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A Study of the Quality of Life and Treatment Response to Once Weekly NeoRecormon (Epoetin Beta) Treatment in Anemic Patients With Solid and Lymphoid Malignancies.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00776425
First received: October 20, 2008
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

This 2 arm study will investigate Quality of Life response in anemic patients with solid and lymphoid malignancies, who are receiving concomitant chemotherapy. Patients in treatment Arm 1 with solid and lymphoid malignancies will receive NeoRecormon at a dose of 150 IU/kg three times weekly. Patients in treatment Arm 2 with lymphoid malignancies will receive NeoRecormon 30,000 IU s.c. once weekly. The anticipated time on study treatment is up to 1 year, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Anemia
 Drug: epoetin beta [NeoRecormon]
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: QUALITY OF LIFE BENEFIT IN ANEMIC CANCER PATIENTS TREATED WITH NEORECORMON (EPOETIN BETA): QUALITY OF LIFE TREATMENT RESPONSE AND CLINICAL EVALUATION OF ONCE-WEEKLY DOSING

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Clinical: Hematological response - increase in hemoglobin of at least 2 g/dL within the previous 6 weeks. [ Time Frame: Baseline, 3-4 weeks, 6-8 weeks, 10-12 weeks and 14-16 weeks after study start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life Response - level of reduction of QoL deficit as compared to the population norm [ Time Frame: Baseline, 3-4 weeks, 6-8 weeks, 10-12 weeks and 14-16 weeks after study start ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: March 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: epoetin beta [NeoRecormon]
150 IU/kg three times per week
Experimental: 2 Drug: epoetin beta [NeoRecormon]
30,000 IU once weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female patients;
  • >=18 years of age;
  • anemia and prescribed treatment with NeoRecormon;
  • confirmed diagnosis of a solid or lymphoid hematologic malignancy;
  • receiving or scheduled to receive chemotherapy;
  • life expectancy of >=6 months.

Exclusion Criteria:

  • anemia after bleeding, hemolytic anemia, megaloblastic anemia, anemia in chronic kidney failure, lever and endocrinology diseases;
  • contraindications to NeoRecormon;
  • administration of NeoRecormon during chemotherapy (e.g. on the third day after chemotherapy cycle start);
  • bleeding within one month before and/or during study;
  • severe infection within one month before and/or during study;
  • inability of patient to fill the questionnaires in.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776425

Locations
Russian Federation
Arkhangelsk, Russian Federation, 163061
Barnaul, Russian Federation, 656049
Belgorod, Russian Federation, ND
Ivanovo, Russian Federation, 153040
Kazan, Russian Federation, 420111
Kostroma, Russian Federation, 156005
Lipetsk, Russian Federation, 398005
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 105203
Novosibirsk, Russian Federation, 630091
Petrozavodsk, Russian Federation, 185019
Ryazan, Russian Federation, 390039
Salekhard, Russian Federation, 629001
Soshi, Russian Federation, 354057
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation, 197758
St Petersburg, Russian Federation, 191024
Surgut, Russian Federation, 628408
Tumen, Russian Federation, 625023
Tver, Russian Federation, 170008
UFA, Russian Federation, 450005
Yaroslavl, Russian Federation, 150062
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00776425     History of Changes
Other Study ID Numbers: ML20197
Study First Received: October 20, 2008
Last Updated: February 4, 2013
Health Authority: Russia: Ministry of Health of Russian Federation

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013