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

Phase 3
61 Years
75 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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

No data supporting the use of bortezomib as a consolidation therapy in multiple myeloma
patients are available. ├Źnterferon 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.

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

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

- history of allergic reactions to bortezomib or mannitol

- expected life expectancy of less than 3 months

Type of Study:


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

Outcome Time Frame:

Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up

Safety Issue:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag G.m.b.H


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2006

Completion Date:

May 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Clinical trial
  • Bortezomib
  • PS341
  • Proteasome inhibitor
  • Consolidation therapy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell