1. ¹Department of Hematology and Oncology, Tübingen, Germany
2. ²Department for Radiotherapy, Tübingen, Germany
3. ³Department of Radiotherapy, Göttingen, Germany
4. ⁴Department of Hematology and Oncology, Göttingen, Germany
5. ⁵Institute for Medical Information Processing, Tübingen, Germany
6. ⁶Department of Hematology, City-Hospital, München, Germany
7. ⁷Department of Hematology/Oncology, Homburg, Germany
8. ⁸Department of Hematology/Oncology, Hamburg, Germany
9. ⁹Department of Hematology/Oncology, Augsburg, Germany
10. ¹⁰Department of Hematology/Oncology, Hannover, Germany
11. ¹¹Department of Hematology/Oncology, Oldenburg, Germany
12. ¹²Department of Hematology/Oncology, Ulm, Germany
13. ¹³Fred-Hutchinson Cancer Research Center, Seattle, WA, USA

Correspondence: Hermann Einsele, Department of Haematology/Oncology, Eberhard-Karls-Universität Tübingen, Otfried-Müller-Strae 10, 72076 Tübingen, Germany

Received 10 December 2002; Accepted 8 April 2003.

Abstract

The overall survival of patients with advanced multiple myeloma (MM) undergoing high-dose chemotherapy and autologous stem cell transplantation (SCT) depends mainly on the quality of response. Thus, to improve the response rate, a new intensified high-dose chemoradiotherapy was evaluated in a phase I/II study. After induction chemotherapy, 89 patients (median age 51 years, range 32–60 years) with MM stage II/III received a conditioning regimen with total marrow irradiation (9 Gy), busulfan (12 mg/kg) and cyclophosphamide (120 mg/kg) followed by SCT. Regimen-related toxicity according to WHO criteria and response rates defined by EBMT/IBMTR were analyzed. The main toxicity was mucositis grade III/IV in 76%, and fever grade >I in 75% of patients. Three patients developed reversible veno-occlusive disease. Transplant-related mortality was 2%. Among patients with de novo and pretreated MM, a CR rate of 48 and 41%, respectively, was documented. With a median follow-up of 45 months, the actuarial median durations of event-free survival (EFS) and overall survival (OS) after transplant were 29 and 61 months for the whole group, 36 and 85 months for patients with de novo MM, respectively. Thus, administration of this intensified conditioning regimen was associated with tolerable toxicity, a high response rate and long EFS and OS.