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Phase II Trial of Intravenously Administered AMD3100 (Plerixafor) for Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Following a Lenalidomide Based Initial Therapy

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma, Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

Phase II Trial of Intravenously Administered AMD3100 (Plerixafor) for Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Following a Lenalidomide Based Initial Therapy

Primary Objective: I. To determine the proportion of patients reaching a stem cell yield of
3 million CD34 cells/kg by second day of apheresis with intravenously administered AMD3100
among patients receiving primary therapy for myeloma with lenalidomide. Secondary
Objectives: I. Safety and tolerability of intravenously administered AMD3100. II. Rate of
failure to mobilize. Outline: Patients receive plerixafor IV on days 5-8 and filgrastim
subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days.

Inclusion Criteria

Inclusion - Absolute neutrophil count >= 1000/uL - Platelet >= 75000/uL -
Hemoglobin >= 8.0 g/dL - Serum aspartate aminotransferase (AST)/serum glutamic
oxaloacetic transaminase (SGOT), serum alanine aminotransferase (ALT)/serum glutamic
pyruvic transaminase (SGPT) and total bilirubin < 2 x upper limit of normal (ULN) -
Confirmed diagnosis of multiple myeloma, requiring therapy - Initial treatment for
symptomatic myeloma using a lenalidomide based treatment regimen, started =< 12 months
prior to registration - Received at least 2 cycles of treatment with the lenalidomide
regimen - Last dose of lenalidomide > 2 weeks prior to registration - Eligible
to undergo autologous transplantation - ECOG performance status (PS) 0 or 1 -
Willingness to return for follow-up - Provide informed written consent -
Adequate cardiopulmonary function: ejection fraction >= 45%, corrected pulmonary diffusion
capacity of >= 50%, FEV1 >= 50%, FVC >= 50% - Negative serum or urine pregnancy test
done =< 7 days prior to registration, for women of childbearing potential only Exclusion
- A co-morbid condition which, in the view of the Investigators, renders the patient
at high risk from treatment complications - Active malignancy with the exception of
non melanoma skin cancer or in situ cervical or breast cancer - Other co-morbidity
which would interfere with patient's ability to participate in the trial, e.g.
uncontrolled infection, uncompensated heart or lung disease - Other concurrent
chemotherapy, radiotherapy, or any ancillary therapy considered investigational - Use
of cyclophosphamide as part of stem cell mobilization - Use of more than one regimen
for treatment of symptomatic myeloma - Dialysis dependent renal failure -
Pregnant women or women of reproductive ability who are unwilling to use effective
contraception - Nursing women - Men who are unwilling to use a condom (even if
they have undergone a prior vasectomy) while having intercourse with any woman, while
taking the drug and for 4 weeks after stopping treatment - Acute infection, active
HIV infection

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis

Outcome Description:

Number of CD34 cells/kg collected on days 1-2. Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.

Outcome Time Frame:

After 2 days of apheresis

Safety Issue:


Principal Investigator

Shaji Kumar, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Multiple Myeloma
  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Mayo Clinic Rochester, Minnesota  55905
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404