Clinical Trial: Vinorelbine and Gemcitabine in Myeloma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Evaluation of Vinorelbine Versus Gemcitabine for Mobilization of Peripheral Stem Cells in Myeloma Patients Undergoing Autologous Stem Cell Transplantation.

Brief Summary: The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients

Detailed Summary:

Mobilization and engraftment of autologous peripheral blood progenitor cells (PBPC) in newly diagnosed multiple myeloma (MM) or amyloidosis patients followed by high dose chemotherapy with PBPC support.

Eligible are symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.

Chemotherapy with vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chlorid) as an infusion over 30 minutes, on an ambulatory basis.

G-CSF (granulocyte-colony stimulating factor) is given at 60 Mio s.c./d for patients ≤ 69kg in two daily doses of 30 Mio 12 hours apart, at 78 Mio s.c./d for patients from 70kg to 89kg with 48 Mio given in the morning and 30 Mio given in the evening, and at 96 Mio s.c./d for patients ≥ 90kg in two daily doses of 48 Mio.

Patients will be randomized in a 1:1 ratio between vinorelbine and gemcitabine mobilization. Patients will be stratified according to (A) response to induction treatment (refractory/stable disease/partial response versus very good partial response/complete response) and (B) peripheral neuropathy present versus absent before mobilization.

The high dose chemotherapy supported by autologous stem cell transplantation is not part of the study treatment. Standard high dose melphalan (200 mg/m2) will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +6 until day +11 after PBPC re-infusion,
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: CD34+ (cluster of differentiation 34) peripheral blood stem cells [ Time Frame: Day 8 ]

Number of patients with collection of > 6 million CD34+ peripheral blood stem cells/kg body weight at day 8 after vinorelbine versus gemcitabine chemotherapy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of peripheral neuropathy [ Time Frame: Between 15 and 30 days ]
    Number of patients with peripheral neuropathy following mobilization chemotherapy with vinorelbine versus gemcitabine. Clinical assessment will be done between 15 and 30 days after autologous transplant
  • Severity of peripheral neuropathy [ Time Frame: Between 15 and 30 days ]
    Grade of peripheral neuropathy following mobilization chemotherapy with vinorelbine versus gemcitabine. Clinical assessment will be done between 15 and 30 days after autologous transplant
  • Hematologic recovery [ Time Frame: Between 15 and 30 days ]
    Time (days) until hematologic recovery (Leucocytes > 3.0 G/L and Thrombocytes >100 G/L) following autologous transplantation comparing patients mobilized with vinorelbine versus gemcitabine.
  • Minimal residual disease in the peripheral blood [ Time Frame: Day 8 ]
    Minimal residual disease in the peripheral blood at the day of stem cell collection (day 8) using flow cytometry multiparameter assessment comparing patients mobilized with vinorelbine versus gemcitabine.
  • Need to use the stem cell releasing compound Plerixafor [ Time Frame: Day 8 ]
    Number of patients who needs to use the stem cell releasing compound Plerixafor at day 9 in patients with insufficient peripheral stem cell mobilization (at day 8) comparing patients mobilized with vinorelbine versus gemcitabine.
  • Response Rate [ Time Frame: Between 15 and 30 days ]
    Response (myeloma parameter) to the mobilization chemotherapy comparing patients mobilized with vinorelbine versus gemcitabine.


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: June 1, 2016
Date Started: March 2014
Date Completion: December 2017
Last Updated: February 21, 2017
Last Verified: February 2017