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

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: 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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Myeloma Lymphoma Drug: Plerixafor Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
Study Start Date : March 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Plerixafor

Arms and Interventions
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Arm Intervention/treatment
Plerixafor + Chemo and G-CSF
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01095757


Locations
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United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Edmund Waller, MD, PhD Emory University Winship Cancer Institute
More Information
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Publications:

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Responsible Party: Edmund Waller, MD, Emory University
ClinicalTrials.gov Identifier: NCT01095757    
Other Study ID Numbers: IRB00027735
WCI1671-09 ( Other Identifier: Other )
First Posted: March 30, 2010    Key Record Dates
Results First Posted: September 12, 2014
Last Update Posted: September 29, 2014
Last Verified: September 2014
Keywords provided by Edmund Waller, Emory University:
Myeloma
Lymphoma
Stem cell transplantation
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Plerixafor
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents