Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

Last updated: June 9, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Terminated

Phase

3

Condition

Multiple Myeloma

Cancer/tumors

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT02739594
ML18508
2005-003264-38
  • Ages > 18
  • All Genders

Study Summary

This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/min) or lower.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)

  • Indication for biphosphonate therapy

Exclusion

Exclusion Criteria:

  • Previous therapy with ibandronate or zoledronate within the past 12 months

  • 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

Study Design

Total Participants: 89
Study Start date:
February 01, 2006
Estimated Completion Date:
April 30, 2009

Connect with a study center

  • Ansbach, 91522
    Germany

    Site Not Available

  • Aschaffenburg, 63739
    Germany

    Site Not Available

  • Augsburg, 86150
    Germany

    Site Not Available

  • Berlin, 12627
    Germany

    Site Not Available

  • Bremen, 28239
    Germany

    Site Not Available

  • Duisburg, 47166
    Germany

    Site Not Available

  • Erlangen, 91054
    Germany

    Site Not Available

  • Essen, 45136
    Germany

    Site Not Available

  • Esslingen, 73730
    Germany

    Site Not Available

  • Frankfurt Am Main, 60389
    Germany

    Site Not Available

  • Greifswald, 17475
    Germany

    Site Not Available

  • Göttingen, 37075
    Germany

    Site Not Available

  • Güstrow, 18273
    Germany

    Site Not Available

  • Gütersloh, 33332
    Germany

    Site Not Available

  • Halle, 06110
    Germany

    Site Not Available

  • Hamburg, 22081
    Germany

    Site Not Available

  • Hamm, 59063
    Germany

    Site Not Available

  • Hannover, 30171
    Germany

    Site Not Available

  • Herne, 44625
    Germany

    Site Not Available

  • Hof, 95028
    Germany

    Site Not Available

  • Jena, 07743
    Germany

    Site Not Available

  • Karlsruhe, 76137
    Germany

    Site Not Available

  • Kassel, 34125
    Germany

    Site Not Available

  • Koblenz, 56068
    Germany

    Site Not Available

  • Krefeld, 47798
    Germany

    Site Not Available

  • Köln, 50924
    Germany

    Site Not Available

  • Leer, 26789
    Germany

    Site Not Available

  • Leipzig, 04289
    Germany

    Site Not Available

  • Ludwigshafen, 67063
    Germany

    Site Not Available

  • Lübeck, 23562
    Germany

    Site Not Available

  • Magedburg, 39104
    Germany

    Site Not Available

  • Minden, 32427
    Germany

    Site Not Available

  • Moers, 47441
    Germany

    Site Not Available

  • Muenster, 48149
    Germany

    Site Not Available

  • Mülheim, 45468
    Germany

    Site Not Available

  • München, 80336
    Germany

    Site Not Available

  • empty

    Neumunster, 24534
    Germany

    Site Not Available

  • Neumünster, 24534
    Germany

    Site Not Available

  • Offenbach, 63069
    Germany

    Site Not Available

  • Offenburg, 77652
    Germany

    Site Not Available

  • Oldenburg, 26133
    Germany

    Site Not Available

  • Stuttgart, 70174
    Germany

    Site Not Available

  • Tübingen, 72076
    Germany

    Site Not Available

  • Weiden, 92637
    Germany

    Site Not Available

  • Wiesbaden, 65191
    Germany

    Site Not Available

  • Würzburg, 97080
    Germany

    Site Not Available

  • Zwickau, 08058
    Germany

    Site Not Available

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