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AMD3100C201: AMD3100 Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF

This study is ongoing, but not recruiting participants.

Sponsored By:

Genzyme
AnorMED Corporation, a wholly owned subsidiary of Genzyme

Information Provided By:

Genzyme

ClinicalTrials.gov Identifier:

NCT00396266

Purpose

Patients with Non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma (MM) who have undergone a cyto-reductive chemotherapy regimen protocol, who 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 AMD3100 to a G-CSF mobilization regimen on the evening prior to apheresis. Patients will undergo mobilization with G-CSF and on each evening prior to apheresis will receive AMD3100. Patients will receive G-CSF in the morning followed by apheresis for up to 5 consecutive days in order to collect the target number of (≧5 x 10e6) CD34+ stem cells. All patients will be treated with high dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF and AMD3100 mobilization regimen. Patients will be followed for durability of their transplant for 12 months following transplantation.

Condition

Intervention

Phase

Multiple Myeloma
Non-Hodgkin's Lymphoma

Drug: AMD3100
Procedure: Stem Cell Mobilization

Phase II

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: 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

Further Study Details:

Primary Outcomes: To determine if AMD3100 is generally safe.

Secondary Outcomes: To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus AMD3100 will have a ≧2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of AMD3100.; To determine if NHL and MM patients who are mobilized with G-CSF (10 µg/kg QD) plus AMD3100 and transplanted with ≧5 x 10e6 cells/kg will engraft PMNs by day 12, but no later than day 21.; To determine if NHL tumor cells are mobilized after either G-CSF mobilization or AMD3100 administration.; To examine the pharmacokinetics and pharmacodynamics of a single dose of 240 µg/kg AMD3100 administered after 4 days of G-CSF mobilization in NHL and MM patients.

Total Enrollment: 23

Study Start: 2005-01

Patients with Non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma (MM) who have undergone a cyto-reductive chemotherapy regimen protocol, who 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 AMD3100 to a G-CSF mobilization regimen on the evening prior to apheresis. Patients will undergo mobilization with G-CSF (10 µg/kg QD) and on each evening prior to apheresis will receive AMD3100 (240 µg/kg). Patients will receive G-CSF(10 µg/kg QD) in the morning followed by apheresis for up to 5 consecutive days in order to collect the target number of (≧5 x 10e6) CD34+ stem cells. All patients will be treated with high dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF and AMD3100 mobilization regimen. Patients will be followed for durability of their transplant for 12 months following transplantation. In the event that a sufficient number of cells for transplantation are not obtained from the collection, cells may be retained and pooled for transplantation at the Investigator’s discretion. The number of CD34+ cells mobilized in the peripheral blood (PB) from the time of the AMD3100 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 x 10e6 CD34+ cells/kg will also be measured. In addition, the mobilization of NHL tumor cells and the pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of AMD3100 will be examined. Finally, success of the transplantation will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMNs) as the primary measurement and platelets (PLTs) as the secondary measurement.

Eligibility

Ages Eligible for Study: 18 Years - 70 Years

Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Age 18 - 70 years

Diagnosis of NHL or MM eligible for autologous transplantation

No more than 3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy)

>4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study.)

ECOG performance status of 0 or 1

The patient has recovered from all acute toxic effects of prior chemotherapy

WBC >3.0 x 10e9/L

Absolute PMN count > 1.5 x 10e9/L

PLT count >100 x 10e9/L

Serum creatinine ≦2.2 mg/dL

SGOT, SGPT and total bilirubin <2 x upper limit of normal (ULN)

Left ventricle ejection fraction >45% (by normal ECHO or MUGA scan)

FEV₁>60% of predicted or DLCO >45% of predicted

Negative for HIV

Signed informed consent

Women of child bearing potential agree to use an approved form of contraception

Exclusion Criteria

A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications

Patients who have failed previous collections

A residual acute medical condition resulting from prior chemotherapy

Brain metastases or carcinomatous meningitis

Acute infection

Fever (temp> 38°C/100.4°F)

Positive pregnancy test in female patients

Lactating females

Patients of child-bearing potential unwilling to implement adequate birth control

Patients whose actual body weight exceeds 150% of their ideal body weight

History of ventricular arrhythmias

History of paresthesias

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

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.

Location and Contact Information

Canada, Alberta
Tom Baker Cancer Center, Calgary, Alberta, T2N 4N2, Canada; Recruiting

Canada, British Columbia
Vancouver General Hospital, BC Cancer Agency, Vancouver, British Columbia, V5Z 4E3, Canada; Recruiting

More Information

Study ID Numbers: AMD3100C201
ClinicalTrials.gov Identifier: NCT00396266
Health Authority: Canada: Health Canada


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