Trial Information

Ph. III Trial to Evaluate Safety and Efficacy of Bortezomib as Consolidation Treatment vs Observation in Patients With Multiple Myeloma Aged <= 60 After Receiving Induction Therapy Prior to Stem Cell Mobilisation and Highdose Melphalan Followed by Autologous or Allogenic Stem Cell Transplantation

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. 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.