title: A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial.
abstract: We conducted a randomized, controlled trial comparing thalidomide-prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival,progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide-prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P < .0001) and more frequent venous thromboembolism (7.3% vs none; P = .0004). Median survival after first disease recurrence was 27.7 months with thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomide-prednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit.
authors.affiliation: Division of Hematology-Oncology, Mayo Clinic in Arizona, 13400 East Shea Blvd, Scottsdale, AZ 85259, USA. stewart.keith@mayo.edu
authors.forename: A Keith
authors.initials: AK
authors.lastname: Stewart
authors.forename: Suzanne
authors.initials: S
authors.lastname: Trudel
authors.forename: Nizar J
authors.initials: NJ
authors.lastname: Bahlis
authors.forename: Darrell
authors.initials: D
authors.lastname: White
authors.forename: Waleed
authors.initials: W
authors.lastname: Sabry
authors.forename: Andrew
authors.initials: A
authors.lastname: Belch
authors.forename: Tony
authors.initials: T
authors.lastname: Reiman
authors.forename: Jean
authors.initials: J
authors.lastname: Roy
authors.forename: Chaim
authors.initials: C
authors.lastname: Shustik
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Kovacs
authors.forename: Morel
authors.initials: M
authors.lastname: Rubinger
authors.forename: Guy
authors.initials: G
authors.lastname: Cantin
authors.forename: Kevin
authors.initials: K
authors.lastname: Song
authors.forename: Kirsty A
authors.initials: KA
authors.lastname: Tompkins
authors.forename: Deb C
authors.initials: DC
authors.lastname: Marcellus
authors.forename: Martha Q
authors.initials: MQ
authors.lastname: Lacy
authors.forename: Jonathan
authors.initials: J
authors.lastname: Sussman
authors.forename: Donna
authors.initials: D
authors.lastname: Reece
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.forename: Erica L
authors.initials: EL
authors.lastname: Harnett
authors.forename: Lois
authors.initials: L
authors.lastname: Shepherd
authors.forename: Judy-Anne W
authors.initials: JA
authors.lastname: Chapman
authors.forename: Ralph M
authors.initials: RM
authors.lastname: Meyer
mesh_terms: D000047:Academies and Institutes; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada / Q000453:epidemiology; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008495:Medical Oncology / Q000458:organization & administration; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D011241:Prednisone