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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

Phase 3
18 Years
78 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

A peripheral stem cell transplant may be able to replace blood-forming cells that were
destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is
used to cause the growth and mobilization of stem cells from bone marrow to peripheral
blood, which can then be collected from the peripheral blood by a process called apheresis.
Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral
blood, possibly allowing for a more rapid collection of a larger number of stem cells from
the peripheral blood. Larger stem cell doses for transplantation correlate to faster
recovery times after high dose chemotherapy followed with stem cell transplantation. This
study is intended to determine whether the combination of plerixafor with filgrastim
(G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect
at least 6 million stem cells in two or less apheresis sessions.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Inclusion Criteria:

- Diagnosis of multiple myeloma in first or second complete or partial remission

- >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade
were not considered prior chemotherapy for the purpose of this study)

- Recovered from all acute toxic effects of prior chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- White Blood Cell count (WBC) > 2.5*10^9/L

- Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L

- Platelet (PLT) > 100*10^9/L

- Serum creatinine <=2.2 mg/dL

- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation

- Negative for HIV

Exclusion Criteria):

- Failed previous stem cell collection

- Previous stem cell transplantation

- Brain metastases or myelomatous meningitis

- Radiation to ≥ 50% of the pelvis

- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or
other conduction abnormality

- Received bone-seeking radionuclides (e.g. holmium)

- A residual acute medical condition resulting from prior chemotherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.

Outcome Description:

Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.

Outcome Time Frame:

up to Day 6

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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