Status:
COMPLETED
The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Multiple Myeloma
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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 investiga...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1996
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00270101
Start Date
January 1 1995
End Date
September 1 1996
Last Update
May 18 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.