BACKGROUND: To determine the efficacy of epoetin alfa for the treatment of the anemia of multiple myeloma, a prospective, randomized, placebo-controlled, double-blind clinical trial enrolled 25 patients with the anemia of multiple myeloma and a hematocrit less than 0.30. METHODS:Epoetin alfa, 150 U/kg, or a matching volume of placebo was administered subcutaneously three times per week for 6 weeks. If the criterion for a response was not met, the dose was doubled. After 12 weeks, nonresponders in the placebo arm were switched to an open-label study of epoetin alfa at a dose of 150 U/kg for 6 weeks. After 6 weeks, the dose was doubled if no response was obtained. A partial response was defined as an increase of 6 percentage points or greater in the hematocrit without transfusion. A complete response required a final hematocrit of 0.38 or greater without transfusion. Complete responders had reduction of epoetin alfa to the lowest dose capable of maintaining the complete response. RESULTS:Twenty patients were evaluable for response to therapy. During the double-blind phase, six patients who were receiving epoetin alfa had a complete response, one had a partial response, and three were non-responders. No responses occurred in the placebo arm. In the open-label phase, of the 10 patients who were originally receivingplacebo, three had a complete response, one had a partial response, and six were nonresponders. Chemotherapy, pretreatment serum erythropoietin levels, disease duration, and reticulocyte count did not predict the response to epoetin alfa. The median final dose for the responding group was 120 U/kg three times per week to maintain a hematocrit greater than 0.38. There was no effect on the course of the myeloma, and no hypertension was seen. CONCLUSION: Treatment with epoetin alfa is effective and safe in patients with the anemia of multiple myeloma.
RCT Entities:
BACKGROUND: To determine the efficacy of epoetin alfa for the treatment of the anemia of multiple myeloma, a prospective, randomized, placebo-controlled, double-blind clinical trial enrolled 25 patients with the anemia of multiple myeloma and a hematocrit less than 0.30. METHODS:Epoetin alfa, 150 U/kg, or a matching volume of placebo was administered subcutaneously three times per week for 6 weeks. If the criterion for a response was not met, the dose was doubled. After 12 weeks, nonresponders in the placebo arm were switched to an open-label study of epoetin alfa at a dose of 150 U/kg for 6 weeks. After 6 weeks, the dose was doubled if no response was obtained. A partial response was defined as an increase of 6 percentage points or greater in the hematocrit without transfusion. A complete response required a final hematocrit of 0.38 or greater without transfusion. Complete responders had reduction of epoetin alfa to the lowest dose capable of maintaining the complete response. RESULTS: Twenty patients were evaluable for response to therapy. During the double-blind phase, six patients who were receiving epoetin alfa had a complete response, one had a partial response, and three were non-responders. No responses occurred in the placebo arm. In the open-label phase, of the 10 patients who were originally receiving placebo, three had a complete response, one had a partial response, and six were nonresponders. Chemotherapy, pretreatment serum erythropoietin levels, disease duration, and reticulocyte count did not predict the response to epoetin alfa. The median final dose for the responding group was 120 U/kg three times per week to maintain a hematocrit greater than 0.38. There was no effect on the course of the myeloma, and no hypertension was seen. CONCLUSION: Treatment with epoetin alfa is effective and safe in patients with the anemia of multiple myeloma.
Authors: Julia Bohlius; Kurt Schmidlin; Corinne Brillant; Guido Schwarzer; Sven Trelle; Jerome Seidenfeld; Marcel Zwahlen; Mike J Clarke; Olaf Weingart; Sabine Kluge; Margaret Piper; Maryann Napoli; Dirk Rades; David Steensma; Benjamin Djulbegovic; Martin F Fey; Isabelle Ray-Coquard; Volker Moebus; Gillian Thomas; Michael Untch; Martin Schumacher; Matthias Egger; Andreas Engert Journal: Cochrane Database Syst Rev Date: 2009-07-08
Authors: James H Rosberg; Rym Ben-Hamadi; Pierre Y Cremieux; John M Fastenau; Catherine Tak Piech Journal: Clin Drug Investig Date: 2005 Impact factor: 2.859