Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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:
- adult patients, >=18 years of age;
- confirmed multiple myeloma (stage II and III) where treatment with bisphosphonates is indicated,
Exclusion criteria:
- previous treatment with Bondronat or zoledronate within the last 12 months;
- renal insufficiency;
- presence of secondary malignant neoplasms, except for basalioma or cervical cancer in situ;
- hypersensitivity to bondronat, zolendronate or other bisphosphonates.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2006
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Aschaffenburg
- Augsburg
- Berlin
- Bremen
- Duisburg
- Essen
- Esslingen
- Frankfurt Am Main
- Göttingen
- Güstrow
- Gütersloh
- Hamburg
- Hamm
- Hannover
- Herne
- Jena
- Karlsruhe
- Kassel
- Koblenz
- Köln
- Leer
- Leipzig
- Ludwigshafen
- Magdeburg
- Minden
- München
- Münster
- Neumünster
- Offenbach
- Offenburg
- Oldenburg
- Stuttgart
- Weiden
- Wiesbaden
- Würzburg
- Zwickau
