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Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

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ClinicalTrials.gov Identifier: NCT01095757
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : September 12, 2014
Last Update Posted : September 29, 2014
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Edmund Waller, Emory University

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE March 30, 2010
Results First Submitted Date  ICMJE October 22, 2013
Results First Posted Date  ICMJE September 12, 2014
Last Update Posted Date September 29, 2014
Study Start Date  ICMJE March 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
  • Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
  • Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Proportion of patients achieving the target number of either 5 x 106 (lymphoma) or 10 x 106 (myeloma) of CD34+ cells/kg in a single day of apheresis [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Total numbers of CD34+ cells/kg collected, mean numbers of days of apheresis needed to collect the target numbers of CD34+ cells/kg , neutrophil and platelet engraftment and graft durability at 12 months post transplant [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
Official Title  ICMJE Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
Brief Summary

The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.

The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myeloma
  • Lymphoma
Intervention  ICMJE Drug: Plerixafor
240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Other Names:
  • Mozobil
  • AMD3100
Study Arms  ICMJE Plerixafor + Chemo and G-CSF
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Intervention: Drug: Plerixafor
Publications *

*   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: September 16, 2014)
45
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2010)
40
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-70 years
  2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Up to 3 prior treatment regimens
  5. Meet all eligibility requirements for autologous transplant
  6. Adequate marrow function defined as white blood cells (WBC) >3,000; ANC >1,500/mm3; platelets >75,000/mm3
  7. Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
  8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin < 2 times upper limit of normal
  9. Able to provide informed consent
  10. Women not pregnant and agree to use contraception

Exclusion Criteria:

  1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
  2. Brain metastases or carcinomatous meningitis
  3. Previous treatment with high dose chemotherapy and autologous transplant
  4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
  5. Acute infection or unexplained fever >38°C
  6. Weight > 175% of ideal body weight as defined by the Devine equation
  7. Experimental therapy within 4 weeks
  8. Cytokine administration in the previous 14 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01095757
Other Study ID Numbers  ICMJE IRB00027735
WCI1671-09 ( Other Identifier: Other )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edmund Waller, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Genzyme, a Sanofi Company
Investigators  ICMJE
Principal Investigator: Edmund Waller, MD, PhD Emory University Winship Cancer Institute
PRS Account Emory University
Verification Date September 2014

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