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A Study of Mircera in Anemic Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00360347
First received: August 3, 2006
Last updated: January 23, 2008
Last verified: January 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360347

Locations
Czech Republic
Praha, Czech Republic, 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

No publications provided

ClinicalTrials.gov Identifier: NCT00360347     History of Changes
Other Study ID Numbers: BA16558
Study First Received: August 3, 2006
Last Updated: January 23, 2008
Health Authority: Poland: Office for Registration of Medical Products, Medical Devices and Biocides

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

ClinicalTrials.gov processed this record on November 24, 2014