Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360347
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2006-08-03
Brief Title:
A Study of Mircera in Anemic Patients With Multiple Myeloma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20 35 or 50 microgramskg 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 Mirceraat doses of 10 65 or 80 microgramskg depending on efficacy safety and pharmacokinetic considerationsThe anticipated time on treatment is 3-12 months and the target sample size is 100 individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None