TAMPA, FLA. — For patients with blood cancers, such as non-Hodgkin’s lymphoma and multiple myeloma, chemotherapy can be a double-edged sword. On one hand, it is the standard course of treatment. However, it typically weakens patients’ immune systems to a point where their bodies can no longer effectively ward off other diseases or infections. Few patients would survive high-dose chemotherapy without an infusion of blood cells, a standard medical procedure called stem cell transplantation. Unfortunately, the optimal number of stem cells are not able to be collected in up to 65 percent of these patients.
Researchers at H. Lee Moffitt Cancer Center & Research Institute are now enrolling non Hodgkin’s lymphoma and multiple myeloma patients to determine if an investigational drug can dramatically increase the ability of patients to collect more stem cells.
“The success of transplantation is dependent on being able to collect enough stem cells, which can mean the difference between a patient being able to receive the transplant or not,” said Melissa Alsina, M.D., who is conducting the multiple myeloma study. “Patients who undergo transplantation where the proper number of stem cells cannot be collected from their blood stream can experience delayed recovery of their immune systems.”
The stem cell transplant will replace blood cells destroyed by high-dose chemotherapy. This procedure involves collecting the patient’s own stem cells from their blood stream, then infusing the cells back into the patient using a process similar to a blood transfusion. The strongest predictor of success in transplantation is the number of stems cells which can be collected from the patient.
A recently published study1 of this investigational drug, called AMD3100, found that 100 percent of patients receiving a combination of AMD3100 and the currently available drug, Granulocyte Colony Stimulating Factor (G-CSF), collected enough cells for transplant. This compared to 64 percent for patients using G-CSF alone. Also, 84 percent of patients in the combination group collected 50 percent more stem cells per day than patients in the G-CSF group.
“The purpose of these new studies is to gather additional data in a larger number of patients to gauge the safety and effectiveness of the drug in increasing stem cell collection,” said Teresa Field, M.D., who is conducting the study of non-Hodgkin’s lymphoma patients. “Stem cell transplantation is a standard procedure, but we’re trying to determine if it can be enhanced with AMD3100.”
The Moffitt Center is seeking 16 individuals with non-Hodgkins’s lymphoma and 16 with multiple myeloma for participation in the studies. Patients who are interested should call either Dr. Field’s office (non-Hodgkin’s lymphoma) at 813-979-7202 or Dr. Alsina’s office (multiple myeloma) at 813-972-8400.
Non-Hodgkin’s lymphoma is the fifth most common cancer and considered one of the fastest growing cancers (incidence) in the Western World. In the United States, the American Cancer Society projects approximately 55,000 new cases of non-Hodgkin’s lymphoma will be diagnosed this year. Non-Hodgkin’s lymphoma is frequently seen in older people (average age 65), but can manifest at any age. It is rapidly fatal if left untreated, but is curable.
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Multiple myeloma is incurable, but treatable. The estimated frequency of multiple myeloma in the United States is four to five new cases per 100,000 persons per year. Approximately 50,000 people in the United States currently are living with multiple myeloma, and the American Cancer Society estimates approximately 15,270 new cases of multiple myeloma were diagnosed in 2004.
AMD3100 is the first in a new class of agents found to induce the rapid release of stem cells into the blood system. AMD3100 currently is in clinical testing in North America and Europe as a potential new agent for stem cell production in cancer patients undergoing a stem cell transplant. It is not yet approved for commercial use. To date, 420 cancer patients have received AMD3100 in clinical studies, and safety data has been reported on 190 subjects.
AnorMED, the maker of AMD3100 and sponsor of the studies, is a biopharmaceutical company focused on the discovery, development, and commercialization of new therapeutic products in the areas of hematology, HIV, and oncology. The company has four products in clinical development and a research program focused on a novel class of drugs that target specific chemokine receptors known to be involved in a variety of diseases. Information on AnorMED is available on the company’s Web site, www.anormed.com.
In 2001, the National Cancer Institute awarded Moffitt the status of a Comprehensive Cancer Center in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country’s leading cancer centers, and it listed in the U.S. News & World Report as one of the top cancer hospitals in America. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.
1 Flomenberg, et al. Blood. 1 Sept 2005, Vol. 106.