"Preliminary results are encouraging as far as response. We can conclude that this conditioning regimen is associated with acceptable toxicity and with high myeloma effect."
Dr. Javier de la Rubia
To view the video full screen, click on the small button next to the volume control in the lower right hand corner. Toxicity and Early Response after Single Daily Dose of Intravenous Busulfan and Melphalan as Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma. Session Type: Publication Only
Margarita Blanes, Javier de la Rubia, Juan J. Lahuerta, Juan D. Gonzalez, Paz Ribas, Carlos Solano, Miguel A. Sanz Hematology Department, Hospital La Fe, Valencia, Spain; Hematology Department, Hospital 12 de Octubre, Madrid, Spain; Hematology Department, Hospital Insular, Las Palmas, Spain; Hematology Department, Hospital Dr. Peset, Valencia, Spain; Hematology Department, Hospital Clinico, Valencia, Spain
Introduction: Conditioning regimen with oral busulfan (BU) and melphalan (MEL) for patients with multiple myeloma (MM) undergoing autologous transplant (ASCT) has been associated with a high incidence of liver complications, especially severe sinusoidal occlusive syndrome (SOS). Material and methods: We conducted the current study to assess the toxicity profile and outcomes associated with ASCT after intravenous (iv) BU-based conditioning in 45 patients (24 M/21 F; median age 60 years, range 34-71) with MM. Front-line chemotherapy consisted of VBMCP/VBAD (31cases), VAD (8 cases), and other regimens (6 cases). At transplant, 8 patients were in complete response (2 with negative immunofixation) 24 in partial response, 13 with other responses (6 with minor response, 5 had progressive disease, 1 stable disease, and 1 patient no evaluated). Median interval from diagnosis to transplant was 11 months (range 5-80). Conditioning regimen consisted of iv BU (3.2 mg/kg in a single daily dose, days -5 to -3) and MEL (140 mg/m2, day -2). In 39 patients this was the first ASCT and the remaining 6 had relapsed after a previous ASCT conditioned with MEL-based regimens. Results: Median number of CD34+ cells administered was 2.9 x10^6/kg (range 1-5.8). Hematopoietic recovery was fast with median (range) time to 0.5 PMN and 20 platelets x10^9/L of 12 (11-46) and 13 (9-64) days, respectively. The toxicity profile was favourable. Particularly, no case of SOS, commonly seen with the oral BU, has been reported. Mucositis was the non-hematopoietic toxicity most frequently seen (42 cases). Other toxicities observed were uncommon (gastrointestinal toxicity, 6 cases, increase of liver enzymes, 3 cases and mild cardiac failure, 1 case). Fever was observed in 38 patients: fever of unknown origin in 21 cases, microbiologically documented infection in 13 cases and clinically documented infection in the remaining 4 cases. Only 2 patients (4%) died due to transplant-related toxicity (one patient to pneumonia, day 51; the other patient to sepsis to Acinetobacter baumani, day 54). With a median follow-up of 18 months, 41 patients had been evaluated for response: 19 are in complete response (9 with negative immunofixation), 16 in partial response, 2 with minor response, 2 had progressive disease, and 2 transplant-related deaths. The 18 months actuarial overall and progression-free survival rates are 953% and 7010%, respectively. Interestingly, in 19 patients significant improvement response was observed after transplant. Conclusions: These preliminary results show that iv BU-containing regimen for MM is associated with an acceptable toxicity profile and with a high anti-myeloma effect.
Abstract #4928 appears in Blood, Volume 110, issue 11, November 16, 2007
Keywords: Busulfan-melphalan|Autologous Peripheral Blood Stem Cell Tansplantation|Myeloma
Disclosure: No relevant conflicts of interest to declare.
Session Info: Publication Only