Trial Information

Summary: COMPARE Study: A Study to Compare the Renal Safety of Bondronat (Ibandronate) and Zoledronate in Patients With Multiple Myeloma

Status: Recruiting

Protocol Number: ML18508

Sponsor: Hoffmann-La Roche AG

Company Division: Pharmaceutical

Official Scientific Title: COMPARE: A randomized, open-label study to compare the nephrotoxicity of Bondronat and zoledronate in patients with multiple myeloma

Brief Summary: This study will compare the effect of intravenous Bondronat and zoledronate on renal toxicity, in terms of serum creatinine levels, and efficacy, in terms of skeletal events, in patients with multiple myeloma. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 448.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Multiple Myeloma

Intervention Type: Drug

Intervention Name: ibandronate[Bondronat]

Primary Outcome: 1. Renal safety: number of patients with a pre-specified increase from baseline in serum creatinine at week 96

Key Secondary Outcomes: 1. Efficacy: time until first skeletal event, number of skeletal events, proportion of patients with >=1 skeletal event Safety: frequency of dose reduction under zoledronate, creatinine clearance, incidence of osteonecrosis of the jaw

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2006

Trial Registration Date: 03/10/2006

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 4:59:21 PM