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

Phase 3

Terminated

Brief 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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm I	filgrastim	Patients receive G-CSF SC QD on days 1-4.
Arm II	plerixafor	Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
Arm II	filgrastim	Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.

Primary Outcome Measures

Name	Time	Method
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg	In =< 2 days of leukaphereses

Secondary Outcome Measures

Name	Time	Method
Compare Days of Apheresis Between Mobilization Groups	Day 1	Using the Wilcoxon Rand Sum Test
Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other	By day 1	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.
Compare Need for Remobilization Between Mobilization Groups	Day 1	Using the Chi-square test or Fisher's exact test, as appropriate.
Percentage of Patients Achieving Target Goal CD34+ Cells Dose	In =< 5 days of leukaphereses
Compare Need for Hospitalization During Mobilization Between Mobilization Groups	Day 1

Locations (2): Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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Cleveland, Ohio, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Cleveland, Ohio, United States