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
18 Years
70 Years
Both
Multiple Myeloma, Lymphoma, Non-Hodgkin
Trial Information
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
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 only change to the standard of care is the addition of plerixafor to a
granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to
apheresis. Participants will undergo mobilization with G-CSF (10 mcg/kg each day) and will
receive plerixafor (240 mcg/kg) in the evening prior to apheresis. Participants will undergo
apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem
cells (≥ 5*10^6 CD34+ cells/kg for either single or tandem transplant). After apheresis, all
participants will be treated with high-dose chemotherapy in preparation for transplantation.
Participants will be transplanted with cells obtained from the G-CSF and plerixafor
mobilization regimen. The increase in CD34+ cells in the peripheral blood from the time of
the plerixafor dose to just prior to apheresis and the number of CD34+ cells in the
apheresis product will be measured. Success of the transplantation(s) will be evaluated by
the time to engraftment of polymorphonuclear leukocytes (PMN). A subpopulation will have
pharmacokinetic and pharmacodynamic analysis done.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Inclusion Criteria:
- 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 Criteria:
- • 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 150% of their ideal body weight
- History of paresthesias (at least Grade 2)
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)
Outcome Description:
Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Outcome Time Frame:
Day 1 to approximately Day 38 (before start of chemotherapy)
Safety Issue:
Yes
Principal Investigator
Medical Monitor, MD
Investigator Role:
Study Director
Investigator Affiliation:
Genzyme
Authority:
Canada: Health Canada
Study ID:
AMD3100-C201
NCT ID:
NCT00396266
Start Date:
January 2005
Completion Date:
December 2007
Related Keywords:
- Multiple Myeloma
- Lymphoma, Non-Hodgkin
- Non-Hodgkin's Lymphoma
- Multiple Myeloma
- stem cell mobilization
- AMD3100
- autologous transplantation
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
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