title: Modified high-dose melphalan and autologous SCT for AL amyloidosis or high-risk myeloma: analysis of SWOG trial S0115.
abstract: We designed a trial using two sequential cycles of modified high-dose melphalan at 100 mg/m(2) and autologous SCT (mHDM/SCT) in AL amyloidosis (light-chain amyloidosis, AL), AL with myeloma (ALM) and host-based high-risk myeloma (hM) patients through SWOG-0115. The primary objective was to evaluate OS. From 2004 to 2010, 93 eligible patients were enrolled at 17 centers in the United States (59 with AL, 9 with ALM and 25 with hM). The median OS for patients with AL and ALM was 68 months and 47 months, respectively, and has not been reached for patients with hM. The median PFS for patients with AL and ALM was 38 months and 16 months, respectively, and has not been reached for patients with hM. The treatment-related mortality (TRM) was 12% (11/93) and was observed only in patients with AL after SCT. Grade 3 and higher non-hematologic adverse events were experienced by 81%, 67% and 57% of patients with AL, ALM and hM, respectively, during the first and second HDM/SCT. This experience demonstrates that with careful selection of patients and use of mHDM for SCT in patients with AL, ALM and hM, even in the setting of a multicenter study, OS can be improved with acceptable TRM and morbidity.
authors.affiliation: Boston Medical Center, Boston, MA, USA.
authors.forename: V
authors.initials: V
authors.lastname: Sanchorawala
authors.forename: A
authors.initials: A
authors.lastname: Hoering
authors.forename: D C
authors.initials: DC
authors.lastname: Seldin
authors.forename: K T
authors.initials: KT
authors.lastname: Finn
authors.forename: S A
authors.initials: SA
authors.lastname: Fennessey
authors.forename: R
authors.initials: R
authors.lastname: Sexton
authors.forename: B
authors.initials: B
authors.lastname: Mattar
authors.forename: H F
authors.initials: HF
authors.lastname: Safah
authors.forename: L A
authors.initials: LA
authors.lastname: Holmberg
authors.forename: R M
authors.initials: RM
authors.lastname: Dean
authors.forename: R Z
authors.initials: RZ
authors.lastname: Orlowski
authors.forename: B
authors.initials: B
authors.lastname: Barlogie
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000686:Amyloidosis / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D000075363:Immunoglobulin Light-chain Amyloidosis; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D011379:Prognosis; D013792:Thalidomide / Q000008:administration & dosage; D019172:Transplantation Conditioning / Q000379:methods*; D014182:Transplantation, Autologous / Q000379:methods* / Q000401:mortality
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D008558:Melphalan