title: Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant.
abstract: We report a multicenter, randomized phase II trial conducted to assess the tolerability of combined thalidomide and prednisone maintenance in multiple myeloma. Eligibility required administration of melphalan (200 mg/m2) with blood stem cell support within 1 year of treatment onset and initiation of maintenance within 60 to 100 days after stem cell infusion. All patients received 50 mg of prednisone by mouth on alternate days and thalidomide at a starting dose of either 200 or 400 mg daily by mouth. The primary end point was the incidence of dropout or dose reduction due to treatment toxicity within 6 months. Sixty-seven patients were enrolled. Median follow-up is 36.8 months. The primary end point was reached by 31% of patients on the 200 mg of thalidomide arm and 64% of patients on the 400 mg of thalidomide arm. Allowing for dose reduction, 76% of patients assigned to the 200 mg of thalidomide arm and 41% of patients assigned to the 400 mg of thalidomide arm remained on any maintenance therapy 18 months after registration. Eighty-eight percent of all patients dose-reduced thalidomide and 72% of all patients dose-reduced prednisone within 2 years of beginning maintenance. The median progression-free survival post-transplant is 32.3 months, or 42.2 months from diagnosis. Only the 200 mg of thalidomide arm of this trial met our definition of a tolerable maintenance therapy, defined as no dose reductions or discontinuation due to toxicity in at least 65% of patients for a minimum of 6 months, thus establishing a dosing schedule for phase III trials.
authors.affiliation: Princess Margaret Hospital, Toronto, Ontario, Canada. kstewart@uhnres.utoronto.ca
authors.forename: A Keith
authors.initials: AK
authors.lastname: Stewart
authors.forename: Christine I
authors.initials: CI
authors.lastname: Chen
authors.forename: Kang
authors.initials: K
authors.lastname: Howson-Jan
authors.forename: Darrell
authors.initials: D
authors.lastname: White
authors.forename: Jean
authors.initials: J
authors.lastname: Roy
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Kovacs
authors.forename: Chaim
authors.initials: C
authors.lastname: Shustik
authors.forename: Anna
authors.initials: A
authors.lastname: Sadura
authors.forename: Lois
authors.initials: L
authors.lastname: Shepherd
authors.forename: Keyue
authors.initials: K
authors.lastname: Ding
authors.forename: Ralph M
authors.initials: RM
authors.lastname: Meyer
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Belch
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D011241:Prednisone / Q000008:administration & dosage; D033581:Stem Cell Transplantation; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D011241:Prednisone