Clinical trial · Interventional
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
NCT00270101CI-TRIAL-00004871completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.