Phase II Study Of Deacetylase Inhibitor For Multiple Myeloma Patients

Multiple Myeloma

Multiple Myeloma Research Consortium participates in a Phase II study to determine the efficacy of LBH589 for the treatment of patients with relapsed or refractory multiple myeloma.

LBH589 is an orally administered deacetylase inhibitor developed by Novartis Pharmaceuticals.

The MMRC is the only research model of its kind bringing together 13 leading academic institutions to accelerate the development of novel and combination treatments for multiple myeloma, an incurable cancer of the plasma cell. In addition to its most recent partnership with Novartis, the MMRC is facilitating several other clinical trials, including a Phase I study of NPI- 0052, a proteasome inhibitor, in collaboration with Nereus Pharmaceuticals, and a Phase I study of perifosine, lenalidomide (REVLIMID), and dexamethasone in collaboration with Keryx Biopharmaceuticals.

"Deacetylase inhibitors may represent a new treatment options for cancer patients and the MMRC is proud to work with Novartis to advance this important clinical program," said Kathy Giusti, Founder and Chief Executive Officer of the MMRC, as well as a myeloma patient. "This trial and the others the MMRC is facilitating demonstrate the importance of novel collaborations in bringing new treatments to patients."

Named ALPHA-MM, this trial is a single arm, open label, multi-center global study that will enroll 144 patients in the United States, Canada, and Europe. MMRC Member Institutions that will enroll patients are Dana-Farber Cancer Institute, City of Hope National Medical Center, Emory University, Hackensack University Medical Center, Mayo Clinic, H. Lee Moffitt Cancer Center & Research Institute, and Washington University.

This trial is open to patients with relapsed or refractory multiple myeloma who have received at least two lines of therapy, and whose disease progressed on their most recent therapy. Prior therapy must have included bortezomib (VELCADE) or lenalidomide.

LBH589 is part of a promising class of drugs called deacetylase inhibitors or HDAC inhibitors, which may play an important role in helping to slow or stop the growth of multiple myeloma cells. Preclinical laboratory data suggests that LBH589 has significant activity against multiple myeloma cells, including those that are resistant to conventional therapies.