Trial information
A Study of Mircera in Anemic Patients With Multiple Myeloma
Status: Completed
Protocol number: BA16558
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
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. Target sample size is 40.
Study phase: II
Study type: Interventional; Treatment; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Hemoglobin level, and change from baseline, at week 6
Key secondary outcomes: 1. Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/02/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Czech Republic
Poland
- Bialystok
- Gdansk
- Lublin
- Warszawa
