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

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Edmund Waller, Emory University
ClinicalTrials.gov Identifier:
NCT01095757
First received: March 26, 2010
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Myeloma
Lymphoma
Drug: Plerixafor
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg [ Time Frame: Within the first 4 days following the first dose of Plerixafor ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: March 2010
Study Completion Date: February 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: NCT01095757

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

Publications:

Responsible Party: Edmund Waller, MD, Emory University
ClinicalTrials.gov Identifier: NCT01095757     History of Changes
Other Study ID Numbers: IRB00027735, WCI1671-09
Study First Received: March 26, 2010
Results First Received: October 22, 2013
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board
United States: Emory Winship data Safety Monitoring Committee

Keywords provided by Emory University:
Myeloma
Lymphoma
Stem cell transplantation

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014