The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma
Condition: Anemia; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus
      placebo in reducing the transfusion requirements in anemic patients with multiple myeloma,
      and to investigate the quality-of-life benefits associated with the use of epoetin alfa.
      Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
    

Detailed description: 
      Cancer patients often experience anemia due to the disease itself, chemotherapy or both.
      Quality of life is also affected, in part because of the fatigue associated with anemia.
      Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level
      may improve quality of life and help patients live longer. This study is a 12-week
      randomized, double-blind, placebo-controlled, multicenter study (with an open-label
      extension) to assess the effectiveness of treatment with epoetin alfa in reducing the need
      for red cell transfusion by improving anemia in patients with multiple myeloma whose
      hemoglobin is less than 11 grams per deciliter. There will be 4 groups of patients in the
      study. Patients will first be placed into 2 groups according to whether or not they received
      at least 1 blood transfusion within the previous 3 months. Within each of these 2 groups,
      patients will then be randomly assigned to receive either epoetin alfa or placebo for 12
      weeks. Dosing is initiated at 150 units per kilogram (U/kg) injected under the skin 3 times
      weekly for 4 weeks, then either continued at 150 U/kg or adjusted to 300 U/kg according to
      hemoglobin levels for the remaining 8 weeks. All patients who complete the 12-week
      double-blind period will be eligible to continue receiving epoetin alfa for an additional 12
      weeks in an open-label extension of the study. The primary measures of effectiveness will be
      determined by the number of units of blood transfused, the proportion of patients requiring
      transfusion, and the number of units transfused relative to whether or not they received
      transfusions before the study. Additional effectiveness measures include the number of
      patients whose hemoglobin level reach at least 12 grams per deciliter (anemia considered
      "corrected") or who have an increase in hemoglobin of at least 2 grams per deciliter, and the
      change in the percentage of red blood cells and number of developing red blood cells in the
      blood. Changes in quality-of-life (Nottingham and visual analog scale) and performance scores
      will also be measured. Safety evaluations (incidence of adverse events, laboratory tests, and
      vital signs) and changes in underlying multiple myeloma will be assessed. The hypothesis of
      the study is that epoetin alfa will be superior to placebo in reducing the need for
      transfusions and improving anemia and quality of life. Double-blind: Epoetin alfa 150 units
      per kilogram (U/kg) injected under the skin 3 times weekly for 4 weeks; then either continued
      at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks.
      Open-label: dose to maintain target hemoglobin range.
    

Intervention name(s): epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: anemia; cancer; quality of life; chemotherapy; hemoglobin; multiple myeloma; transfusion; epoetin alfa; epoetin; erythropoietin