8 THE NATIONAL MEDICAL JOURNAL OF INDIA VOL. 16, NO. 1, 2003 ABSTRACT Background.High dose chemotherapy followed by autolo- gous stem cell transplant is currently used for the treatment of patients with advanced multiple myeloma. However, there are no reports of the results of this treatment modality in Indian patients. Methods. Fifty patients with advanced multiple myeloma underwent treatment with high dose melphalan followed by autologous stem cell transplant (bone marrow: 7; peripheral blood stem cells: 43). The patients’ ages ranged from 26 to 65 years (median: 52 years) and 35 were men. All patients had receivedchemotherapyinitiallywithameanof9.4cycles(range: 1–36). Thirty patients had evidence of chemosensitive disease at the time of transplant. The mean interval from diagnosis to transplant was 17.5 months (range: 3–129 months) and the mediannumberofmononuclearcellsinfusedwas4.86×10 8 per kg (range: 2–10.48). Results.Post-transplant, 43 of 50 patients engrafted. The median number of days to engraftment (absolute neutrophil count >500/cmm) was 12 (range: 9–24) and to achieve platelet transfusion independence (>20 000/cmm) was 13 (range: 8–36). Seven patients died prior to engraftment. Grade III–IVoralmucositiswasthemajornon-haematologicaltoxicity. Excludingthe4patientswhohadcompleteresponsepriorto thetransplantandcontinuedinthesamestatuspost-transplant, 31/46 patients (67%) responded; complete response was achieved in 25 (54%) and partial response in 6 (13%). Patients with chemosensitive disease had higher rates of complete response; 20 of 26 patients with partial response at transplant achievedcompleteresponsecomparedto5of20patientswith persistent/refractory disease (p<0.01). Currently, 34 of 50 (68%) patients are alive, 17 (34%) disease-free, 6 with disease are on salvage therapy, 11 (22%) with positive monoclonal protein but asymptomatic are under observation. Nine (18%) patients have died; 8 due to progressive disease and 1 of an unrelatedcause.Themedianfollowupfortheentiregroupis26 months (range: 1–144 months). The Kaplan–Meier probability ofoverallandprogression-freesurvivalforthewholegroupat30 months is 62%±8.11% (SE) and 42%±9.54% (SE), respec- tively. A haemoglobin level £10 g/dl (p<0.003) affected the High dose chemotherapy followed by autologous haemopoietic stem cell transplant in multiple myeloma LALIT KUMAR, G. M. K. RAJU, K. GANESSAN, S. SHAWGI, H. MENON, J. WADHWA, A. SHARMA, RAJVEER SINGH, V. KOCHUPILLAI survivaladversely.Chemosensitivedisease(p<0.008)attrans- plantandcompleteresponsepost-transplant(p<0.0001)were associatedwithsignificantlylongersurvival. Conclusion.High dose melphalan followed by autologous stemcelltransplantationisaneffectivetreatmentforpatientswith advanced multiple myeloma and achievement of complete responseisassociatedwithimprovedsurvival. Natl Med J India 2003;16:16–21 INTRODUCTION Multiple myeloma (MM) is a malignant disease of B cell origin and is characterized by the presence of monoclonal plasma cells in the bone marrow. The disease is uniformly fatal with a median survival of 3–3.5 years. 1 Treatment with chemotherapy (melphalan and prednisolone) has a response rate of 40%–60% with a com- plete response (CR) in <10%. 2 Continuous infusion of vincristine and adriamycin daily for 4 days along with dexamethasone (VAD) or methyl prednisolone (VAMP) is associated with higher re- sponse rates (60%–80%) and CR in 10%–20% of patients. 3,4 During the past decade, treatment with high dose chemotherapy (HDCT) supported by autologous peripheral blood stem cell (PBSC) transplantation has become the standard therapy for advanced MM. This has resulted in improved response rates, and higher overall and event-free survival compared to conventional chemotherapy. 5–20 Though large data are available from North America and Europe, limited data are available from developing countries and none from India. We report our experience with 50 patients of MM treated with HDCT followed by autologous stem cell transplantation (ASCT). PATIENTS AND METHODS Between April 1990 and April 2002, 50 patients (35 men) with MM were treated with HDCT followed by ASCT; 43 of these had ASCT between October 1995 and April 2002. The median age of the patients was 52 years (range: 26–65 years). Table I shows the myeloma subtypes and stage of disease in these patients. All patients had initially received chemotherapy either with VAD alone (n=24) or VMCP (vincristine, melphalan, cyclophospha- mide and prednisolone) or MP (melphalan and prednisolone) or both (n=26). The mean number of chemotherapy cycles received was 9.4 (range: 1–36). Thirty patients (60%) had chemosensitive disease, 20 had stable or chemoresistant or refractory disease. Thirty-seven patients had also received radiotherapy. Sixteen (32%) patients had renal insufficiency (serum creatinine ³2 mg/dl) at the time of diagnosis. The mean interval from diagnosis to transplant was 17.5 months (range 3–129 months). Transplant protocol The initial evaluation included a detailed history, physical exami- Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110029, India LALIT KUMAR, G. M. K. RAJU, K. GANESSAN, S. SHAWGI, H. MENON, J. WADHWA, A. SHARMA, V. KOCHUPILLAI Department of Medical Oncology RAJVEER SINGH Department of Biostatistics Correspondence to LALIT KUMAR; lalitaiims@yahoo.com © The National Medical Journal of India 2003 Original Articles