title: Post-transplant consolidation therapy using thalidomide alone for the patients with multiple myeloma: a feasibility study in Japanese population.
abstract: In order to test for improved survival following autologous transplantation (ASCT), we conducted a prospective clinical trial of post-ASCT thalidomide therapy in Japanese patients with multiple myeloma (MM). Twenty-five newly diagnosed patients received double or single ASCT with high-dose melphalan (200 mg/m(2)). Two months after stem cell infusion, if the patients failed to achieve a near-complete response, thalidomide was administered at 200 mg/day until disease progression or occurrence of intolerable adverse events. Seventeen patients were in partial response or minimal response after ASCT and received thalidomide alone. Their median progression-free survival (PFS) from ASCT was 17.4 months, and the median overall survival (OS) was 42.9 months. Some patients with normal karyotype experienced durable disease stabilization for over 5 years. Five patients who exhibited high-risk chromosomal changes such as t(4;14) or deletion of chromosome 13 or 17 showed very short PFS and OS compared with those who did not. Observed grade 3 or 4 toxicities included infection in three patients, hematological toxicities in three, and gastrointestinal toxicities in two, but there was no grade 3 or higher peripheral neuropathy, probably due to appropriate dose modifications. This long-term prospective study is the first to demonstrate the feasibility of post-ASCT thalidomide therapy in Japanese patients with MM.
authors.affiliation: Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Tomoki
authors.initials: T
authors.lastname: Ueda
authors.forename: Rioko
authors.initials: R
authors.lastname: Iino
authors.forename: Kenji
authors.initials: K
authors.lastname: Yokoyama
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Okamoto
authors.forename: Keiko
authors.initials: K
authors.lastname: Asakura
authors.forename: Yuiko
authors.initials: Y
authors.lastname: Tsukada
authors.forename: Jo
authors.initials: J
authors.lastname: Ishizawa
authors.forename: Eri
authors.initials: E
authors.lastname: Matsuki
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ikeda
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Hattori
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D060830:Consolidation Chemotherapy; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide