Vinorelbine and Gemcitabine in Myeloma
Condition: Multiple Myeloma; Amyloidosis
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Amyloidosis
Study type: Interventional
Phase: Phase 2

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 description: 
      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, at a dose of 30 Mio per day for patients ≤ 75kg, and of 48 Mio
      for patients >75kg.

      Planned accrual is 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% as an infusion over 30 minutes, on an
      ambulatory basis.

      G-CSF 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, at a dose of 30 Mio per day for patients ≤ 75kg, and of 48 Mio
      for patients >75kg.

      Planed accrual of 136 patients in 42 months.
    

Intervention name(s): Vinorelbine; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Mobilisation Chemotherapy; Mobilisation Chemotherapy
Other intervention name(s): Navelbine; Gemcitabine Sandoz
Intervention MeSH terms: Gemcitabine; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment