Status:
COMPLETED
A Study of Mircera in Anemic Patients With Multiple Myeloma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will investigate the efficacy, safety and pharmacokinetics of Mircera in adult anemic patients with multiple myeloma. In the first stage of the study, patients will be randomized to receive...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- confirmed diagnosis of multiple myeloma;
- anemia (hemoglobin \<=11g/dL at screening visit).
Exclusion
- 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.
Key Trial Info
Start Date :
November 29 2001
Trial Type :
INTERVENTIONAL
End Date :
April 29 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00360347
Start Date
November 29 2001
End Date
April 29 2003
Last Update
March 1 2018
Active Locations (5)
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1
Prague, Czechia, 128 08
2
Bialystok, Poland, 15-276
3
Gdansk, Poland, 80-211
4
Lublin, Poland, 20-081