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

Primary Purpose

Anemia, Multiple Myeloma, Non Hodgkin Lymphoma

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Neo-Recormon and Venofer
Sponsored by
Sundsvall Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring erythropoetin, adjuvant iron therapy, anemia, cancer

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michael Hedenus

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 1, 2005
Last Updated
July 27, 2007
Sponsor
Sundsvall Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00145652
Brief Title
Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.
Official Title
Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sundsvall Hospital

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Multiple Myeloma, Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Keywords
erythropoetin, adjuvant iron therapy, anemia, cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Neo-Recormon and Venofer
Primary Outcome Measure Information:
Title
To compare the mean change in hemoglobin (Hb) concentrations from baseline to EOT (End of treatment ) between the two treatment groups.
Secondary Outcome Measure Information:
Title
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.
Title
The time needed to obtain a Hb response.
Title
The fraction of subjects receiving RBC transfusions during the study period.
Title
The dose of rHuEPO used.
Title
The effect on iron-status.
Title
The weekly Hb concentration profile over time.
Title
The frequency and grade of adverse reactions.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hedenus, MD
Organizational Affiliation
Unaffilitated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael Hedenus
City
Sundsvall
ZIP/Postal Code
S 851 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15051778
Citation
Auerbach M, Ballard H, Trout JR, McIlwain M, Ackerman A, Bahrain H, Balan S, Barker L, Rana J. Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. J Clin Oncol. 2004 Apr 1;22(7):1301-7. doi: 10.1200/JCO.2004.08.119.
Results Reference
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Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.

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