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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Refractory Multiple Myeloma

Intervention / Treatment
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* Drug: plerixafor
* Biological: filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I<br>Patients receive G-CSF SC QD on days 1-4. | Biological: filgrastim<br>* Given SC<br>* Other names: Neupogen;|
| Experimental: Arm II<br>Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. | Drug: plerixafor<br>* Given SC<br>* Other names: Mozobil;Biological: filgrastim<br>* Given SC<br>* Other names: Neupogen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg |  | In =< 2 days of leukaphereses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Achieving Target Goal CD34+ Cells Dose |  | In =< 5 days of leukaphereses | 
| Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other | Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm. | By day 1 | 
| Compare Days of Apheresis Between Mobilization Groups | Using the Wilcoxon Rand Sum Test | Day 1 | 
| Compare Need for Hospitalization During Mobilization Between Mobilization Groups |  | Day 1 | 
| Compare Need for Remobilization Between Mobilization Groups | Using the Chi-square test or Fisher's exact test, as appropriate. | Day 1 |