Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Granulocyte colony-stimulating factor plus plerixafor; Granulocyte colony-stimulating factor plus placebo
Intervention description: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.; Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Intervention MeSH terms: Plerixafor; Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and
      granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than
      G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma
      patients for autologous transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma in first or second complete or partial remission

          -  >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade
             were not considered prior chemotherapy for the purpose of this study)

          -  Recovered from all acute toxic effects of prior chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  White Blood Cell count (WBC) > 2.5*10^9/L

          -  Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L

          -  Platelet (PLT) > 100*10^9/L

          -  Serum creatinine <=2.2 mg/dL

          -  Cardiac and pulmonary status sufficient to undergo apheresis and transplantation

          -  Negative for HIV

        Exclusion Criteria):

          -  Failed previous stem cell collection

          -  Previous stem cell transplantation

          -  Brain metastases or myelomatous meningitis

          -  Radiation to ≥ 50% of the pelvis

          -  Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or
             other conduction abnormality

          -  Received bone-seeking radionuclides (e.g. holmium)

          -  A residual acute medical condition resulting from prior chemotherapy