Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma

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.
 
ClinicalTrials.gov Identifier: NCT00270101
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE December 22, 2005
First Posted Date  ICMJE December 26, 2005
Last Update Posted Date May 18, 2011
Study Start Date  ICMJE January 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Proportion of patients requiring transfusion and number of units transfused relative to whether or not patients received transfusion(s) before the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00270101 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Increase in hemoglobin, hematocrit, developing red blood cells in the blood; Changes in quality-of-life; Safety evaluations (incidence of adverse events, laboratory tests, and vital signs) including changes in underlying multiple myeloma.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma
Official Title  ICMJE A Placebo-Controlled Study on the Effect of r-huEPO in Patients With Multiple Myeloma Followed by an Open-Label Extension
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing the transfusion requirements in anemic patients with multiple myeloma, and to investigate the quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Detailed Description Cancer patients often experience anemia due to the disease itself, chemotherapy or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week randomized, double-blind, placebo-controlled, multicenter study (with an open-label extension) to assess the effectiveness of treatment with epoetin alfa in reducing the need for red cell transfusion by improving anemia in patients with multiple myeloma whose hemoglobin is less than 11 grams per deciliter. There will be 4 groups of patients in the study. Patients will first be placed into 2 groups according to whether or not they received at least 1 blood transfusion within the previous 3 months. Within each of these 2 groups, patients will then be randomly assigned to receive either epoetin alfa or placebo for 12 weeks. Dosing is initiated at 150 units per kilogram (U/kg) injected under the skin 3 times weekly for 4 weeks, then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. All patients who complete the 12-week double-blind period will be eligible to continue receiving epoetin alfa for an additional 12 weeks in an open-label extension of the study. The primary measures of effectiveness will be determined by the number of units of blood transfused, the proportion of patients requiring transfusion, and the number of units transfused relative to whether or not they received transfusions before the study. Additional effectiveness measures include the number of patients whose hemoglobin level reach at least 12 grams per deciliter (anemia considered "corrected") or who have an increase in hemoglobin of at least 2 grams per deciliter, and the change in the percentage of red blood cells and number of developing red blood cells in the blood. Changes in quality-of-life (Nottingham and visual analog scale) and performance scores will also be measured. Safety evaluations (incidence of adverse events, laboratory tests, and vital signs) and changes in underlying multiple myeloma will be assessed. The hypothesis of the study is that epoetin alfa will be superior to placebo in reducing the need for transfusions and improving anemia and quality of life. Double-blind: Epoetin alfa 150 units per kilogram (U/kg) injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label: dose to maintain target hemoglobin range.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Multiple Myeloma
Intervention  ICMJE Drug: epoetin alfa
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2011)
156
Original Enrollment  ICMJE
 (submitted: December 22, 2005)
134
Actual Study Completion Date  ICMJE September 1996
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with documented multiple myeloma defined by standard criteria, with at least 6 months having elapsed since beginning chemotherapy
  • having a self-care performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a score ranging from 0 [fully active, no disease restriction] to 3 [capable of only limited self-care, confined to bed or chair more than 50% of waking hours])
  • having a life expectancy of at least 3 months
  • having a baseline hemoglobin <11 g/dL and baseline count of <100,000 microliter for developing red cells
  • with an ability to administer self-injections

Exclusion Criteria:

  • Patients having clinically significant disease other than cancer
  • having evidence of uncontrolled hypertension or a history of seizure
  • having untreated iron, folate, or Vitamin B12 deficiency
  • receiving a transfusion within 7 days of study entry, or androgen therapy within 1 month of study entry
  • receiving dialysis at baseline screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00270101
Other Study ID Numbers  ICMJE CR005911
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP