A Study of Mircera in Anemic Patients With Multiple Myeloma

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00360347

Enrollment

Unknown

Registered

2006-08-04

Start date

2001-11-29

Completion date

2003-04-29

Last updated

2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

DRUGC.E.R.A.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Hemoglobin level, and change from baseline, at week 6	—

Secondary

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

Countries

Czechia, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026