Multiple Myeloma Clinical Trial
Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide
Summary
This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
Full Description
PRIMARY OBJECTIVES:
I. Ability to reach target collection of 5 x 10^6 CD34+ cells/Kg with =< 2 days of leukaphereses using one of two mobilization regimens.
SECONDARY OBJECTIVES:
I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =< 5 days of leukaphereses.
II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.
III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8.
ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7.
After completion of study treatment, patients are followed up at 14 days.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of MM by International Myeloma Working Group Criteria
In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood & Marrow Transplant Research
Received at least 2 cycles of lenalidomide therapy
Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT)
At least 2 weeks since last exposure to lenalidomide
Eastern Cooperative Oncology Group performance status of 0 or 1
Prior to the start of mobilization:
white blood cell count >/= 2.5 x 10^9/L
absolute neutrophil count >/= 1.2 x 10^9/L
platelet count >/=100 x 10^9/L
creatinine clearance >/= 30mL/minute
If childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy
Exclusion Criteria:
Had prior autologous or allogeneic transplantation
Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization
Failed previous hematopoietic stem cell collections or collection attempts
Received radiation therapy to the pelvic area
Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization
Had received experimental therapy within 4 weeks of enrolling in study
Current or prior history of other malignancies, excluding basal cell carcinoma of the skin
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There are 2 Locations for this study
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
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