Status:
TERMINATED
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Multiple Myeloma
Lymphoma, Non-Hodgkin's
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be ...
Detailed Description
A Phase 2, single-center, open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Abbreviated List):
- Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)
- Eligible for autologous transplantation
- \<=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- \>4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- Total dose of melphalan ≦200 mg
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
- White blood cell (WBC) count \>3.0\*10\^9/L prior to first dose of G-CSF
- Absolute polymorphonuclear leukocyte (PMN) count \>1.5\*10\^9/L prior to first dose of G-CSF
- Platelet (PLT) count \>100\*10\^9/L prior to first dose of granulocyte colony-stimulating factor (G-CSF)
- Serum creatinine ≥2.2 mg/dL
- SGOT, SGPT and total bilirubin \<2 times upper limit of normal (ULN)
- Negative for HIV
- CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with G-CSF alone
- Exclusion Criteria (Abbreviated List):
- A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
- Failed previous stem cell collection or collection attempts
- A residual acute medical condition resulting from prior chemotherapy
- Active brain metastases or carcinomatous meningitis
- Active infection requiring antibiotic treatment
- Received prior radio-immunotherapy with Zevalin or Bexxar
- Received bone-seeking radionuclides (e.g., holmium)
- Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
- History of ventricular arrhythmias, including electrocardiogram (ECG)-documented premature ventricular contractions (PVCs), during the last 3 years
- 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
- Had an apheresis yield \>1.3\*10\^6 CD34+ cells/kg on Day 5 (Applicable only to patients who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of 8-19 cells/µl inclusive).
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00395967
Start Date
April 1 2005
End Date
August 1 2006
Last Update
May 1 2015
Active Locations (1)
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1
Duke University Medical Center - Adult BMT Program
Durham, North Carolina, United States, 27705