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Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM).

NCT00665314 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-02-11

No results posted yet for this study

Summary

Some patients with multiple myeloma or lymphoma will need treatment with high dose chemotherapy to treat their condition. This potent treatment will kill many of the blood-forming cells in the bone marrow. The patient will therefore need these blood-forming cells replaced after the chemotherapy treatment. This is done by collecting some of teh patients own blood-forming stem cells before chemotherapy, storing them and then infusing them into the patient after chemotherapy (in the same way as a blood transfusion is given). The stem cells will then make their way unto the bone marrow and re-populate it. Having stem cells collected and returned later is called an "Autologous Transplant".

In most patients these blood-forming stem cells (which normally live in the bone marrow) are "mobilized" into the blood stream where they are then collected by a process called apheresis (a bit like donating blood). This process of mobilization is not always successful. In this study patients who did not collect enough stem cells in a previous cell collection attempt to have an autologous stem cell transplant will participate. Patients will be mobilized with G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100.

AMD3100 is a member of a new class of medications called "chemokine inhibitors". The drug triggers the movement of stem cells out of the bone marrow into the blood stream. In previous studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in combination, a greater number of stem cells were mobilized into the blood stream than by using g-CSF alone.

The purposes of this study are to measure how many stem cells can be collected, the number of days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study will also evaluate how well the cells grow when transplanted.

Conditions

Interventions

DRUG

Plerixafor (AMD3100)

0.24mg/kg SC for 2 to 7 days.

DRUG

Can be any registered nonpegylated form of G-CSF

10mcg/kg SC for 4 days followed by an additional 2 to 7 days.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-04-30
Completion
2009-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665314 on ClinicalTrials.gov