A Study of Mircera in Anemic Patients With Multiple Myeloma

Anemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360347
• Other study ID #: BA16558
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 3, 2006
• Last updated: February 27, 2018
• Start date: November 29, 2001
• Est. completion date: April 29, 2003

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 29, 2003
• Est. primary completion date: April 29, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Multiple Myeloma

Intervention

Drug:
• C.E.R.A.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level, and change from baseline, at week 6
Secondary	Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure