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
Lymphoma, Non-Hodgkin, Multiple Myeloma
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. The number of apheresis sessions required to obtain ≥
5*10^6 CD34+ cells will also be measured. Success of the transplantation(s) will be
evaluated by the time to engraftment of polymorphonuclear leukocytes (PMN) and platelets
(PLT). Participants will be followed for durability of their transplant for 12 months
following transplantation.
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 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-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 (approximately day 38). 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
Investigator Role:
Study Director
Investigator Affiliation:
Genzyme
Authority:
United States: Food and Drug Administration
Study ID:
AMD3100-2105
NCT ID:
NCT00322491
Start Date:
March 2004
Completion Date:
June 2006
Related Keywords:
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Non-Hodgkin's Lymphoma
- Multiple Myeloma
- Stem cell mobilization
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Iowa | Iowa City, Iowa 52242 |
| UCLA School of Medicine | Los Angeles, California 900121973 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
