N/A
Completed N=31
Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma
Anemia · Multiple Myeloma · Plasma Cell Neoplasm
Source: ClinicalTrials.gov NCT00400686 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Change From Baseline in Hemoglobin at Day 28 — 1.3 g/dL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin at Day 28 |
1.3 | — |
| PRIMARY Number of Patients With an at Least 1gm/dL Increase in Hgb |
13 | — |
| PRIMARY Number of Patients With an at Least 2gm/dL Increase in Hgb |
9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00400686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.