Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma
NCT ID: NCT02739594
Last Updated: 2016-07-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
89 participants
INTERVENTIONAL
2006-02-28
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ibandronate
Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks.
Ibandronate
Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
Zoledronate
Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.
Zoledronate
Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
Interventions
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Ibandronate
Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
Zoledronate
Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication for biphosphonate therapy
Exclusion Criteria
* Renal insufficiency with serum creatinine \>3.0 mg/dL or \>265 micromoles per liter (µmol/L) or CrCl \<30 mL/min
* Hypersensitivity to ibandronate, zoledronate, or other biphosphonates
* Presence of secondary malignomas, apart from basaliomas and cervical carcinoma in situ
* Severe accompanying illness with organ impairment
* Osteonecrosis of the jaw at the start of the study
* Life expectancy ≤12 months
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Ansbach, , Germany
Aschaffenburg, , Germany
Augsburg, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Bremen, , Germany
Cologne, , Germany
Cologne, , Germany
Duisburg, , Germany
Duisburg, , Germany
Erlangen, , Germany
Essen, , Germany
Esslingen am Neckar, , Germany
Frankfurt am Main, , Germany
Frankfurt am Main, , Germany
Göttingen, , Germany
Greifswald, , Germany
Güstrow, , Germany
Gütersloh, , Germany
Halle, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamm, , Germany
Hanover, , Germany
Hanover, , Germany
Herne, , Germany
Hof, , Germany
Jena, , Germany
Karlsruhe, , Germany
Kassel, , Germany
Kassel, , Germany
Koblenz, , Germany
Krefeld, , Germany
Leer, , Germany
Leipzig, , Germany
Ludwigshafen, , Germany
Lübeck, , Germany
Magedburg, , Germany
Minden, , Germany
Moers, , Germany
Mülheim, , Germany
München, , Germany
Münster, , Germany
Neumünster, , Germany
Offenbach, , Germany
Offenburg, , Germany
Oldenburg, , Germany
Oldenburg, , Germany
Stuttgart, , Germany
Stuttgart, , Germany
Tübingen, , Germany
Weiden, , Germany
Wiesbaden, , Germany
Würzburg, , Germany
Zwickau, , Germany
Countries
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Other Identifiers
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2005-003264-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML18508
Identifier Type: -
Identifier Source: org_study_id
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