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Title Comparison of Plerixafor and G-CSF versus G-CSF Alone for Stem Cell Mobilization in Patients with Multiple Myeloma Previously Treated with Lenalidomide

IRB CASE 3A10

CC CC999

Hospital Main Campus

Stage N/A

Phase N/A

Disease Blood & Marrow Transplant (BMT), Multiple Myeloma

Drug AMD3100 (Plerixafor; Mozobil), G-CSF , Lenalidomide (Revlimid)

Description

Description

Study Objectives

  • As previously discussed, patients with multiple myeloma who have received prior lenalidomide therapy are known to have higher rates of failure of stem cell collection. We propose that the use of plerixafor with G-CSF can overcome this effect.

Primary Endpoint

  • The primary endpoint is ability to reach target collection of 5 x 106 CD34+ cells/kg with ≤ 2 days of leukapheresis using one of two mobilization regimens.

Secondary Endpoint

  • Percentage of patients achieving target goal CD34+ cell dose (as above) in ≤ 5 days of leukapheresis
  • Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other
  • Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups
Inclusion Criteria

Inclusion Criteria

  • Older than 18 years of age
  • 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 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 109/L
    • Absolute neutrophil count ≥ 1.2 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Creatinine clearance ≥ 30 mL/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

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