Trial Information
Open Label, Randomized, Exploratory Study to Investigate the Hemoglobin Dose-Response, the Safety and the Pharmacokinetic Profile Following Subcutaneous Administration of Mircera Once Every Three Weeks to Anemic Patients With Multiple Myeloma
Inclusion Criteria:
- adult patients, >=18 years of age;
- confirmed diagnosis of multiple myeloma;
- anemia (hemoglobin <=11g/dL at screening visit).
Exclusion Criteria:
- transfusion of red blood cells during 2 months prior to first planned dose of study
medication;
- therapy-resistant hypertension;
- relevant acute or chronic bleeding within 3 months prior to planned start of study
treatment;
- recombinant human erythropoietin or erythropoiesis-stimulating drug therapy within 3
months prior to planned start of study treatment.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Hemoglobin level, and change from baseline, at week 6
Principal Investigator
Malgorzata Rokicka, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
unaffliated
Authority:
Poland: Office for Registration of Medical Products, Medical Devices and Biocides
Study ID:
BA16558
NCT ID:
NCT00360347
Start Date:
Completion Date:
Related Keywords:
- Anemia
- Anemia
- Multiple Myeloma
- Neoplasms, Plasma Cell