NCT06314698

Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease

A Multicenter, Randomized, Controlled, Non-inferiority Study of Narlumosbart Compared With Denosumab in the Treatment of Bone Disease in Patients With Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if narlumosbart is non-inferior to denosumab in the treatment of bone diseases from multiple myeloma (MM).

Detailed description

Multiple myeloma is a plasma cell dyscrasia with a high likelihood of causing bone disease (ie, multiple myeloma-related bone disease); as a result, up to 80% of patients with newly diagnosed multiple myeloma present with osteolytic lesions. Denosumab is recommended for the treatment of newly diagnosed multiple myeloma, and for patients with relapsed or refractory multiple myeloma with evidence of multiple myeloma-related bone disease. Narlumosbart is a recombinant, fully human, anti-receptor activator of nuclear factor kappa-Β ligand (RANKL) IgG4 monoclonal antibody. Changing the IgG2 Fc portion of denosumab to IgG4, results in increased stability, higher specificity and affinity for RANKL than denosumab. The objective of this phase III trial is to compare the efficacy and safety between Narlumosbart and denosumab in patients with bone diseases from newly diagnosed multiple myeloma.

Conditions

• Multiple Myeloma
• Bone Diseases

Interventions

Type	Name	Description
DRUG	Narlumosbart	Administered by subcutaneous injection once every 4 weeks.
DRUG	Denosumab	Administered by subcutaneous injection once every 4 weeks.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-12-31
• Completion: 2027-04-30
• First posted: 2024-03-18
• Last updated: 2024-03-18