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
- adult patients, >=18 years of age;
- confirmed diagnosis of multiple myeloma;
- anemia (hemoglobin <=11g/dL at screening visit).
- transfusion of red blood cells during 2 months prior to first planned dose of study
- therapy-resistant hypertension;
- relevant acute or chronic bleeding within 3 months prior to planned start of study
- recombinant human erythropoietin or erythropoiesis-stimulating drug therapy within 3
months prior to planned start of study treatment.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Hemoglobin level, and change from baseline, at week 6
Malgorzata Rokicka, Dr
Poland: Office for Registration of Medical Products, Medical Devices and Biocides
- Multiple Myeloma
- Neoplasms, Plasma Cell