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A Study of Mircera in Anemic Patients With Multiple Myeloma

NCT00360347 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-03-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

C.E.R.A.

Sponsors & Collaborators

Principal Investigators

  • Malgorzata Rokicka, Dr · unaffliated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-29
Primary Completion
2003-04-29
Completion
2003-04-29

Countries

  • Czechia
  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360347 on ClinicalTrials.gov