Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy
      with bortezomib in patients with multiple myeloma aged 61 to 75.
    

Detailed description: 
      No data supporting the use of bortezomib as a consolidation therapy in multiple myeloma
      patients are available. Ínterferon tested as consolidation / maintenance therapy has not
      uniformly proven to prolong survival. In this study the hypothesis is being tested that
      bortezomib is able to increase duration of response and thus improving survival. This
      hypothesis is based on the results of the approval study where bortezomib has been tested to
      improve these endpoints.This is a multicenter, open-label, randomized (patients are assigned
      to different treatment group by chance) phase III study to evaluate the efficacy and safety
      of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75.
      Three months after receiving high dose melphalan with autologous stem cell transplantation
      patients will be randomized to receive either consolidation therapy with bortezomib or to be
      monitored without consolidation therapy. Subjects in the consolidation group will be treated
      up to 4 cycles (6 weeks each). The main study phase has a duration of 24 weeks. The trial
      ends after the last enrolled patient has completed a follow-up period of 30 months. The
      primary objective is to determine the event free survival in treatment and observation group.
      The secondary objectives are to assess the response rate, overall survival, duration of
      response, time to progression, short- and long-term toxicities, quality of life and
      cytogenetic analyses with regard to treatment response, event free survival and overall
      survival. Primary efficacy analysis: Event free survival is defined as the time from the
      first disease-related therapeutic procedure until death, progress or relapse. Secondary
      efficacy analyses: response rate of the treatment group (measured by the relative change of
      M-protein levels in serum or urine); overall survival is defined as the time from the first
      therapeutic procedure until death; time to progression is defined as the duration from the
      date of enrolment until the date of first documented evidence of progressive disease or
      relapse; duration of response is defined as the duration in months from the date of first
      evidence of confirmed response to the date of first documented evidence of progressive
      disease or relapse; quality of life is assessed by the questionnaires EORTC QLQ-C30 (Quality
      of life questionnaire) and EORTC EQ-5D (Euro Quality of life). Consolidation therapy lasts 4
      cycles. Subjects will be treated with bortezomib 1.6 mg/m2 body surface intravenously once
      weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 35).
      At least 72 hours should relapse between consecutive doses of bortezomib. Therapy should be
      withheld at the onset of any Grade 3 nonhematological or Grade 4 hematological toxicities
      excluding neuropathy.
    

Intervention name(s): Bortezomib
Intervention type(s): Drug
Intervention description(s): 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
Intervention MeSH terms: Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Clinical trial; Bortezomib; PS341; Proteasome inhibitor; Consolidation therapy