Skip to main content
Clinical Trials/NCT00360347
NCT00360347CompletedPhase 1

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

Hoffmann-La Roche5 sites in 2 countriesStarted: November 29, 2001Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
5
Primary Endpoint
Hemoglobin level, and change from baseline, at week 6

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Hemoglobin level, and change from baseline, at week 6

Secondary Outcomes

  • Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

Loading locations...

Similar Trials