Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 to 70 Pharmaceutical / Industry AMD3100-C201 NCT00396266

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Genzyme Corporation

Medical Monitor, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00396266
Information obtained from ClinicalTrials.gov on May 27, 2008