AMD3100EU21: Treatment With AMD3100 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:	NCT00322842

Purpose

The purpose of this study is to determine whether the combination of AMD3100 and G-CSF mobilizes and collects sufficient number of stem cells in Non-Hodgkin’s lymphoma and Multiple Myeloma patients for autologous transplantation and to evaluate success of the transplantation.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin Multiple Myeloma	Drug: AMD 3100 Drug: G-CSF Procedure: stem cells 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 QD) plus AMD3100 and transplanted with ≥ 2 × 10^6 cells/kg body weight will engraft PMNs by day 14, but no later than day 21.; To determine the increase in CD34+ cell mobilization from steady state hematopoiesis to pre-leukapheresis sample in G-CSF plus AMD3100 treated patients compared to historical controls treated with G-CSF alone or chemotherapy and G-CSF.

Expected Total Enrollment: 35

Study Start: 2004-10; Study Completion: 2007-02

Patients with Non-Hodgkin’s lymphoma and Multiple Myeloma who have undergone a cyto-reductive chemotherapy regimen protocol and who are to be autologously transplanted will be treated with a combination of AMD3100 and G-CSF mobilization regimen on the day prior to apheresis. The only change to standard of care is the addition of AMD 3100 to a G-CSF mobilizing regiment. Patients will undergo mobilization with G-CSF (10 µg/kg QD) and on each day prior to apheresis will receive AMD3100 (240 µg/kg). Patients will undergo apheresis for up to 5 consecutive days in order to collect the target number of (≥ 5 × 10^6) CD34+ stem cells/kg. 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 × 10^6 CD34+ cells/kg will also be measured. Finally, success of the transplantation will be evaluated by the time to engraftment of polymorphonuclear leukocytes as the primary measurement and platelets as the secondary measurement. Patients will be followed for durability of their transplant for 1 year following transplant.

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 × 10^9/L

Absolute PMN count >1.5 × 10^9/L

PLT count >100 × 10^9/L

Exclusion Criteria

Patients who have failed previous collections

Brain metastases or carcinomatous meningitis

History of ventricular arrhythmias

More Information

Study ID Numbers: AMD3100-EU21
ClinicalTrials.gov Identifier: NCT00322842
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte