COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

COMPARE: Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Patients With Multiple Myeloma

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

• Multiple Myeloma
• Neoplasms, Plasma Cell

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