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

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