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AMD3100 Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF
This study has been completed.
Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00396266
  Purpose

Patients with Non-Hodgkin's Lymphoma (NHL) and Multiple Myeloma (MM) who have undergone a cyto-reductive chemotherapy regimen protocol, who are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of AMD3100 to a G-CSF mobilization regimen on the evening prior to apheresis. Patients will undergo mobilization with G-CSF and on each evening prior to apheresis will receive AMD3100. Patients will receive G-CSF in the morning followed by apheresis for up to 5 consecutive days in order to collect the target number of (≥5 x 10e6) CD34+ stem cells. All patients will be treated with high dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF and AMD3100 mobilization regimen. Patients will be followed for durability of their transplant for 12 months following transplantation.


Condition Intervention Phase
Multiple Myeloma
Non-Hodgkin's Lymphoma
Drug: AMD3100
Procedure: Stem Cell Mobilization
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Lymphoma Multiple Myeloma
Drug Information available for: Granulocyte colony-stimulating factor JM 3100
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Treatment With AMD3100 in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients to Increase the Number of Peripheral Blood Stem Cells When Given a Mobilizing Regimen of G-CSF

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • To determine if AMD3100 is generally safe.

Secondary Outcome Measures:
  • To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus AMD3100 will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of AMD3100.
  • To determine if NHL and MM patients who are mobilized with G-CSF (10 µg/kg QD) plus AMD3100 and transplanted with ≥5 x 10e6 cells/kg will engraft PMNs by day 12, but no later than day 21.
  • To determine if NHL tumor cells are mobilized after either G-CSF mobilization or AMD3100 administration.
  • To examine the pharmacokinetics and pharmacodynamics of a single dose of 240 µg/kg AMD3100 administered after 4 days of G-CSF mobilization in NHL and MM patients.

Enrollment: 23
Study Start Date: January 2005
Study Completion Date: December 2007
Detailed Description:

Patients with Non-Hodgkin's Lymphoma (NHL) and Multiple Myeloma (MM) who have undergone a cyto-reductive chemotherapy regimen protocol, who are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of AMD3100 to a G-CSF mobilization regimen on the evening prior to apheresis. Patients will undergo mobilization with G-CSF (10 µg/kg QD) and on each evening prior to apheresis will receive AMD3100 (240 µg/kg). Patients will receive G-CSF(10 µg/kg QD) in the morning followed by apheresis for up to 5 consecutive days in order to collect the target number of (≥5 x 10e6) CD34+ stem cells. All patients will be treated with high dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF and AMD3100 mobilization regimen. Patients will be followed for durability of their transplant for 12 months following transplantation. In the event that a sufficient number of cells for transplantation are not obtained from the collection, cells may be retained and pooled for transplantation at the Investigator's discretion. The number of CD34+ cells mobilized in the peripheral blood (PB) from the time of the AMD3100 dose to just prior to apheresis and those harvested in the apheresis product will be measured. The number of apheresis sessions required to obtain ≥5 x 10e6 CD34+ cells/kg will also be measured. In addition, the mobilization of NHL tumor cells and the pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of AMD3100 will be examined. Finally, success of the transplantation will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMNs) as the primary measurement and platelets (PLTs) as the secondary measurement.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 70 years
  • Diagnosis of NHL or MM eligible for autologous transplantation
  • No more than 3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy)
  • >4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study.)
  • ECOG performance status of 0 or 1
  • The patient has recovered from all acute toxic effects of prior chemotherapy
  • WBC >3.0 x 10e9/L
  • Absolute PMN count > 1.5 x 10e9/L
  • PLT count >100 x 10e9/L
  • Serum creatinine ≤2.2 mg/dL
  • SGOT, SGPT and total bilirubin <2 x upper limit of normal (ULN)
  • Left ventricle ejection fraction >45% (by normal ECHO or MUGA scan)
  • FEV₁>60% of predicted or DLCO >45% of predicted
  • Negative for HIV
  • Signed informed consent
  • Women of child bearing potential agree to use an approved form of contraception

Exclusion Criteria:

  • A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
  • Patients who have failed previous collections
  • A residual acute medical condition resulting from prior chemotherapy
  • Brain metastases or carcinomatous meningitis
  • Acute infection
  • Fever (temp> 38°C/100.4°F)
  • Positive pregnancy test in female patients
  • Lactating females
  • Patients of child-bearing potential unwilling to implement adequate birth control
  • Patients whose actual body weight exceeds 150% of their ideal body weight
  • History of ventricular arrhythmias
  • History of paresthesias
  • Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase
  • Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396266

Locations
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver General Hospital, BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E3
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor, MD Genzyme
  More Information

Responsible Party: Genzyme ( Medical Monitor )
Study ID Numbers: AMD3100-C201
Study First Received: November 2, 2006
Last Updated: May 16, 2008
ClinicalTrials.gov Identifier: NCT00396266  
Health Authority: Canada: Health Canada

Keywords provided by Genzyme:
Non-Hodgkin's Lymphoma
Multiple Myeloma
stem cell mobilization
AMD3100
autologous transplantation

Study placed in the following topic categories:
Immunoproliferative Disorders
JM 3100
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Lymphoma, small cleaved-cell, diffuse
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Lymphatic Diseases
Hemorrhagic Disorders
Multiple myeloma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Histologic Type
Anti-Retroviral Agents
Immune System Diseases
Therapeutic Uses
Cardiovascular Diseases
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009