title: Combination therapy with thalidomide and dexamethasone in patients with newly diagnosed multiple myeloma not undergoing upfront autologous stem cell transplantation: a phase II trial.
abstract: OBJECTIVE
  Thalidomide plus dexamethasone (Thal/Dex) has emerged as an effective alternative to vincristine, doxorubicin and dexamethasone as a pre-transplant induction therapy for newly diagnosed multiple myeloma. However, many patients treated initially with Thal/Dex do not proceed to autologous stem cell transplantation (ASCT) and the time to progression and other outcome measures with Thal/Dex as primary therapy for multiple myeloma are not known. We present the first data on the outcome of patients with newly diagnosed multiple myeloma treated with Thal/Dex who did not undergo upfront ASCT.
  
  
  METHODS
  We identified 21 patients with newly diagnosed multiple myeloma treated with Thal/Dex on a phase II clinical trial who did not undergo ASCT due to age, comorbidity or the patient's refusal. Patients received thalidomide at a dose of 200 mg/day orally and dexamethasone 40 mg daily on days 1-4, 9-12, 17-20 (odd months) and days 1-4 (even months). Cycles were repeated every 28 days.
  
  
  RESULTS
  The median age was 66 years (range 36-78). The median duration of follow-up was 21 months (range 1-52). One (5%) patient achieved a complete response, and 9 (43%) had a partial response, so the overall response rate was 48%. Of the remaining patients, 7 (33.3%) had stable disease, one patient did not respond, and three died while on therapy prior to response assessment. The median overall survival and time to progression were 21 months and 18 months, respectively.
  
  
  CONCLUSIONS
  The median time to disease progression in patients with multiple myeloma who receive initial therapy with Thal/Dex and who do not undergo ASCT is 18 months.
authors.affiliation: Division of Hematology, Department of Internal Medicine, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA.
authors.forename: David
authors.initials: D
authors.lastname: Dingli
authors.forename: S Vincent
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: Grzegorz S
authors.initials: GS
authors.lastname: Nowakowski
authors.forename: Morie A
authors.initials: MA
authors.lastname: Gertz
authors.forename: Angela
authors.initials: A
authors.lastname: Dispenzieri
authors.forename: Martha Q
authors.initials: MQ
authors.lastname: Lacy
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hayman
authors.forename: Rafael
authors.initials: R
authors.lastname: Fonseca
authors.forename: John A
authors.initials: JA
authors.lastname: Lust
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kyle
authors.forename: Philip R
authors.initials: PR
authors.lastname: Greipp
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019090:Case Management; D017322:Clinical Trials, Phase II as Topic; D015331:Cohort Studies; D003248:Constipation / Q000139:chemically induced; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004487:Edema / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D010292:Paresthesia / Q000139:chemically induced; D012074:Remission Induction; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone