Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
2 other identifiers
interventional
154
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Oct 2006
Typical duration for phase_3 multiple-myeloma
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 22, 2006
CompletedFirst Posted
Study publicly available on registry
December 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMarch 5, 2015
March 1, 2015
6.6 years
December 22, 2006
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (2)
Bortezomib
EXPERIMENTALBortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
Observation
NO INTERVENTIONObservational arm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Bamberg, Germany
Unknown Facility
Berg, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Bremen, Germany
Unknown Facility
Dortmund, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Duisburg, Germany
Unknown Facility
Erlangen, Germany
Unknown Facility
Eschweiler, Germany
Unknown Facility
Frankfurt am Main, Germany
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Goch, Germany
Unknown Facility
Göttingen, Germany
Unknown Facility
Greifswald, Germany
Unknown Facility
Halle, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hamm, Germany
Unknown Facility
Jena, Germany
Unknown Facility
Karlsruhe, Germany
Unknown Facility
Kempten, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Kÿln N/A, Germany
Unknown Facility
Lübeck, Germany
Unknown Facility
Magdeburg, Germany
Unknown Facility
Mutlangen, Germany
Unknown Facility
München, Germany
Unknown Facility
Münster, Germany
Unknown Facility
Nuremberg, Germany
Unknown Facility
Oldenburg, Germany
Unknown Facility
Regensburg, Germany
Unknown Facility
Rostock, Germany
Unknown Facility
Stuttgart, Germany
Unknown Facility
Trier, Germany
Unknown Facility
Ulm, Germany
Unknown Facility
Villingen-Schwenningen, Germany
Unknown Facility
Wiesbaden, Germany
Unknown Facility
Würzburg, Germany
Related Publications (2)
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.
PMID: 31231828DERIVEDEinsele 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.
PMID: 28293022DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag G.m.b.H. Clinical Trial
Janssen-Cilag G.m.b.H
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2006
First Posted
December 27, 2006
Study Start
October 1, 2006
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
March 5, 2015
Record last verified: 2015-03