AMD3100-2105: Mobilization of Stem Cells With AMD3100 and G-CSF in Non-Hodgkin’s Lymphoma and Multiple Myeloma Patients

This study has been completed.

Sponsored By:	Genzyme AnorMED Corporation, a wholly owned subsidiary of Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00322491

Purpose

The purpose of this protocol is to evaluate an interval of 10-11 hours between dosing with AMD3100 and the beginning of apheresis to determine if there will be at least a 2-fold increase in circulating CD34+ cells. Data from this protocol will assist in the determination of the dosing schedule for future studies.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin Multiple Myeloma	Drug: AMD3100 Drug: G-CSF Procedure: Stem cell mobilization Procedure: Apheresis Procedure: Autologous transplantation	Phase II

Study Type: Interventional

Study Design: Treatment, Non-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 plus AMD3100 exhibit ≥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 OD) plus AMD3100 and transplanted with ≥ 5 × 10^6 cells/kg will engraft PMNs by day 12, but no later than day 21.

Expected Total Enrollment: 49

Study Start: 2004-03; Study Completion: 2006-06

Patients with Non-Hodgkin’s lymphoma and Multiple Myeloma 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 day prior to apheresis. Patients will undergo mobilization with G-CSF (10 mcg/kg QD) and in the evening prior to apheresis will receive AMD3100 (240 mcg/kg). Patients will receive G-CSF (10 mcg/kg QD) in the morning followed by apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem cells. The target number of cells to collect is ≥ 5 x 10^6 CD34+ stem cells/kg whether a single transplant or a tandem transplant is planned. Patients will be transplanted with cells obtained from the G-CSF and AMD3100 mobilization regimen. The number of CD34+ cells mobilized in the peripheral blood 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 10^6 CD34+ cells will also be measured. Finally, success of the transplantation(s) will be evaluated by the time to engraftment of poly morphonuclear leukocytes as the primary measurement and platelets as the secondary measurement. Patients will be followed for durability of their transplant for 12 months following transplantation.

Eligibility

Ages Eligible for Study: 18 Years - 70 Years

Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Diagnosis of NHL or MM eligible for autologous transplantation

No more than 3 prior regimens of chemotherapy

ECOG performance status of 0 or 1

WBC >3.0 × 109/L

Absolute PMN count >1.5 × 109/L

PLT count >100 × 109/L

Exclusion Criteria

Patients who have failed previous collections

Brain metastases or carcinomatous meningitis

History of ventricular arrhythmias

History of paresthesias

More Information

Study ID Numbers: AMD3100-2105
ClinicalTrials.gov Identifier: NCT00322491
Health Authority: United States: Food and Drug Administration