A Study of Mircera in Anemic Patients With Multiple Myeloma
Phase 1
Completed
- Conditions
- Anemia
- Registration Number
- NCT00360347
- Lead Sponsor
- Hoffmann-La Roche
- 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 subcutaneous injections of Mircera once every 3 weeks, at doses of 2.0, 3.5 or 5.0 micrograms/kg. Following the administration of 2 doses, an evaluation of hemoglobin increase will be made at week 6. In the second stage, further groups of patients will receive additional doses of Mircera,at doses of 1.0, 6.5 or 8.0 micrograms/kg, depending on efficacy, safety and pharmacokinetic considerations.The anticipated time on treatment is 3-12 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hemoglobin level, and change from baseline, at week 6
- Secondary Outcome Measures
Name Time Method Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure