Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00002426

Trial Description

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Title

Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00002426
  •   2012/11/19
  •   2006/12/22
  •   no
  •   Approved
  •   293/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT00416208  (Clinicaltrials.gov)
  •   CR006127  (Janssen-Cilag G.m.b.H)
  •   26866138MMY3013 
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Health Condition or Problem studied

  •   Multiple Myeloma
  •   C90.0 -  Multiple myeloma
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Interventions/Observational Groups

  •   Drug: Bortezomib
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- The difference in event-free survival time will be compared between both arms; time frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up

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Secondary Outcome

- Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly; time frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2006/10/31
  •   154
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   61   Years
  •   75   Years
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Additional Inclusion Criteria

- Patients who have had pretreatment with single or tandem high dose melphalan therapy
and autologous stem cell transplantation as first line therapy

- at least stable disease after stem cell transplantation

- adequate hematological, hepatic and renal lab parameters

- karnofsky status of 70 or more

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Exclusion Criteria

- non-secretory multiple myeloma

- previous treatment with bortezomib

- allogenic stem cell transplantation

- other co-existing malignancy beside basaliome

- peripheral neuropathy

- epilepsia

- other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious
etc.)

- history of allergic reactions to bortezomib or mannitol

- expected life expectancy of less than 3 months

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Addresses

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    • Janssen-Cilag G.m.b.H
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    • Janssen-Cilag G.m.b.HJanssen-Cilag G.m.b.H Clinical Trial
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    • Janssen-Cilag G.m.b.HJanssen-Cilag G.m.b.H Clinical Trial
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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   9
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.