Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Musculoskeletal Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Bone Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Density Conservation Agents

All Drugs and Chemicals

Denosumab

Administered by subcutaneous injection once every 4 weeks.

Narlumosbart

Honghui Huang, M.D.

Jian Hou, M.D.

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).

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.

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

Compare narlumosbart and denosumab for percentage change in bone turnover marker (BTM) - urinary N-terminal telopeptide of type 1 collagen (uNTx) corrected for urinary creatinine (uCr) (uNTx/uCr from baseline to week 13)

Compare narlumosbart and denosumab for the proportion of subjects with a change in uNTx/uCr greater than 65% from baseline to week 13 (uNTx/uCr from baseline to week 13 \>65%)

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression.

Percentage of participants with an on-study SRE at 3, 6, 12, 18 and 24 months

Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE.

Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.

Compare the changes of BALP and sCTX-I from baseline to weeks 13

Overall survival was defined as the time interval (in days) from the randomization date to the date of death.

To identify the incidence and the type of AEs, including abnormalities in clinical, laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams.

Shanghai JMT-Bio Inc.

RenJi Hospital

Skin and Connective Tissue Diseases

Bone Neoplasms

Giant Cell Tumors

Giant Cell Tumor of Bone

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms, Bone Tissue

Micronutrients

Vitamins

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Patients will receive narlumosbart 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15 of the first cycle until one of the following occurred: complete tumor resection, disease progression, intolerable toxicity, decision by the patient to discontinue, or decision by the investigator that the patient could no longer benefit from the treatment.

Patients will receive denosumab 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15 of the first cycle until one of the following occurred: complete tumor resection, disease progression without clinical benefit, decision by the patient to discontinue, or decision by the investigator that the patient could no longer benefit from the treatment.

Administered by subcutaneous injection. Dietary Supplement: Calcium/Vitamin D. All patients should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.

Clinical Trials Information Group Officer

Xiaohui Niu, B.M.

This is a phase Ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (JMT103) in patients with unresectable or surgically difficult giant cell tumor of bone (GCTB). This clinical trial study hypothesizes narlumosbart administration groups are not inferior to active control administration groups.

A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone

A Multi-center, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease	NCT06314698	Multiple Myelom... Bone Diseases	Narlumosbart Denosumab	18 Years -	RenJi Hospital
A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone	NCT05813665	Giant Cell Tumo...	Narlumosbart Denosumab	12 Years -	Shanghai JMT-Bio Inc.

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