NCT00360347

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2001

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

August 3, 2006

Last Update Submit

February 27, 2018

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin level, and change from baseline, at week 6

Secondary Outcomes (1)

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

Interventions

C.E.R.A.DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>=18 years of age;
  • confirmed diagnosis of multiple myeloma;
  • anemia (hemoglobin \<=11g/dL at screening visit).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Prague, 128 08, Czechia

Location

Unknown Facility

Bialystok, 15-276, Poland

Location

Unknown Facility

Gdansk, 80-211, Poland

Location

Unknown Facility

Lublin, 20-081, Poland

Location

Unknown Facility

Warsaw, 02-097, Poland

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Malgorzata Rokicka, Dr

    unaffliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 4, 2006

Study Start

November 29, 2001

Primary Completion

April 29, 2003

Study Completion

April 29, 2003

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

PL(4)CZ(1)