Clinical trial NCT00416273: A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma
Official title: Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Bortezomib
PS341
Proteasome inhibitor
Consolidation therapy
Lead sponsor: Janssen-Cilag G.m.b.H
Sponsor class: INDUSTRY
First posted: 2006-12-27
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.

Detailed description: This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) randomized (the study medication is assigned by chance), multi-center study. Approximately 385 patients will be enrolled in this study. Patients will be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration from screening up to the study end is up to 27 weeks. Then the patients will be observed until the last included patient has completed a 30 month post observational phase. The patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35 days. Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests.

Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation
* Women must be postmenopausal or using safe contraception methods
* Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges

Exclusion Criteria:

* No asecretory multiple myeloma
* History of allergic reactions to bortezomib or mannitol
* Expected life expectancy of less than 3 months
* No other malignant disease beside basalioma either existing or history of
* No history of severe cardio-pulmonary disease
* Seizures

Primary outcomes:
measure: Number of patients with event-free survival (PFS)
timeFrame: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled
Secondary outcomes:
measure: Number of patients with event free survival (EFS)
timeFrame: From date of first chemotherapeutic myeloma-specific treatment measure until the occurrence of the beginning of a new chemotherapeutic therapy,or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled
measure: Response rates
timeFrame: Up to Week 25
measure: Overall survival
timeFrame: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled
measure: Time to progression
timeFrame: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled
measure: Duration of response
timeFrame: Up to Week 25
measure: Number of patients with toxicities over the treatment period
timeFrame: Up to Week 24
measure: Change From Baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)
timeFrame: Baseline (Day 1), Enpoint (30-60 months)
measure: Number of the patients with skeletal related event (SRE)
timeFrame: Up to 30-60 months
measure: Time interval from the day of the transplantation up to the occurrence of the first SRE
timeFrame: Up to 30-60 months
measure: Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to end point (30-60 months)
timeFrame: Baseline (Day 1) and end point (30-60 months)
Other outcomes:
Locations:
city: Augsburg
country: Germany
city: Bamberg
country: Germany
city: Berg
country: Germany
city: Berlin
country: Germany
city: Bremen
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: Hannover
country: Germany
city: Homburg
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Kempten
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Magdeburg
country: Germany
city: Mainz
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: Ulm
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Wiesbaden
country: Germany
city: Würzburg
country: Germany
Study officials:
affiliation: Janssen-Cilag G.m.b.H
name: Janssen-Cilag G.m.b.H, Germany Clinical Trial
role: STUDY_DIRECTOR
References:
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.
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.