NCT00145652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

July 30, 2007

Status Verified

September 1, 2006

First QC Date

September 1, 2005

Last Update Submit

July 27, 2007

Conditions

AnemiaMultiple MyelomaNon Hodgkin LymphomaChronic Lymphocytic Leukemia

Keywords

erythropoetinadjuvant iron therapyanemiacancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Interventions

Neo-Recormon and VenoferDRUG

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Multiple myeloma, indolent NHL or CLL
  • Age \>18 years.
  • Informed consent in writing.
  • Demonstration of stainable iron in bone-marrow aspirate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Hedenus

Sundsvall, S 851 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 15051778BACKGROUND

MeSH Terms

Conditions

AnemiaMultiple MyelomaLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellNeoplasms

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphomaLymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Michael Hedenus, MD

    Unaffilitated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

December 1, 2003

Study Completion

December 1, 2005

Last Updated

July 30, 2007

Record last verified: 2006-09

Locations

SE(1)