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Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

NCT02739594 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2016-07-22

Study results available
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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.

Conditions

Interventions

DRUG

Ibandronate

Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.

DRUG

Zoledronate

Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02739594 on ClinicalTrials.gov