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NCT Number: NCT01095757

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

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.

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Key information

Conditions

Myeloma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
  • Brain metastases or carcinomatous meningitis
  • Previous treatment with high dose chemotherapy and autologous transplant
  • Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
  • Acute infection or unexplained fever >38°C
  • Weight > 175% of ideal body weight as defined by the Devine equation
  • Experimental therapy within 4 weeks
  • Cytokine administration in the previous 14 days

Treatment and study plan

plerixafor

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Mar 30, 2010
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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