Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608060
Recruitment Status : Terminated (Due to poor enrollment this study was terminated prematurely.)
First Posted : November 18, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 individuals.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels of Patients With Anemia Related to Non- Hodgkin Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma, Treated With Erythropoietin B (Recormon) Using Pre-filled Syringe With 30000 IU, as Well as to Quantify the Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment
Study Start Date : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007


Arm Intervention/treatment
Experimental: Epoetin Beta - 30000 IU
Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.
Drug: Epoetin Beta
Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 g/dL versus baseline.
Other Name: Recormon




Primary Outcome Measures :
  1. Hemoglobin levels at 16 weeks [ Time Frame: 16 Weeks ]

Secondary Outcome Measures :
  1. Serum Iron, Ferritin and Transferrin Levels [ Time Frame: 16 Weeks ]
  2. Time to Global Response [ Time Frame: Up to 4 months ]
  3. Percentage of Participants with a Positive Response [ Time Frame: Weeks 4 and 8 ]
  4. Quality of Life in Relation to Grade of Anemia [ Time Frame: Up to 4 months ]
  5. Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument [ Time Frame: Up to 4 months ]
  6. Tolerability - Incidence of Adverse Events [ Time Frame: Up to 16 Weeks of treatment period ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
  • Anemia at Screening Visit

Exclusion Criteria:

  • Transfusion of red blood cells within 2 months of study drug
  • Treatment-resistant hypertension
  • Acute or chronic bleeding (requiring therapy) within 3 months of study drug

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): NCT02608060


Locations
Layout table for location information
Venezuela
Caracas, Venezuela, 1040
Caracas, Venezuela, 2122
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02608060    
Other Study ID Numbers: ML18055
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics