Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416208
• Other study ID #: CR006127
• Secondary ID: 26866138MMY3013
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2006
• Last updated: March 4, 2015
• Start date: October 2006
• Est. completion date: May 2013

Study information

• Verified date: March 2015
• Source: Janssen-Cilag G.m.b.H
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 61 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib
1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag G.m.b.H

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in event-free survival time will be compared between both arms		Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up	No
Secondary	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		Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up	Yes

External Links

•   Consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75