PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT01220375
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine, G-CSF, & Plerixafor — DRUG
    Patients 1-10 receive 35 mg/m2 vinorelbine i.v. on day 1, G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
  • Vinorelbine and Plerixafor — DRUG
    Patients 11-20 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No G-CSF will be administered. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
  • G-CSF and Plerixafor — DRUG
    Patients 21-30 receive G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No chemotherapy with vinorelbine will be gine on day 1. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
  • Vinorelbine & Plerixafor on day when CD34 count is at least 15'000 CD34+ cells/ml of peripheral blood — DRUG
    Patients 31-40 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application at 08:00 AM, on the first day on which the CD34 count has risen to at least 15'000 CD34+ cells/ml of peripheral blood. Stem cell collection is initiated 4 hours later (at 12:00 PM) on this day. No G-CSF will be administered.

Study Details

High-dose chemotherapy with autologous stem cell support is the current standard procedure in the first-line treatment in younger patients with myeloma fit for intensive treatment. Current practice in Switzerland for stem cell mobilization is the combination of chemotherapy and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with melphalan and autologous stem cell transplant. In this trial the intravenous application of Plerixafor is being investigated in respect of the capability of the mobilization of stem cells from the bone marrow into the peripheral blood. In contrast to the twice daily application of G-CSF (eg. Neupogen) for several days, Plerixafor has to be injected just one-time.

Key Dates

Start date
Apr 30, 2010
Status verified
Apr 2014
Primary completion
Jan 31, 2012
Completion
Oct 31, 2013

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Plerixafor is a bicyclam with hematopoietic stem cell-mobilizing activity. Plerixafor blocks the binding of stromal cell-derived factor (SDF-1alpha) to the cellular receptor CXCR4, resulting in hematopoietic stem cell release from bone marrow and HSC movement into the peripheral circulation.

Primary Outcome Measure

Number of patients from whom ≥ 6 million CD34+ peripheral blood stem cells/kg are harvested in a maximum of 2 days [ Time Frame: day 8 (and 9, if necessary) / 2 days after G-CSF ]

Related Studies