Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants (Z-MARK)

Novartis

Status and phase: Completed; Phase 4

Conditions: Multiple Myeloma

Treatments: Drug: zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622505

CZOL446EUS129

Details and patient eligibility

About

This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of multiple myeloma
• Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma
• Stable renal function

Exclusion criteria

• Known sensitivity to bisphosphonates
• Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover
• Current active dental problems
• Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

Zoledronic acid

Experimental group

Description:

Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to \[≥\] 50 nanomoles per millimoles \[nmol/mmol\] creatinine or \<50 nmol/mmol creatinine, respectively).

Treatment:

Drug: zoledronic acid