Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center open label, randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied. The study will be performed according to the ICH-GCP guidelines. In order to be eligible, the patient must consent in writing that he/she agrees to participate in the study. The patient recruitment period is estimated to be no longer than 18 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sundsvall Hospital
• Treatments: Epoetin Alfa; Ferric Oxide, Saccharated

Criteria

Inclusion Criteria:

• Multiple myeloma, indolent NHL or CLL

• Anemia of cancer with a Hb concentration within the range ³ 90 - £ 110 g/L measured at two different occasions with at least two weeks interval but inclusion within 4 weeks after the first Hb measurement.

• Age >18 years.

• Informed consent in writing.

• Demonstration of stainable iron in bone-marrow aspirate.

Exclusion Criteria:

• Planned or expected antineoplastic therapy (except systemic low dose maintenance corticosteroids) within the 6 weeks following inclusion.

• Cytostatic or any other antitumor therapy (except systemic low dose maintenance corticosteroids) within 8 weeks before inclusion.

• RBC transfusion within 8 weeks before inclusion.

• RHuEPO treatment within 12 weeks before inclusion.

• Any iron therapy within 4 weeks before inclusion.

• Ongoing infectious disease.

• Active inflammatory disease other than the malignant disease.

• Performance status ³ 3 according to the ECOG scale.

• Folate deficiency (S-folate < 4,5 nmol/L).

• B12 deficiency (S-cobalamin < 145 pmol/L).

• Ongoing haemolysis defined as S-haptoglobin < 0,2 g/L

• Impaired kidney function (S-Creatinine > 175 mmol/L)

• Acute or chronic clinical relevant hepatic dysfunction (S-bilirubin >40 umol/L)

• S-Ferritin >800 ug/L

• Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia.

• Unstable or uncontrolled disease related to or affecting cardiac function e.g., unstable angina, congestive heart failure (NYHA>Class ll), uncontrolled hypertension (diastolic BP >100 mmHg) and/or uncontrolled cardiac arrhythmia.

• Known history of allergy to any of the study medications or their excipients.

• Concurrent treatment with experimental drugs not approved by Läkemedelsverket.

• Male and female patients with reproductive potential must use an approved contraceptive method (e.g. intrauterine device (IUD), birth control pills or barrier device) during the study and for 3 months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.