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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02739594
Other study ID # ML18508
Secondary ID 2005-003264-38
Status Terminated
Phase Phase 3
First received April 12, 2016
Last updated April 12, 2016
Start date February 2006
Est. completion date April 2009

Study information

Verified date April 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This multicenter, open-label trial randomized 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.


Recruitment information / eligibility

Status Terminated
Enrollment 89
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 (mcmol/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 less than or equal to (</=) 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ibandronate
Ibandronate was administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
Zoledronate
Zoledronate was administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hoffmann-La Roche Roche Pharma AG, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Deterioration in Renal Function According to Reduction in CrCl from Baseline to Week 44 Baseline to Week 44 Yes
Primary Percentage of Participants with Deterioration in Renal Function According to Reduction in CrCl from Baseline to Week 92 Baseline to Week 92 Yes
Secondary Time to First Skeletal-Related Adverse Event (SRE) According to Medical Dictionary for Regulatory Activities (MedDRA) Classification Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) Yes
Secondary Number of SREs According to MedDRA Classification Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) Yes
Secondary Number of Participants with SREs According to MedDRA Classification Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) Yes
Secondary Number of Participants with Osteonecrosis of Jaw Screening; pre-dose (0 hours) and on Days 2, 3, 4 of every other treatment (every 8 weeks); at Week 68; and end of study (up to 92 weeks overall) Yes
Secondary Percentage of Participants with Any Zoledronate Dose Reduction Screening, then every 4 weeks during treatment (up to 92 weeks overall) No
Secondary Change from Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG) Baseline to Weeks 44, 92 Yes
Secondary Change from Baseline in Alpha-1-Microglobulin Baseline to Weeks 44, 92 Yes
Secondary Change from Baseline in Gamma-Glutamyltransferase (GGT) Baseline to Weeks 44, 92 Yes
Secondary Number of Participants with Serum Creatinine Increase >0.5 Milligrams per Deciliter (mg/dL) from Baseline Baseline to Weeks 44, 92 Yes
Secondary Number of Participants with Serum Creatinine Increase >1.0 mg/dL from Baseline Baseline to Weeks 44, 92 Yes
Secondary Change from Baseline in CrCl Baseline to Weeks 44, 92 Yes
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