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

This study has been completed.
Sponsor:
Information provided by:
Sundsvall Hospital
ClinicalTrials.gov Identifier:
NCT00145652
First received: September 1, 2005
Last updated: July 27, 2007
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Anemia
Multiple Myeloma
Non Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Drug: Neo-Recormon and Venofer
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders

Resource links provided by NLM:


Further study details as provided by Sundsvall Hospital:

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.

Estimated Enrollment: 66
Study Start Date: December 2003
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145652

Locations
Sweden
Michael Hedenus
Sundsvall, Sweden, S 851 86
Sponsors and Collaborators
Sundsvall Hospital
Investigators
Principal Investigator: Michael Hedenus, MD Unaffilitated
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00145652     History of Changes
Other Study ID Numbers: 1-Hedenus, Medical Products Agency, Dnr:151:2003/29970
Study First Received: September 1, 2005
Last Updated: July 27, 2007
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sundsvall Hospital:
erythropoetin
adjuvant iron therapy
anemia
cancer

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases
Leukemia
Leukemia, B-Cell
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014