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A Study of Mircera in Anemic Patients With Multiple Myeloma

Primary Purpose

Anemia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
C.E.R.A.
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Outcomes

Primary Outcome Measures

Hemoglobin level, and change from baseline, at week 6

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2006
Last Updated
February 27, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00360347
Brief Title
A Study of Mircera in Anemic Patients With Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 29, 2001 (Actual)
Primary Completion Date
April 29, 2003 (Actual)
Study Completion Date
April 29, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
C.E.R.A.
Primary Outcome Measure Information:
Title
Hemoglobin level, and change from baseline, at week 6
Secondary Outcome Measure Information:
Title
Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malgorzata Rokicka, Dr
Organizational Affiliation
unaffliated
Official's Role
Principal Investigator
Facility Information:
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

A Study of Mircera in Anemic Patients With Multiple Myeloma

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