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NCT00400686 · REGISTRY CONDITION SEARCH

Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2018-02-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change From Baseline in Hemoglobin at Day 28

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outcome · POSTED

Number of Patients With an at Least 1gm/dL Increase in Hgb

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outcome · POSTED

Number of Patients With an at Least 2gm/dL Increase in Hgb

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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
    intervention Names
    1. Biological: epoetin alfa
    label
    Epoetin Alfa - 80,000 U sc
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Epoetin Alfa - 80,000 U sc
    description
    Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
    name
    epoetin alfa
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
31
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
    measure
    Change From Baseline in Hemoglobin at Day 28
    time Frame
    Baseline to Day 28
  2. measure
    Number of Patients With an at Least 1gm/dL Increase in Hgb
    time Frame
    Baseline to Day 28
  3. measure
    Number of Patients With an at Least 2gm/dL Increase in Hgb
    time Frame
    Baseline to Day 28
Full study description
brief 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.
detailed Description
OBJECTIVES: Primary * Determine the hematologic response and transfusion requirements of chemotherapy-related moderate anemia to the administration of a high initial dose of epoetin alfa followed by a less frequent maintenance dose of epoetin alfa in multiple myeloma patients. Secondary * Determine the effect of moderate anemia on quality of life in these patients. * Correlate changes in hemoglobin levels with changes in quality of life in patients treated with this drug. * Determine the effect of this drug on transfusion requirements after day 28 in these patients. OUTLINE: This is an open-label, non-randomized, pilot study. Patients receive high-dose epoetin alfa subcutaneously (SC) once a week for 4 weeks or until their hemoglobin levels reach 12-13 g/dL. Patients then receive epoetin alfa SC once every 2 weeks for 8 weeks OR once a week for 4 weeks, and then once every 2 weeks for 8 weeks (as long as their hemoglobin levels remain between 12-13 g/dL). Patients then receive maintenance epoetin alfa SC once every 4 weeks for up to 12 weeks. Patients whose hemoglobin level decreases by 1-1.5 g/dL return to previous epoetin alfa schedule. Patients whose hemoglobin level is \< 9 g/dL after returning to the previous schedule may receive epoetin alfa for an additional 24 weeks. Quality of life is assessed at baseline and at weeks 2, 4, 8, 16, and 24 weeks during treatment. After completion of study treatment, patients are followed periodically for survival. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Source references
Source notices and limitations
    Discovery and provenance
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      payload
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      occurrences
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        exact text
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        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice