title: A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome.
abstract: BACKGROUND
  The median survival of patients with myeloma after conventional chemotherapy is three years or less. Promising results have been reported with high-dose therapy supported by autologous bone marrow transplantation. We conducted a randomized study comparing conventional chemotherapy and high-dose therapy.
  
  
  METHODS
  Two hundred previously untreated patients under the age of 65 years who had myeloma were randomly assigned at the time of diagnosis to receive either conventional chemotherapy or high-dose therapy and autologous bone marrow transplantation.
  
  
  RESULTS
  The response rate among the patients who received high-dose therapy was 81 percent (including complete responses in 22 percent and very good partial responses in 16 percent), whereas it was 57 percent (complete responses in 5 percent and very good partial responses in 9 percent) in the group treated with conventional chemotherapy (P < 0.001). The probability of event-free survival for five years was 28 percent in the high-dose group and 10 percent in the conventional-dose group (P = 0.01); the overall estimated rate of survival for five years was 52 percent in the high-dose group and 12 percent in the conventional-dose group (P = 0.03). Treatment-related mortality was similar in the two groups.
  
  
  CONCLUSIONS
  High-dose therapy combined with transplantation improves the response rate, eventfree survival, and overall survival in patients with myeloma.
authors.affiliation: Department of Hematology, Hôpital Purpan, Toulouse, France.
authors.forename: M
authors.initials: M
authors.lastname: Attal
authors.forename: J L
authors.initials: JL
authors.lastname: Harousseau
authors.forename: A M
authors.initials: AM
authors.lastname: Stoppa
authors.forename: J J
authors.initials: JJ
authors.lastname: Sotto
authors.forename: J G
authors.initials: JG
authors.lastname: Fuzibet
authors.forename: J F
authors.initials: JF
authors.lastname: Rossi
authors.forename: P
authors.initials: P
authors.lastname: Casassus
authors.forename: H
authors.initials: H
authors.lastname: Maisonneuve
authors.forename: T
authors.initials: T
authors.lastname: Facon
authors.forename: N
authors.initials: N
authors.lastname: Ifrah
authors.forename: C
authors.initials: C
authors.lastname: Payen
authors.forename: R
authors.initials: R
authors.lastname: Bataille
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D016026:Bone Marrow Transplantation; D002330:Carmustine / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D015999:Multivariate Analysis; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D016879:Salvage Therapy; D016019:Survival Analysis; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D008558:Melphalan; D002330:Carmustine; D011241:Prednisone