A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080221832

Enrollment

1700

Registered

2012-06-20

Start date

2012-05-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Multiple Myeloma

Interventions

investigational material(s) Generic name etc : Denosumab INN of investigational material : Denosumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Adults with newly diagnosed multiple myeloma -Radiographic evidence of at least 1 bone lesion -Plan to receive primary frontline anti-myeloma therapies -Adequate organ function -Written informed consent

Exclusion criteria

Exclusion criteria: -Nonsecretory multiple myeloma (unless baseline serum free light chain level is elevated) -Plasma cell leukemia -POEMS syndrome -Previous treatment with anti-myeloma therapy -Prior administration of denosumab- -Use of oral bisphosphonates with a cumulative exposure of more than 1 year -More than 1 previous dose of IV bisphosphonate administration -Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw

Design outcomes

Primary

Measure	Time frame
efficacy Time to the first on-study SRE	—

Secondary

Measure	Time frame
efficacy Time to the first-and-subsequent on-study SRE	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026