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A Study of Mircera in Anemic Patients With Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00360347
First Posted: August 4, 2006
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Anemia Drug: C.E.R.A. Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Enrollment: 64
Actual Study Start Date: November 2001
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360347


Locations
Czechia
Praha, Czechia, 128 08
Poland
Bialystok, Poland, 15-276
Gdansk, Poland, 80-211
Lublin, Poland, 20-081
Warszawa, Poland, 02-097
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Principal Investigator: Malgorzata Rokicka, Dr unaffliated
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00360347     History of Changes
Other Study ID Numbers: BA16558
First Submitted: August 3, 2006
First Posted: August 4, 2006
Last Update Posted: May 31, 2017
Last Verified: January 2008

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases