Study Stopped
Slow recruitment
Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma
COMPARE
COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma
2 other identifiers
interventional
89
1 country
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 multiple-myeloma
Started Feb 2006
Shorter than P25 for phase_3 multiple-myeloma
56 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
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedResults Posted
Study results publicly available
July 22, 2016
CompletedJuly 22, 2016
June 1, 2016
3.2 years
April 12, 2016
June 9, 2016
June 9, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44
CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.
Baseline, Week 44
Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92
CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported.
Baseline, Week 92
Secondary Outcomes (12)
Percentage of Participants With Skeletal-Related Events (SREs)
From Baseline to end of study (up to Week 96)
Time to First SRE
From Baseline to end of study (up to Week 96)
Number of SREs for Each Participant
From Baseline to end of study (up to Week 96)
Percentage of Participants With Osteonecrosis of Jaw
From Baseline to end of study (up to Week 96)
Number of Events of Osteonecrosis of Jaw for Each Participant
From Baseline to end of study (up to Week 96)
- +7 more secondary outcomes
Study Arms (2)
Ibandronate
EXPERIMENTALParticipants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks.
Zoledronate
ACTIVE COMPARATORParticipants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.
Interventions
Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
Eligibility Criteria
You may qualify if:
- Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)
- Indication for biphosphonate therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Roche Pharma AGcollaborator
Study Sites (56)
Unknown Facility
Ansbach, 91522, Germany
Unknown Facility
Aschaffenburg, 63739, Germany
Unknown Facility
Augsburg, 86150, Germany
Unknown Facility
Berlin, 10437, Germany
Unknown Facility
Berlin, 10707, Germany
Unknown Facility
Berlin, 12627, Germany
Unknown Facility
Bremen, 28239, Germany
Unknown Facility
Cologne, 50677, Germany
Unknown Facility
Cologne, 50924, Germany
Unknown Facility
Duisburg, 47051, Germany
Unknown Facility
Duisburg, 47166, Germany
Unknown Facility
Erlangen, 91054, Germany
Unknown Facility
Essen, 45136, Germany
Unknown Facility
Esslingen am Neckar, 73730, Germany
Unknown Facility
Frankfurt am Main, 60389, Germany
Unknown Facility
Frankfurt am Main, 65929, Germany
Unknown Facility
Göttingen, 37075, Germany
Unknown Facility
Greifswald, 17475, Germany
Unknown Facility
Güstrow, 18273, Germany
Unknown Facility
Gütersloh, 33332, Germany
Unknown Facility
Halle, 06110, Germany
Unknown Facility
Hamburg, 22081, Germany
Unknown Facility
Hamburg, 22457, Germany
Unknown Facility
Hamm, 59063, Germany
Unknown Facility
Hanover, 30171, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Herne, 44625, Germany
Unknown Facility
Hof, 95028, Germany
Unknown Facility
Jena, 07743, Germany
Unknown Facility
Karlsruhe, 76137, Germany
Unknown Facility
Kassel, 34117, Germany
Unknown Facility
Kassel, 34125, Germany
Unknown Facility
Koblenz, 56068, Germany
Unknown Facility
Krefeld, 47798, Germany
Unknown Facility
Leer, 26789, Germany
Unknown Facility
Leipzig, 04289, Germany
Unknown Facility
Ludwigshafen, 67063, Germany
Unknown Facility
Lübeck, 23562, Germany
Unknown Facility
Magedburg, 39104, Germany
Unknown Facility
Minden, 32427, Germany
Unknown Facility
Moers, 47441, Germany
Unknown Facility
Mülheim, 45468, Germany
Unknown Facility
München, 80336, Germany
Unknown Facility
Münster, 48149, Germany
Unknown Facility
Neumünster, 24534, Germany
Unknown Facility
Offenbach, 63069, Germany
Unknown Facility
Offenburg, 77652, Germany
Unknown Facility
Oldenburg, 26121, Germany
Unknown Facility
Oldenburg, 26133, Germany
Unknown Facility
Stuttgart, 70174, Germany
Unknown Facility
Stuttgart, 70199, Germany
Unknown Facility
Tübingen, 72076, Germany
Unknown Facility
Weiden, 92637, Germany
Unknown Facility
Wiesbaden, 65191, Germany
Unknown Facility
Würzburg, 97080, Germany
Unknown Facility
Zwickau, 08058, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Study was terminated as a result of slow recruitment. At the time of the decision to halt recruitment, the treatment duration was shortened to 40 weeks (instead of 92 weeks) for those participants who had not yet reached Week 48.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
April 12, 2016
First Posted
April 15, 2016
Study Start
February 1, 2006
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
July 22, 2016
Results First Posted
July 22, 2016
Record last verified: 2016-06