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

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01301963
First received: February 22, 2011
Last updated: October 21, 2013
Last verified: October 2013

February 22, 2011
October 21, 2013
July 2011
June 2013   (final data collection date for primary outcome measure)
Ability to reach target collection of 5 x 10^6 CD34+ cells/kg [ Time Frame: In =< 2 days of leukaphereses ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01301963 on ClinicalTrials.gov Archive Site
  • Percentage of patients achieving target goal CD34+ cells dose [ Time Frame: In =< 5 days of leukaphereses ] [ Designated as safety issue: No ]
  • Compare hematopoietic stem cells/kg collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other [ Time Frame: By day 1 ] [ Designated as safety issue: No ]
    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 days of apheresis between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Using the Wilcoxon Rand Sum Test
  • Compare need for hospitalization during mobilization between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Compare need for remobilization between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Using the Chi-square test or Fisher's exact test, as appropriate.
  • Percentage of patients achieving target goal CD34+ cells dose [ Time Frame: In =< 5 days of leukaphereses ] [ Designated as safety issue: No ]
  • Compare cells/kg collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other [ Time Frame: By day 1 ] [ Designated as safety issue: No ]
    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 days of apheresis between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Using the Wilcoxon Rand Sum Test
  • Compare need for hospitalization during mobilization between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Compare need for remobilization between mobilization groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Using the Chi-square test or Fisher's exact test, as appropriate.
Not Provided
Not Provided
 
Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory Multiple Myeloma
  • Drug: plerixafor
    Given SC
    Other Names:
    • AMD 3100
    • Mozobil
  • Biological: filgrastim
    Given SC
    Other Names:
    • G-CSF
    • Neupogen
  • Active Comparator: Arm I
    Patients receive G-CSF SC QD on days 1-4.
    Intervention: Biological: filgrastim
  • Experimental: Arm II
    Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
    Interventions:
    • Drug: plerixafor
    • Biological: filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301963
CASE3A10, NCI-2011-00186
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Hien Duong, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Principal Investigator: Hillard Lazarus, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP