Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders
18 Months
N/A
Both
Anemia, Multiple Myeloma, Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Trial Information
Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders
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, in patients with LPD not receiving antineoplastic therapy will
be studied.
LENGTH OF STUDY 16 weeks
NUMBER OF CENTERS 15
NUMBER OF SUBJECTS 66
STRATIFICATION 1. According to diagnosis; CLL and indolent NHL vs. MM. 2. According to level
of S-epo > 100 IU/L vs £ 100 IU/L at baseline.
TREATMENT The patients will be randomized to receive 30 000 IU Neorecormon â (epoetin beta)
s.c. once / week for 16 consecutive weeks +/- 100mg/week of Venofer â (iron sucrose) from
week 0 to 6, followed by one 100mg dose every 2 week from weeks 8 until 14.
If the increase in Hb concentration is less than 10g/L from baseline (week 0) until week 4
weeks, the dose of epoetin beta will be increased to 60 000 IU weekly from week 5.
If the Hb concentration exceeds 140 g/L, the epoetin beta therapy will be suspended. The
treatment will be resumed once the Hb concentration falls below 130 g/L. This resumed dose
will be 75% of the previous dose (e.g. if the previous dose was 30 000 IU before suspension,
the continued dose should be 22 500 IU. If the dose was 60 000 IU before suspension, the
dose should be 45 000 IU).
If the level of S-ferritin reaches >1000 ug/L iron sucrose should be suspended until the
S-ferritin level falls below 500 ug/L.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare the mean change in hemoglobin (Hb) concentrations from baseline to EOT (End of treatment ) between the two treatment groups.
Principal Investigator
Michael Hedenus, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Unaffilitated
Authority:
Sweden: Medical Products Agency
Study ID:
1-Hedenus
NCT ID:
NCT00145652
Start Date:
December 2003
Completion Date:
December 2005
Related Keywords:
- Anemia
- Multiple Myeloma
- Non Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
- erythropoetin
- adjuvant iron therapy
- anemia
- cancer
- Anemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoproliferative Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
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