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

July 27, 2007 updated by: Sundsvall Hospital

Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 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.

Study Type

Interventional

Enrollment

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Sundsvall, Sweden, S 851 86
        • Michael Hedenus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the mean change in hemoglobin (Hb) concentrations from baseline to EOT (End of treatment ) between the two treatment groups.

Secondary Outcome Measures

Outcome Measure
The percentage of subjects with Hb response defined by an increase in the Hb concentration by at least 20 g/L in the absence of any RBC transfusion.
The time needed to obtain a Hb response.
The fraction of subjects receiving RBC transfusions during the study period.
The dose of rHuEPO used.
The effect on iron-status.
The weekly Hb concentration profile over time.
The frequency and grade of adverse reactions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundsvall Hospital

Investigators

  • Principal Investigator: Michael Hedenus, MD, unaffilitated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2007

Last Update Submitted That Met QC Criteria

July 27, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Hedenus
  • Medical Products Agency
  • Dnr:151:2003/29970

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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