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The Effects of PROCRIT (Epoetin Alfa) on Hemoglobin, Symptom Distress, and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia

Phase 4
18 Years
Not Enrolling
Chemotherapy, Anemia, Cancer

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Trial Information

The Effects of PROCRIT (Epoetin Alfa) on Hemoglobin, Symptom Distress, and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia

This study was an open-label (patients and investigators knew what treatment was being
given), randomized (patients were assigned to a treatment group by chance) study of
lymphoma, chronic lymphocytic leukemia (CLL), or multiple myeloma patients. This study
addressed the clinical and patient-management consequences of treating mild to moderate
anemia (hemoglobin (Hb) between 10 and 12 g/dL). The design of the study compared the effect
of treating higher Hb levels to current standard of care criteria on Hb levels, transfusion
requirements, and patient reported outcomes (quality of life, health care resource
utilization, and productivity). Patients were randomized according to their Hb levels. Two
entry criteria were specified during the course of the trial. Initially, patients were
enrolled with Hb levels >= 11 g/dL and then randomized to receive 1) Immediate epoetin alfa
treatment or 2) Observed after Hb levels fell below 11 g/dL. Epoetin alfa treatment was
provided to the Observed group if and when Hb levels fell below 9.0 g/dL. Slow recruitment
of patients in to the study resulted in a protocol amendment. Subsequently, if a patient
presented with a Hb between 10 and 12 g/dL, the patient was randomized to the Immediate or
to the Observed groups. Patients presenting with Hgb > 12 g/dL but otherwise eligible, were
not randomized until Hb dropped to <=12 g/dL. Patients remained in the study for up to 36
weeks. Safety assessments were performed throughout the study and included obtaining and
evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and
severity of adverse events. The starting dose of PROCRIT (Epoetin alfa) was administered
subcutaneously (sc) as 40,000 Units (U) once weekly (qw). If after 3-4 weeks of therapy,
the Hb did not increase by > 1.0 g/dL, the dose was increased to 60,000 U sc qw. If at any
time, the Hb rose above 15 g/dL on 2 consecutive evaluations, PROCRIT (Epoetin alfa) was
stopped until the Hb dropped to below 13 g/dL and then resumed.

Inclusion Criteria:

- Patients must present with non-Hodgkins Lymphoma (Low, Intermediate or High Grade) or
Hodgkins Disease, CLL or Multiple Myeloma

- Life expectancy > 6 months with Karnofsky Performance Index of > =70

- Evaluable lesion as objective indicator of response

- Scheduled for at least one myelosuppressive cytotoxic regimen (experimental
chemotherapy allowed) for at least 4-6 months

- Patients with reproductive potential must have used an adequate contraceptive method

- Transferrin saturation = 20% and serum ferritin = 50 ng/mL Bone marrow evaluations
may be performed to determine if iron stores are adequate

- histologic documentation of disease.

Exclusion Criteria:

- Patients with no second active malignancy or history of other malignancy diagnosed
within preceding 5 years (other than basal cell carcinoma or cervical cancer)

- No uncontrolled hypertension

- active, unresolved infection

- anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, hemolysis,
or GI bleeding

- Receiving Epoetin alfa independent of protocol

- Received chemotherapy with the previous 14 days

- Prior total lymphoid, extensive abdominal or inverted Y radiation therapy

- No use of interferons or interleukins during study

- No use of nonchemotherapy experimental agents within preceding 30 days

- No Hodgkins Disease patients who are chemotherapy naïve

- Received stem cell transplant.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure the change in quality of life score as demonstrated by the FACT-An (Functional Assessment in Cancer Therapy - Anemia) and LASA (Linear Analogue Assessment Scale) tools over the 36 week study period.

Principal Investigator

Ortho Biotech, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Ortho Biotech, Inc.


United States: Institutional Review Board

Study ID:




Start Date:

July 1996

Completion Date:

November 2002

Related Keywords:

  • Chemotherapy
  • Anemia
  • Cancer
  • Anemia
  • hemoglobin
  • chemotherapy
  • hematologic response
  • subcutaneous injection
  • Epoetin alfa
  • FACT-An
  • LASA
  • Anemia
  • Leukemia, Lymphocytic, Chronic, B-Cell