Anemia, Multiple Myeloma, Plasma Cell Neoplasm
Conditions
Keywords
anemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
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.
Interventions
BIOLOGICALepoetin alfa
Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
Sponsors
National Cancer Institute (NCI)
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin at Day 28 | Baseline to Day 28 | Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa. |
| Number of Patients With an at Least 1gm/dL Increase in Hgb | Baseline to Day 28 | — |
| Number of Patients With an at Least 2gm/dL Increase in Hgb | Baseline to Day 28 | — |
Countries
United States
Participant flow
Recruitment details
From 9/2003 to 6/2008, a total of 31 patients were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Epoetin Alfa - 80,000 U sc 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
epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Epoetin Alfa - 80,000 U sc |
|---|---|
| Age, Continuous | 61.9 years |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Change From Baseline in Hemoglobin at Day 28
Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Epoetin Alfa - 80,000 U sc | Change From Baseline in Hemoglobin at Day 28 | 1.3 g/dL |
Primary
Number of Patients With an at Least 1gm/dL Increase in Hgb
Time frame: Baseline to Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Alfa - 80,000 U sc | Number of Patients With an at Least 1gm/dL Increase in Hgb | 13 participants |
Primary
Number of Patients With an at Least 2gm/dL Increase in Hgb
Time frame: Baseline to Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Alfa - 80,000 U sc | Number of Patients With an at Least 2gm/dL Increase in Hgb | 9 participants |