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Mobilization of Stem Cells With AMD3100, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
This study has been completed.
Sponsors and Collaborators: Genzyme
AnorMED
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00322387
  Purpose

Patients with Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus AMD3100. The purpose of this protocol is to determine if, in patients with MM or NHL, AMD3100 added to a chemotherapy and G CSF mobilization regimen can increase the circulating levels of PBSCs by ≥ 2-fold which would be removed by apheresis and to evaluate the success of the transplant by measuring the time to engraftment of PMNs and PLTs.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Multiple Myeloma
Drug: AMD3100
Drug: G-CSF (Neupogen)
Procedure: Stem cell mobilization
Procedure: Apheresis
Procedure: Autologous transplantation
Phase II

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

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • To determine if AMD3100 given after chemo mobilization and G-CSF is generally safe and well tolerated.

Secondary Outcome Measures:
  • To determine if MM and NHL patients mobilized with chemotherapy and G-CSF plus AMD3100 exhibit ≥ 2-fold increase in circulating CD34+ cells.(This will increase the yield during apheresis.)
  • To determine if MM and NHL patients who are mobilized with G-CSF plus AMD3100 and transplanted with the apheresed cells achieve PMN engraftment by study day 12, but no later than study day 21.

Enrollment: 44
Study Start Date: January 2004
Study Completion Date: June 2006
Detailed Description:

This is an open label, multi-center, Phase 2 study. Patients with MM or NHL who are to be treated with PBSC autologous transplantation are eligible for this protocol. The only change to the standard of care is the addition of AMD3100 to a mobilization regimen of chemotherapy and G-CSF. Patients will first be given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis will be performed. After the first apheresis, AMD3100 will be given at 10PM, 10 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the AMD3100 dose and the start of apheresis will be measured. The apheresis yields on day one and day two will be compared.

  Eligibility

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

Inclusion Criteria:

  • MM in first partial response/complete response, first relapse, or second partial/complete response
  • NHL in first or second partial or complete remission
  • NHL patients who do not have bone marrow involvement and < 10% for follicular involvement
  • MM patients who have stable disease with < 40% bone marrow involvement
  • No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
  • ECOG performance status of 0 or 1
  • WBC >3.0 x 10^9/L
  • Absolute neutrophil count >1.5 x 10^9/L
  • Platelet count >100 x 10^9/L

Exclusion Criteria:

  • Brain metastases or carcinomatous meningitis
  • Hypercalcaemia (>1 mg/dl above the ULN)
  • Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
  • Acute Infection
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study ID Numbers: AMD3100-2104
Study First Received: May 4, 2006
Last Updated: December 14, 2007
ClinicalTrials.gov Identifier: NCT00322387  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme:
Non-Hodgkin's Lymphoma
Multiple Myeloma
Stem cell mobilization

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