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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia

Thank you

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

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