NewYork-Presbyterian/Weill Cornell Multiple Myeloma Program Begins Clinical Trial of Promising New Chemotherapy Cocktail with Revlimid
Only Medical Center to Enroll Patients in New Research Study
Feb 2, 2005
The Center of Excellence for Lymphoma and Myeloma at NewYork-Presbyterian Hospital/Weill Cornell Medical Center is the only medical center in the nation to currently offer a chemotherapy cocktail with the next-generation immuno-modulatory research drug Revlimid™ (lenalidomide), as part of a clinical trial for patients with newly diagnosed multiple myeloma. Results of the single-center Phase II clinical trial are anticipated to show improved complete remission rate and response time, and decreased toxicity compared to the standard treatment.
The drug cocktail is known as BiRD, an acronym for its component parts: Biaxin® (clarithromycin, an antibiotic), Revlimid, and dexamethasone (Decadron®, a steroid). It is an induction therapy, the first step toward shrinking the cancer and evaluating patient response to the potential treatment.
Factors that point to the success of BiRD are two-fold. Preliminary results from a separate ongoing Phase II study of a similar cocktail known as BLTD (Biaxin, thalidomide, and dexamethasone) demonstrated a 93 percent response rate and 13 percent complete remission (CR) rate. (By comparison, the standard of care, dexamethasone alone, has a response rate of about only 50 percent.) Secondly, recent studies show that Revlimid is 1,000 times more potent than thalidomide (the precursor to Revlimid, also an immunomodulatory drug) without many of thalidomide's debilitating side effects. BiRD substitutes Revlimid for thalidomide.
"Revlimid is an exciting new drug that we fully anticipate will demonstrate a very impressive complete remission rate, thereby allowing patients to achieve long-term survival," said Dr. Ruben Niesvizky, director of NewYork-Presbyterian/Weill Cornell's Multiple Myeloma Program. "This therapy offers significant hope to approximately 15,000 Americans newly diagnosed with multiple myeloma every year."
Beyond safety and efficacy, the clinical trial is designed to explore the pharmacokinetics of the BiRD cocktail, particularly the anti-angiogenic effects of Revlimid (i.e. its anti-blood-vessel formation property); the synergistic effect of dexamethasone and Biaxin (the antibiotic boosts the effectiveness of the steroid), and their effect on Revlimid; and the drugs' absorption rates.
A separate recently completed study (Phase III, multicenter) for relapsed and refractory multiple myeloma patients compared a cocktail of dexamethasone and Revlimid to dexamethasone and placebo. For patients who did not respond, a second rollover study offered them Revlimid alone. Of all participating centers, NewYork-Presbyterian/Weill Cornell's Multiple Myeloma Program had the greatest number of enrolled patients for these two studies.
In addition to Dr. Ruben Niesvizky, study investigators include Drs. Selina Chen-Kiang, Hearn Cho, Morton Coleman, Richard Furman, John Leonard, Roger Pearse, Shahin Rafii, Michael Schuster, and Tsiporah Shore all of NewYork-Presbyterian/Weill Cornell.
Multiple myeloma is a blood cancer that causes white blood cells to become malignant and attack the body's bones, resulting in painful fractures, kidney failure, and death. The disease affects an estimated 40,000 Americans. From 1973 to 1999, the U.S. has seen a 35 percent increase in multiple-myeloma deaths; these numbers are rising for reasons that are not understood.
The Multiple Myeloma Program at NewYork-Presbyterian/Weill Cornell, one of the three largest such centers in the U.S., takes an aggressive and multidisciplinary approach offering programs for transplants, vaccine development and drugs, as well as clinical research trials for all stages of the disease. The Program's clinical research is funded, in part, by a $7.5-million Specialized Center of Research (SCOR) grant from the Leukemia and Lymphoma Society. The Myeloma Program is also enrolling other investigational drug therapies.
Dr. Ruben Niesvizky is also assistant professor of medicine at Weill Cornell Medical College and assistant attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Along with Dr. Niesvizky, Drs. Selina Chen-Kiang, Roger Pearse, Morton Coleman, and Michael Schuster conduct research and treat patients at the Multiple Myeloma Program.
The Celgene Corporation of Warren, NJ, which manufactures Revlimid and thalidomide, is funding the current BiRD study.
Patients seeking further information may contact NewYork-Presbyterian/Weill Cornell's Multiple Myeloma Program by visiting www.myelomacenter.org or calling (212) 746-3964.