Clinical trial NCT02739594: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma
Official title: COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2016-04-15
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)
* Indication for biphosphonate therapy

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

Primary outcomes:
measure: Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44
timeFrame: Baseline, Week 44
measure: Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92
timeFrame: Baseline, Week 92
Secondary outcomes:
measure: Percentage of Participants With Skeletal-Related Events (SREs)
timeFrame: From Baseline to end of study (up to Week 96)
measure: Time to First SRE
timeFrame: From Baseline to end of study (up to Week 96)
measure: Number of SREs for Each Participant
timeFrame: From Baseline to end of study (up to Week 96)
measure: Percentage of Participants With Osteonecrosis of Jaw
timeFrame: From Baseline to end of study (up to Week 96)
measure: Number of Events of Osteonecrosis of Jaw for Each Participant
timeFrame: From Baseline to end of study (up to Week 96)
measure: Percentage of Participants With Zoledronate Dose Reduction
timeFrame: From Baseline to end of study (up to Week 96)
measure: Number of Zoledronate Dose Reductions for Each Participant
timeFrame: From Baseline to end of study (up to Week 96)
measure: Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)
timeFrame: Baseline and Weeks 44, 92
measure: Percent Change From Baseline in Alpha (A) 1-Microglobulin
timeFrame: Baseline and Weeks 44, 92
measure: Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)
timeFrame: Baseline and Weeks 44, 92
measure: Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
timeFrame: Baseline and Weeks 44, 92
measure: Percent Change From Baseline in CrCl
timeFrame: Baseline and Weeks 44, 92
Other outcomes:
Locations:
city: Ansbach
country: Germany
city: Aschaffenburg
country: Germany
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Duisburg
country: Germany
city: Duisburg
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Esslingen
country: Germany
city: Frankfurt Am Main
country: Germany
city: Frankfurt Am Main
country: Germany
city: Greifswald
country: Germany
city: Göttingen
country: Germany
city: Güstrow
country: Germany
city: Gütersloh
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamm
country: Germany
city: Hannover
country: Germany
city: Hannover
country: Germany
city: Herne
country: Germany
city: Hof
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Kassel
country: Germany
city: Kassel
country: Germany
city: Koblenz
country: Germany
city: Krefeld
country: Germany
city: Köln
country: Germany
city: Köln
country: Germany
city: Leer
country: Germany
city: Leipzig
country: Germany
city: Ludwigshafen
country: Germany
city: Lübeck
country: Germany
city: Magedburg
country: Germany
city: Minden
country: Germany
city: Moers
country: Germany
city: Muenster
country: Germany
city: Mülheim
country: Germany
city: München
country: Germany
city: Neumünster
country: Germany
city: Offenbach
country: Germany
city: Offenburg
country: Germany
city: Oldenburg
country: Germany
city: Oldenburg
country: Germany
city: Stuttgart
country: Germany
city: Stuttgart
country: Germany
city: Tübingen
country: Germany
city: Weiden
country: Germany
city: Wiesbaden
country: Germany
city: Würzburg
country: Germany
city: Zwickau
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: