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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 20, 2008
Last updated: October 1, 2015
Last verified: October 2015
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
Drug: epoetin beta [NeoRecormon]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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 ]

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 ]

Enrollment: 125
Study Start Date: March 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00776425

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, 105203
Moscow, Russian Federation, 125101
Novosibirsk, Russian Federation, 630091
Petrozavodsk, Russian Federation, 185019
Ryazan, Russian Federation, 390039
Salekhard, Russian Federation, 629001
Soshi, Russian Federation, 354057
St Petersburg, Russian Federation, 191024
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation, 197758
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
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00776425     History of Changes
Other Study ID Numbers: ML20197
Study First Received: October 20, 2008
Last Updated: October 1, 2015

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics processed this record on May 25, 2017