Status:
COMPLETED
Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.
Lead Sponsor:
Sundsvall Hospital
Conditions:
Anemia
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ki...
Detailed Description
In this multi-center, randomized, open label phase-3 study, the correction of mild or moderate anemia and the effect on iron kinetics by rHuEPO treatment, with or without intravenous iron treatment, i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00145652
Start Date
December 1 2003
End Date
December 1 2005
Last Update
July 30 2007
Active Locations (1)
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1
Michael Hedenus
Sundsvall, Sweden, S 851 86