Status:
COMPLETED
Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
Lead Sponsor:
Genzyme, a Sanofi Company
Collaborating Sponsors:
AnorMED
Conditions:
Lymphoma, Non-Hodgkin
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous trans...
Detailed Description
Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The o...
Eligibility Criteria
Inclusion
- Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
- No more than 3 prior regimens of chemotherapy
- More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White blood cell (WBC) count \>3.0\*10\^9/L
- Absolute polymorphonuclear cells (PMN) count \>1.5\*10\^9/L
- Platelet (PLT) count \>100\*10\^9/L
- Serum creatinine \<=2.2 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 x upper limit of normal (ULN)
- Left ventricle ejection fraction \>45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
- Forced expiratory volume of the lung in the first second (FEV1) \>60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) \>45% of predicted
- Negative for human immunodeficiency virus (HIV) type 1
- Women of child bearing potential agreed to use an approved form of contraception.
Exclusion
- Patients who have failed previous collections
- Brain metastases or carcinomatous meningitis
- History of ventricular arrhythmias
- A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
- A residual acute medical condition resulting from prior chemotherapy
- Acute infection
- Fever (temp \>38°C/100.4°F)
- Patients whose actual body weight exceeds 175% of their ideal body weight
- Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
- Positive pregnancy test in female patients
- Lactating females
- Patients of child-bearing potential unwilling to implement adequate birth control.
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00322491
Start Date
March 1 2004
End Date
June 1 2006
Last Update
March 13 2014
Active Locations (8)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
2
UCLA School of Medicine
Loa Angeles, California, United States
3
Loyola University Medical Center
Maywood, Illinois, United States
4
University of Iowa
Iowa City, Iowa, United States