CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
G-CSF Plus Plerixafordrug
Likely dose
G-CSF 10 µg/kg/day subcutaneously for 4 days, followed by plerixafor 240 µg/kg subcutaneously on evening of Day 4AI-extracted
Key inclusion· 6
  • ✓Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) eligible for autologous transplantation
  • ✓No more than 3 prior regimens of chemotherapy
  • ✓More than 4 weeks since last cycle of chemotherapy with full recovery from acute toxicity
  • ✓ECOG performance status 0 or 1
Key exclusion· 8
  • ✕Previous failed stem cell collections
  • ✕Brain metastases or carcinomatous meningitis
  • ✕History of ventricular arrhythmias
  • ✕History of paresthesias

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00322842
NCT00322842Phase 2Completed
CompareCT.gov

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

Genzyme, a Sanofi Company·interventional·Posted May 8, 2006·Updated Mar 13, 2014

In Brief

A Phase 2 clinical trial evaluating G-CSF Plus Plerixafor for Lymphoma, Non-Hodgkin and Multiple Myeloma. Completed, enrolled 35 participants across 3 sites.

Detailed Summary

This study evaluates the safety of plerixafor and other outcomes that are purely exploratory in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between dosing with plerixafor 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Non-Hodgkin, Multiple Myeloma
CountriesGermany
CollaboratorsAnorMED

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2006
Enrollment StartSep 1, 2004
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.2 years ago

Interventions

G-CSF Plus Plerixafordrug

Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.