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N/A Completed N=31 Supportive Care

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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