title: Thalidomide-dexamethasone as induction therapy before autologous stem cell transplantation in patients with newly diagnosed multiple myeloma and renal insufficiency.
abstract: The aim of this study was to evaluate the efficacy and the toxicity of thalidomide-dexamethasone (Thal-Dex) as induction therapy before autologous peripheral blood stem cell (PBSC) transplantation in patients with newly diagnosed multiple myeloma (MM) with renal insufficiency. The study included 31 patients with a baseline creatinine clearance value <or=50 mL/min, 7 of whom required chronic hemodialysis. Patients received 4 months of Thal-Dex, followed by PBSC collection and subsequent transplantation. After induction, a partial response (PR) or greater was obtained in 23 patients (74%), including 8 (26%) who achieved a very good PR. Renal function improved more frequently in patients achieving a PR or greater (82%, vs 37% in patients achieving less than a PR; P = .04). Twenty-six patients underwent PBSC mobilization; in 17 of these patients (65%), >4 x 10(6) CD34(+) cells/kg were collected. Double autologous transplantation was performed in 15 patients, and a single autologous transplantation was performed in 7 patients. After a median of 32 months of follow-up, median event-free survival was 30 months, and median survival was not determined. According to our data, Thal-Dex is effective and safe in patients with newly diagnosed MM and renal insufficiency. Given the relationship between recovery of renal function and response to induction treatment, more intensive Thal + bortezomib regimens could be explored to rescue higher numbers of patients.
authors.affiliation: Institute of Hematology and Medical Oncology L. & A. Seràgnoli, Bologna University, Bologna, Italy. patrizia.tosi@unibo.it
authors.forename: Patrizia
authors.initials: P
authors.lastname: Tosi
authors.forename: Elena
authors.initials: E
authors.lastname: Zamagni
authors.forename: Paola
authors.initials: P
authors.lastname: Tacchetti
authors.forename: Michela
authors.initials: M
authors.lastname: Ceccolini
authors.forename: Giulia
authors.initials: G
authors.lastname: Perrone
authors.forename: Annamaria
authors.initials: A
authors.lastname: Brioli
authors.forename: Maria Caterina
authors.initials: MC
authors.lastname: Pallotti
authors.forename: Lucia
authors.initials: L
authors.lastname: Pantani
authors.forename: Alessandro
authors.initials: A
authors.lastname: Petrucci
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Michele
authors.initials: M
authors.lastname: Cavo
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods*; D012074:Remission Induction; D051437:Renal Insufficiency / Q000150:complications* / Q000209:etiology; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D014182:Transplantation, Autologous
chemical_list: D013792:Thalidomide; D003907:Dexamethasone