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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C.E.R.A. | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin level, and change from baseline, at week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malgorzata Rokicka, Dr | unaffliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prague | 128 08 | Czechia | ||||
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Bialystok |
| 15-276 |
| Poland |
| Gdansk | 80-211 | Poland |
| Lublin | 20-081 | Poland |
| Warsaw | 02-097 | Poland |