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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Emory University
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 18, 2012
Last verified: September 2012
  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:
  • 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF vs. a historical group of control patients who received chemotherapy and G-CSF alone.
Drug: Plerixafor
240 µg/kg subcutaneous injection on the day that the 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

Detailed Description:

Study is ongoing; no interim analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70 years
  2. MM or NHL patients in first or second complete or partial remission
  3. 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 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 AST/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-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

Contacts
Contact: Edmund Waller, MD, PhD 1-888-946-7447 ewaller@emory.edu

Locations
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, MD, PhD    888-946-7447    ewaller@emory.edu   
Sponsors and Collaborators
Emory University
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Edmund Waller, MD, PhD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Edmund Waller, MD, Emory University
ClinicalTrials.gov Identifier: NCT01095757     History of Changes
Other Study ID Numbers: WCI1671-09
Study First Received: March 26, 2010
Last Updated: September 18, 2012
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
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014