title: Quality assessment of autografting by probability evaluation: model estimation by clinical end-points in newly diagnosed multiple myeloma patients.
abstract: BACKGROUND
  Pre-transplant clinical evaluation of autografting is an important step in predicting post-transplant support, complications and safety. Today, unfavorable outcomes such as early death or graft failure are rare, making them unsuitable for quality assessment of supportive autografting. However, end-points constructed from frequently occurring clinical events may estimate clinically relevant prognostic models.
  
  
  METHODS
  The present retrospective analysis was based on two consecutive clinical trials in the Nordic area including up to 640 newly diagnosed multiple myeloma patients.
  
  
  RESULTS
  In the model, the efficacy (time on antibiotics and use of transfusions) was influenced by pre-transplant variables, including sex, nationality, serum creatinine, hemoglobin, disease stage at diagnosis, response following induction therapy, length of priming and average graft CD34+ cell number per day of harvest. The toxicity end-point (time to blood cell recovery) was influenced by nationality, marrow plasma cell percentage, serum creatinine, M-component isotype, response to induction therapy, length of priming and graft CD34+ cell number. The safety (early disease recurrence or death) was influenced by serum creatinine, hemoglobin, treatment response and CD34+ cell number.
  
  
  CONCLUSIONS
  In conclusion, the model illustrates that intervention strategies in quality assessment of autografting may benefit from probability estimates of graded clinical end-points.
authors.affiliation: Department of Hematology, Herlev University Hospital, Herlev, Denmark.
authors.forename: O
authors.initials: O
authors.lastname: Roer
authors.forename: J
authors.initials: J
authors.lastname: Hammerstrøm
authors.forename: S
authors.initials: S
authors.lastname: Lenhoff
authors.forename: A K
authors.initials: AK
authors.lastname: Mylin
authors.forename: L M
authors.initials: LM
authors.lastname: Knudsen
authors.forename: T
authors.initials: T
authors.lastname: Rasmussen
authors.forename: H E
authors.initials: HE
authors.lastname: Johnsen
mesh_terms: D002986:Clinical Trials as Topic; D023381:Endpoint Determination; D006801:Humans; D008875:Middle Aged; D008954:Models, Biological; D009101:Multiple Myeloma / Q000175:diagnosis*; D011336:Probability; D011379:Prognosis; D012189:Retrospective Studies; D014182:Transplantation, Autologous / Q000009:adverse effects / Q000592:standards*; D016896:Treatment Outcome