Phase 4
Completed N=121
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
Source: ClinicalTrials.gov NCT00622505 ↗Enrolled (actual)
121
Serious AEs
39.7%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With ≥1 SRE at the End of 1 Year on Study — 0; 0.17 percentage of participants
◆ Published Evidence
Established
51citations · ~5 / year
Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study.
Summary
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.
Linked Publications
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Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥1 SRE at the End of 1 Year on Study |
0; 0.17 | — |
| SECONDARY Time to First SRE on Study |
NA; NA | — |
| SECONDARY Percentage of Participants Who Experienced Pathologic Bone Fracture |
0.00; 0.07; 0.00; 0.03 | — |
| SECONDARY Percentage of Participants Who Experienced Spinal Cord Compression |
0.00; 0.07; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants Who Experienced Radiation to Bone |
0.00; 0.10; 0.00; 0.11 | — |
| SECONDARY Percentage of Participants Who Experienced Surgery to Bone |
0.00; 0.02; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants Who Experienced HCM |
0.00; 0.02; 0.00; 0.00 | — |
| SECONDARY Skeletal Related Event (SRE) Rate |
0.00; 0.03; 0.00; 0.02 | — |
| SECONDARY Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx) |
19.8; 24.1; 0.2; 4.3; -1.4; -0.5 | — |
| SECONDARY Time to Death |
NA; NA | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00622505) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.