Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide

Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:19 - Any
Start Date:July 2011

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Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide

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


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.


I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =< 5 days of

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.

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
We found this trial at
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
Cleveland, OH
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-2273
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
Cleveland, OH
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