Clinical trial NCT01301963: Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide
Official title: Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Refractory Multiple Myeloma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-02-23
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
timeFrame: In =< 2 days of leukaphereses
Secondary outcomes:
measure: Percentage of Patients Achieving Target Goal CD34+ Cells Dose
timeFrame: In =< 5 days of leukaphereses
measure: Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other
timeFrame: By day 1
measure: Compare Days of Apheresis Between Mobilization Groups
timeFrame: Day 1
measure: Compare Need for Hospitalization During Mobilization Between Mobilization Groups
timeFrame: Day 1
measure: Compare Need for Remobilization Between Mobilization Groups
timeFrame: Day 1
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Hien Duong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Hillard Lazarus, MD
role: PRINCIPAL_INVESTIGATOR
References: