Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT00416208
First received: December 22, 2006
Last updated: April 2, 2014
Last verified: April 2014

December 22, 2006
April 2, 2014
October 2006
May 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The difference in event-free survival time will be compared between both arms
Complete list of historical versions of study NCT00416208 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assesments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly
Not Provided
Not Provided
 
Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Bortezomib
1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
  • Experimental: Bortezomib
    Bortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
    Intervention: Drug: Bortezomib
  • No Intervention: Observation
    Observational arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
May 2013
May 2013   (final data collection date for primary outcome measure)

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 etc.)
  • history of allergic reactions to bortezomib or mannitol
  • expected life expectancy of less than 3 months
Both
61 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00416208
CR006127, 26866138MMY3013
No
Janssen-Cilag G.m.b.H
Janssen-Cilag G.m.b.H
Not Provided
Study Director: Janssen-Cilag G.m.b.H. Clinical Trial Janssen-Cilag G.m.b.H
Janssen-Cilag G.m.b.H
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP