TY - JOUR
T1 - Epoetin Alfa for the Treatment of the Anemia of Multiple Myeloma
T2 - A Prospective, Randomized, Placebo-Controlled, Double-blind Trial
AU - Garton, John P.
AU - Gertz, Morie A.
AU - Witzig, Thomas E.
AU - Greipp, Philip R.
AU - Lust, John A.
AU - Schroeder, Georgene
AU - Kyle, Robert A.
PY - 1995/10/23
Y1 - 1995/10/23
N2 - 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 nonresponders. 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.
AB - 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 nonresponders. 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.
UR - http://www.scopus.com/inward/record.url?scp=0028803524&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0028803524&partnerID=8YFLogxK
U2 - 10.1001/archinte.1995.00430190059008
DO - 10.1001/archinte.1995.00430190059008
M3 - Article
C2 - 7575066
AN - SCOPUS:0028803524
SN - 0003-9926
VL - 155
SP - 2069
EP - 2074
JO - Archives of internal medicine
JF - Archives of internal medicine
IS - 19
ER -