Journal Article

Phase II trial of high-dose topotecan, melphalan and CY with autologous stem cell support for multiple myeloma

Champlin, R E, Giralt, S A, Hosing, C, Popat, U, Anderlini, P, Qureshi, S, Wang, M, Qazilbash, M H, Saliba, R M, Donato, M, Kazmi, S M A

2011

Overview

In spite of high-dose chemotherapy followed by autologous hematopoietic SCT multiple myeloma (MM) eventually recurs, highlighting the need for more effective treatment approaches. Patients received topotecan 3.5 mg/m 2 intravenously on days –6 to –2, melphalan 70 mg/m 2 intravenously on days –3 and –2 and CY 1 g/m 2 intravenously on days –6, –5 and –4. Overall response rate (ORR) consisting of complete response and partial response (CR+PR, PFS, OS and toxicity are reported. Between August 2002 to March 2004, 60 patients (34 men and 26 women) with a median age of 61 years (range 45–72) were enrolled. Forty-one patients were treated for consolidation of first remission, while 19 patients had relapsed/refractory disease. ORR was 85% (CR 12%, very good PR 43% and PR 30%). Median time to neutrophil (ANC>0.5 × 10 9 /L) and plt engraftment (>20 × 10 9 /L) was 10 (range 7–12 days) and 9 days (range 6–79 days), respectively. A majority of the common adverse events were grade 1–3 mucositis/stomatitis (65%), grade 1 or 2 nausea (59%) and grade 1 or 2 diarrhea (41%). Median PFS was 18.5 months and median OS has yet not been reached. In conclusion, topotecan, melphalan and CY is a safe and active conditioning regimen for auto hematopoietic SCT in MM. The ORR and PFS were comparable to high-dose melphalan.

• Publisher: Nature Publishing Group UK,Nature Publishing Group
• Subject: 631/154/109/1941 / 692/699/67/1990/804 / 692/700/565/545/576/1855 / Aged / Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Antineoplastic Combined Chemotherapy Protocols - toxicity / Autografts / Biological and medical sciences / Bone marrow, stem cells transplantation. Graft versus host reaction / Cell Biology / Chemotherapy / Cyclophosphamide - administration & dosage / Diarrhea / Disease-Free Survival / Female / Graft Survival / Hematology / Hematopoietic Stem Cell Transplantation - adverse effects / Hematopoietic Stem Cell Transplantation - methods / Humans / Immunodeficiencies. Immunoglobulinopathies / Immunoglobulinopathies / Immunopathology / Internal Medicine / Leukocytes (neutrophilic) / Male / Medical sciences / Medicine / Medicine & Public Health / Melphalan / Melphalan - administration & dosage / Middle Aged / Mucositis / Multiple myeloma / Multiple Myeloma - complications / Multiple Myeloma - therapy / Nausea / original-article / Patients / Public Health / Recurrence / Remission / Remission Induction / Stem cell transplantation / Stem Cells / Stomatitis / Topotecan / Topotecan - administration & dosage / Toxicity / Transfusions. Complications. Transfusion reactions. Cell and gene therapy / Transplantation, Autologous / Treatment Outcome