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Network to Focus on Blood and Marrow Transplant ResearchA new research network, the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), plans to launch several new studies this fall, designed to answer important questions for transplant patients. Sponsored by the National Heart, Lung and Blood Institute and the National Cancer Institute, and coordinated by the International Bone Marrow Transplant Registry, the National Marrow Donor Program and the EMMES Corporation, the group hopes to identify transplant strategies that will reduce transplant-related complications and improve transplant outcomes. "This initiative involves the collaborative efforts of more than 50 transplant centers in the United States, offering the promise of answering important questions in BMT much more quickly than has been possible in the past," says Mary Horowitz MD of the International Bone Marrow Transplant Registry. The first research trial to open in November will compare two drugs-fluconazole and voriconazole-which are commonly used to prevent fungal infections in transplant patients. "Fungal infections are a serious problem after allogeneic transplantation, especially in the first year when patients' immune systems may be too weak to prevent their occurrence or allow recovery," explains Horowitz. "New drugs offer hope of better prevention and treatment but also may cause new problems from side effects. Only large clinical trials can determine whether using a new drug is really beneficial." A second study will compare several treatments currently available for patients with multiple myeloma to determine which, if any, is superior. Patients who do not have a matched related donor will undergo two autologous stem cell transplants (a transplant using their own blood stem cells). This procedure is sometimes called a tandem transplant. Half will receive follow-up chemotherapy, the other half will not. A third group will undergo an autologous stem cell transplant followed by a nonmyeloablative transplant using stem cells from a matched related donor. A nonmyeloablative transplant is similar to a standard stem cell transplant except that patients receive less intensive dosages of chemotherapy. The third study, scheduled to open in late November, will analyze a new trend in unrelated donor transplantation: using stem cells collected from the bloodstream (peripheral blood stem cells or PBSC) rather than bone marrow when transplanting patients. The study will examine whether the source of stem cells affects survival rates, recovery of bone marrow function, the incidence of graft-versus-host disease, relapse and/or quality of life. The study will also compare the effect of donating PBSC versus bone marrow on the donor's quality of life. A fourth study will address treatment options for patients with relapsed low-grade lymphoma. Patients will be randomized to receive either an autologous stem cell transplant or a nonmyeloablative transplant. Patients will be monitored for three years and survival rates will be compared. The number of patients to be enrolled in each study is large: 600 for the fungal infection trial, 500 for the multiple myeloma trial, 550 for the bone marrow vs. peripheral blood stem cell trial, and 360 for the low-grade lymphoma trial. The large number of patients is required in order for each trial to reach a statistically significant conclusion. Despite the large numbers, investigators expect to enroll the necessary patients in three years or less. "Through clinical trials focused on important issues in blood and marrow transplantation, BMT CTN hopes to provide knowledge that will improve outcomes for patients facing life-threatening diseases," says Jean Henslee-Downey MD, project officer of the National Heart, Lung and Blood Institute. Patients and physicians who are interested in learning more about the trials being conducted by BMT CTN can visit the web site-www.bmtctn.net-or phone Dr. Jean Henslee-Downey at 301-435-0065. Additional studies are being developed and will be posted on the web site as information becomes available.
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