A Multiple Myeloma Trial in Patients With Bone Metastases

Novartis

Status and phase: Completed; Phase 4

Conditions: Multiple Myeloma

Treatments: Drug: zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00104104

CZOL446EUS97

US97

Details and patient eligibility

About

The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older
• Confirmed diagnosis of Multiple Myeloma
• Stable renal function defined as two serum creatinine determinations of < 3 mg/dL
• Calculated creatinine clearance of greater than or equal to 30 mL/min
• ECOG Performance Status of 0 or 1
• Life expectancy of greater than or equal to 9 months
• If the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
• Ability to comply with trial requirements and give informed consent.

Exclusion criteria

• IV Bisphosphonate therapy for more than 3 years.
• Patients with a diagnosis of amyloidosis.
• Known hypersensitivity to zoledronic acid or other bisphosphonates
• Pregnant patients or lactating patients.
• Women of childbearing potential not on a medically recognized form of contraception
• Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes mellitus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

15 Minute Infusion

Experimental group

Description:

Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks

Treatment:

Drug: zoledronic acid

30 Minute Infusion

Experimental group

Description:

Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.

Treatment:

Drug: zoledronic acid