A Placebo-Controlled Study on the Effect of r-huEPO in Patients With Multiple Myeloma Followed by an Open-Label Extension
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Proportion of patients requiring transfusion and number of units transfused relative to whether or not patients received transfusion(s) before the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Institutional Review Board