The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma
A Placebo-Controlled Study on the Effect of r-huEPO in Patients With Multiple Myeloma Followed by an Open-Label Extension
1 other identifier
interventional
156
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 1995
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 1996
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 26, 2005
CompletedMay 18, 2011
January 1, 2011
December 22, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients requiring transfusion and number of units transfused relative to whether or not patients received transfusion(s) before the study.
Secondary Outcomes (1)
Increase in hemoglobin, hematocrit, developing red blood cells in the blood; Changes in quality-of-life; Safety evaluations (incidence of adverse events, laboratory tests, and vital signs) including changes in underlying multiple myeloma.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Start
January 1, 1995
Study Completion
September 1, 1996
Last Updated
May 18, 2011
Record last verified: 2011-01