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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


Phase 3
18 Years
60 Years
Not Enrolling
Both
Multiple Myeloma

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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. √ćnterferon 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.


Inclusion Criteria:



- Patients (age < = 60 years) with multiple myeloma with prior therapy consisting of
remission induction therapy and high dose chemotherapy followed by stem cell
transplantation

- women must be postmenopausal or using safe contraception methods

- creatinin clearance has to be higher than 30 ml/min and whole blood count has to be
within acceptable ranges

Exclusion Criteria:

- No asecretory multiple myeloma

- history of allergic reactions to bortezomib or mannitol

- expected life expectancy of less than 3 months

- no other malignant disease beside basalioma either existing or history of

- no history of severe cardio-pulmonary disease

- seizures.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The difference in event-free survival time will be compared between both arms

Principal Investigator

Janssen-Cilag G.m.b.H. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag G.m.b.H

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CR006124

NCT ID:

NCT00416273

Start Date:

December 2006

Completion Date:

May 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • clinical trial
  • bortezomib
  • PS341
  • proteasome inhibitor
  • consolidation therapy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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