Clinical trial · Interventional
Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma
A Single Institution, Open-Label, Nonrandomized Pilot Study of High Dose Epoetin Alfa Administered Once a Week in Patients With Multiple Myeloma: Its Effects on Hemoglobin, Blood Transfusion Requirements and Quality of Life
NCT00400686CI-TRIAL-00031749completedN/AResults postedClinicalTrials.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)
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia in patients with multiple myeloma. PURPOSE: This clinical trial is studying how well epoetin alfa works in treating anemia in patients undergoing chemotherapy for multiple myeloma.
Conditions
Conditions (3)
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 |
| Plasma Cell Neoplasm | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epoetin Alfa - 80,000 U sc
- description
- Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
- interventionNames
- Biological: epoetin alfa
Primary outcomes (3)
- measure
- Change From Baseline in Hemoglobin at Day 28
- timeFrame
- Baseline to Day 28
- description
- Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
- measure
- Number of Patients With an at Least 1gm/dL Increase in Hgb
- timeFrame
- Baseline to Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma (MM) * Requiring active therapy for MM * Planning to undergo chemotherapy for ≥ 3 months * Moderate anemia caused by MM and/or chemotherapy, as evidenced by hemoglobin ≤ 11.0 g/dL * No untreated anemia predominantly due to factors other than MM/chemotherapy (i.e., iron or folate deficiencies, hemolysis, HIV, or gastrointestinal bleeding) PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Life expectancy ≥ 6 months * Transferrin saturation ≥ 20% * Ferritin ≥ 100 ng/mL * Homocysteine normal (concurrent vitamin supplementation allowed) * Methylmalonic acid normal (concurrent vitamin supplementation allowed) * Renal function normal * No uncontrolled hypertension * No prior thrombotic events unless treated with appropriate prophylaxis * No known hypersensitivity to mammalian cell-derived products * No uncontrolled infection * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Weight \< 100 Kg * Patients with iron, folate, or vitamin B\_12 deficiency allowed provided conditions are corrected prior to study entry * Able to read and understand English at a 7th grade level PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior total lymphoid, extensive abdominal, or inverted Y radiotherapy * Concurrent red blood cell transfusion allowed provided hemoglobin ≤ 7 g/dL AND patient is symptomatic * Concurrent vitamin supplementation allowed for cyanocobalamin (vitamin B\_12) or folate deficiency
References
Publications (0)
Data not yet available
No reference posted for this study.