The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 1996-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients with documented multiple myeloma defined by standard criteria, with at least 6 months having elapsed since beginning chemotherapy

• having a self-care performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a score ranging from 0 [fully active, no disease restriction] to 3 [capable of only limited self-care, confined to bed or chair more than 50% of waking hours])

• having a life expectancy of at least 3 months

• having a baseline hemoglobin <11 g/dL and baseline count of <100,000 microliter for developing red cells

• with an ability to administer self-injections

Exclusion Criteria:

• Patients having clinically significant disease other than cancer

• having evidence of uncontrolled hypertension or a history of seizure

• having untreated iron, folate, or Vitamin B12 deficiency

• receiving a transfusion within 7 days of study entry, or androgen therapy within 1 month of study entry

• receiving dialysis at baseline screening