Randomized, two arm, controlled study to compare the efficacy of oral ibandronate treatment versus intravenous zoledronate in patients with symptomatic Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003770-23-GB

Enrollment

424

Registered

2006-03-17

Start date

2006-04-11

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

Trade Name: Bondronat 50mg tablets Product Name: Bondronat 50mg tablets Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with multiple myeloma & confirmation of bone lesions • Age > 18 years • Patient’s written informed consent • WHO performance status 0-2 • Life expectancy of ? 6 months • Adequate renal function (defined by a creatinine clearance >60 ml/min) • No history of brain metastases Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Any circumstance liable to compromise follow-up and compliance • Pregnant or lactating period • Participation in a clinical trial with any investigational drug within 4 weeks preceding the first dose of the study drug • History of other concomitant cancer in evolution • Prior bisphosphonate treatment with the exception of bisphosphonate treatment for hypercalcemia and osteoporosis • Pre-scheduled radiotherapy that would fall within the study period

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of oral ibandronic acid 50 mg compared to intravenous zoledronate based on proportion of patients with Skeletal Related Event’s (SREs, defined as fractures, the need for radiotherapy to bone, the need for surgery to bone or spinal cord compression) in patients with symptomatic Multiple Myeloma.;Secondary Objective: • To asses the efficacy of oral ibandronic acid 50 mg compared to standard bisphosphonate therapy on: • Time to first SRE • Skeletal Morbidity Rate (SMR) • Time to multiple SREs by multivariate analyses • Bone pain and analgesic use • Overall survival • To assess the safety and tolerability profile of oral ibandronic acid versus intravenous zoledronate, with specific emphasis on renal Adverse Events (AEs) and acute phase AEs (within 3 days of dosing) ;Primary end point(s): • Proportion of patients with SREs	—

Measure

Time frame

Main Objective: To assess the efficacy of oral ibandronic acid 50 mg compared to intravenous zoledronate based on proportion of patients with Skeletal Related Event’s (SREs, defined as fractures, the need for radiotherapy to bone, the need for surgery to bone or spinal cord compression) in patients with symptomatic Multiple Myeloma.;Secondary Objective: • To asses the efficacy of oral ibandronic acid 50 mg compared to standard bisphosphonate therapy on: • Time to first SRE • Skeletal Morbidity Rate (SMR) • Time to multiple SREs by multivariate analyses • Bone pain and analgesic use • Overall survival • To assess the safety and tolerability profile of oral ibandronic acid versus intravenous zoledronate, with specific emphasis on renal Adverse Events (AEs) and acute phase AEs (within 3 days of dosing) ;Primary end point(s): • Proportion of patients with SREs

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Countries

Austria, Belgium, Estonia, Hungary, Latvia, Slovakia, Slovenia, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026