A Study of Mircera in Anemic Patients With Multiple Myeloma

Roche

Status and phase

Completed

Phase 2

Phase 1

Conditions

Anemia

Treatments

Drug: C.E.R.A.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00360347

BA16558

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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.