Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Clinical trial, Bortezomib, PS341, Proteasome inhibitor, Consolidation therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bortezomib
Observation
Arm Description
Bortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
Observational arm
Outcomes
Primary Outcome Measures
The difference in event-free survival time will be compared between both arms
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00416208
Brief Title
Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
Official Title
Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag G.m.b.H
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Clinical trial, Bortezomib, PS341, Proteasome inhibitor, Consolidation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib
Arm Type
Experimental
Arm Description
Bortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Observational arm
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
61 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag G.m.b.H. Clinical Trial
Organizational Affiliation
Janssen-Cilag G.m.b.H
Official's Role
Study Director
Facility Information:
City
Bamberg
Country
Germany
City
Berg
Country
Germany
City
Berlin
Country
Germany
City
Bremen
Country
Germany
City
Dortmund
Country
Germany
City
Dresden
Country
Germany
City
Duisburg
Country
Germany
City
Erlangen
Country
Germany
City
Eschweiler
Country
Germany
City
Frankfurt / Main
Country
Germany
City
Freiburg
Country
Germany
City
Goch
Country
Germany
City
Greifswald
Country
Germany
City
Göttingen
Country
Germany
City
Halle
Country
Germany
City
Hamburg
Country
Germany
City
Hamm
Country
Germany
City
Jena
Country
Germany
City
Karlsruhe
Country
Germany
City
Kempten
Country
Germany
City
Kiel
Country
Germany
City
Kÿln N/A
Country
Germany
City
Lübeck
Country
Germany
City
Magdeburg
Country
Germany
City
Mutlangen
Country
Germany
City
München
Country
Germany
City
Münster
Country
Germany
City
Nürnberg
Country
Germany
City
Oldenburg
Country
Germany
City
Regensburg
Country
Germany
City
Rostock
Country
Germany
City
Stuttgart
Country
Germany
City
Trier
Country
Germany
City
Ulm
Country
Germany
City
Villingen-Schwenningen
Country
Germany
City
Wiesbaden
Country
Germany
City
Würzburg
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
31231828
Citation
Straka C, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Fischer T, Liebisch P, Engelhardt M, Einsele H. Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. Eur J Haematol. 2019 Sep;103(3):255-267. doi: 10.1111/ejh.13281. Epub 2019 Jul 19.
Results Reference
derived
PubMed Identifier
28293022
Citation
Einsele H, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Engelhardt M, Fischer T, Liebisch P, Straka C. Response-adapted consolidation with bortezomib after ASCT improves progression-free survival in newly diagnosed multiple myeloma. Leukemia. 2017 Jun;31(6):1463-1466. doi: 10.1038/leu.2017.83. Epub 2017 Mar 15. No abstract available.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=243&filename=CR006127_CSR.pdf
Description
Consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75
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Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
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