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A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT02564094
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: Epoetin beta Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
Study Start Date : February 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Epoetin beta
Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.
Drug: Epoetin beta
Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.
Other Name: NeoRecormon




Primary Outcome Measures :
  1. Response rate according to hemoglobin level [ Time Frame: At Week 4 ]
  2. Transfusion requirement rate [ Time Frame: From Weeks 5 to 12 ]
  3. Predictive value of reticulocyte increase [ Time Frame: At Week 2 ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to approximately 6 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adults at least 18 years of age
  • Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
  • Anemia with low erythropoeitin (EPO) levels

Exclusion Criteria:

  • Poorly controlled hypertension
  • Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
  • Treatment with EPO within the last 6 weeks
  • Pregnant or breastfeeding females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564094


Locations
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Bulgaria
Plovdiv, Bulgaria, 4000
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1756
Sofia, Bulgaria, 1757
Sofia, Bulgaria, 1784
Stara Zagora, Bulgaria, 8000
Varna, Bulgaria, 9002
Varna, Bulgaria, 9010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02564094     History of Changes
Other Study ID Numbers: ML18043
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics