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 non-Hodgkin's lymphoma and multiple myeloma who have undergone prior
cyto-reductive chemotherapy and are to be autologously transplanted will be treated with a
combination of plerixafor and granulocyte colony-stimulating factor (G-CSF) mobilization
regimen on the day prior to apheresis. The only change to standard of European care is the
addition of plerixafor to a G-CSF mobilizing regimen. Participants will undergo mobilization
with G-CSF (10 µg/kg each day) and on each day prior to apheresis will receive plerixafor
(240 µg/kg). Participants will undergo apheresis for up to 5 consecutive days in order to
collect the target number of (≥ 5*10^6) CD34+ stem cells/kg. Participants will be
transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The
number of CD34+ cells mobilized in the peripheral blood from the time of the plerixafor dose
to just prior to apheresis and those harvested in the apheresis product will be measured.
The number of apheresis sessions required to obtain ≥ 5*10^6 CD34+ cells/kg will also be
measured. Success of the transplantation(s) will be evaluated by the time to engraftment of
poly-morphonuclear 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
- Negative for human immunodeficiency virus (HIV)
- Women of child bearing potential who 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
- History of paresthesias
- 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
- 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 step 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:
Germany:Bundesinstitut für Arzneimittel und Medizinprodukte
Study ID:
AMD3100-EU21
NCT ID:
NCT00322842
Start Date:
September 2004
Completion Date:
February 2007
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
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