AMD31002104: Mobilization of Stem Cells With AMD3100, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin’s Lymphoma Patients

This study has been completed.

Sponsored By:	Genzyme AnorMED Corporation, a wholly owned subsidiary of Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00322387

Purpose

Patients with Multiple Myeloma (MM) and Non-Hodgkin’s Lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus AMD3100. The purpose of this protocol is to determine if, in patients with MM or NHL, AMD3100 added to a chemotherapy and G CSF mobilization regimen can increase the circulating levels of PBSCs by ≥ 2-fold which would be removed by apheresis and to evaluate the success of the transplant by measuring the time to engraftment of PMNs and PLTs.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin Multiple Myeloma	Drug: AMD3100 Drug: G-CSF (Neupogen) 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 Multiple Myeloma or Non-Hodgkin’s Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF

Further Study Details:

Primary Outcomes: To determine if AMD3100 given after chemo mobilization and G-CSF is generally safe and well tolerated.

Secondary Outcomes: To determine if MM and NHL patients mobilized with chemotherapy and G-CSF plus AMD3100 exhibit ≥ 2-fold increase in circulating CD34+ cells.(This will increase the yield during apheresis.); To determine if MM and NHL patients who are mobilized with G-CSF plus AMD3100 and transplanted with the apheresed cells achieve PMN engraftment by study day 12, but no later than study day 21.

Expected Total Enrollment: 44

Study Start: 2004-01; Study Completion: 2006-06

This is an open label, multi-center, Phase 2 study. Patients with MM or NHL who are to be treated with PBSC autologous transplantation are eligible for this protocol. The only change to the standard of care is the addition of AMD3100 to a mobilization regimen of chemotherapy and G-CSF. Patients will first be given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis will be performed. After the first apheresis, AMD3100 will be given at 10PM, 10 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient’s peripheral CD34+ cell count between the AMD3100 dose and the start of apheresis will be measured. The apheresis yields on day one and day two will be compared.

Eligibility

Ages Eligible for Study: 18 Years - 70 Years

Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

MM in first partial response/complete response, first relapse, or second partial/complete response

NHL in first or second partial or complete remission

NHL patients who do not have bone marrow involvement and < 10% for follicular involvement

MM patients who have stable disease with < 40% bone marrow involvement

No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)

ECOG performance status of 0 or 1

WBC >3.0 x 10^9/L

Absolute neutrophil count >1.5 x 10^9/L

Platelet count >100 x 10^9/L

Exclusion Criteria

Brain metastases or carcinomatous meningitis

Hypercalcaemia (>1 mg/dl above the ULN)

Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias

Acute Infection

More Information

Study ID Numbers AMD31002104
ClinicalTrials.gov Identifier NCT00322387
Health Authority: United States: Food and Drug Administration