundation (MMRF)
The Multiple Myeloma Research Foundation (MMRF) was established in 1998 as a 501(c)(3) non-profit organization by twin sisters Karen Andrews and Kathy Giusti, soon after Kathy's diagnosis with multiple myeloma. The mission of the MMRF is to relentlessly pursue innovative means that accelerate the development of next-generation multiple myeloma treatments to extend the lives of patients and lead to a cure. As the world's number-one private funder of multiple myeloma research, the MMRF has raised $250 million since its inception and directs nearly 90% of total budget to research and related programming. As a result, the MMRF has been awarded Charity Navigator’s coveted four-star rating for 11 consecutive years, the highest designation for outstanding fiscal responsibility and exceptional efficiency. For more information about the MMRF, please visit: www.themmrf.org.
About the Multiple Myeloma Research Consortium (MMRC)
The Multiple Myeloma Research Consortium (MMRC) is a 509(a)(3) non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is led from MMRC offices in Norwalk, Conn., and comprises 16 member institutions: Barbara Ann Karmanos Cancer Institute, Baylor Charles A. Sammons Cancer Center at Dallas, City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the John Theurer Cancer Center at Hackensack University Medical Center, Mayo Clinic, Mount Sinai School of Medicine, Ohio State University, Sarah Cannon Research Institute, University Health Network (Princess Margaret Hospital), University of California-San Francisco, University of Chicago, University of Michigan, Virginia Cancer Specialists, and Washington University in St. Louis. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank. For more information, please visit www.themmrc.org.
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