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Trial Title:
Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease
NCT ID:
NCT06314698
Condition:
Multiple Myeloma
Bone Diseases
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Bone Diseases
Denosumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Narlumosbart
Description:
Administered by subcutaneous injection once every 4 weeks.
Arm group label:
Narlumosbart
Other name:
Narlumosbart Injection, JMT103
Intervention type:
Drug
Intervention name:
Denosumab
Description:
Administered by subcutaneous injection once every 4 weeks.
Arm group label:
Denosumab
Other name:
XGEVA®, AMG 162
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects fully understand and voluntarily participate in this study and sign the
informed consent;
2. Age≥18, no gender limitation;
3. Active multiple myeloma patients with newly diagnosed by International Myeloma
Working Group (IMWG) 2014 criteria;
4. Measurable lesion per at least one of the following criteria : Serum monoclonal
protein ≥10 g/L; Urinary monoclonal protein ≥200 mg/24h; Serum free Light Chain
(FLC) assay showed an involved FLC level ≥100 mg/L with abnormal ratio for FLC
(κ/λ);
5. Radiographic [X-ray, computer tomography (CT), magnetic resonance imaging (MRI),
positons emission tomography coupled with a computer tomography (PET-CT)] evidence
of at least one lytic bone lesion;
6. Plan to receive primary frontline anti-myeloma therapies, or receiving less than one
cycle of frontline anti-myeloma therapy (less than 30 days, does not include
radiotherapy or a single short course of steroid), the treatment regimens were
limited to VRd, D-VRd, DRd, and VCd;
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
8. Adequate organ function, as defined by the following criteria (per laboratory
values):
1. Liver function: Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN),
Serum alanine aminotransferase ≤ (ALT) 2.0 x ULN, Serum aspartate
aminotransferase (AST) ≤ 2.0 x ULN
2. Renal function: Serum creatinine clearance (CrCL) ≥ 30 mL/min, calculated by
the Cockcroft-Gault formula
3. Serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0 mg/dL) and ≤
2.9 mmol/L (11.5 mg/dL)
9. Reproductive potential subjects should be receiving effective contraception (Both
male and female reproductive potential subjects, from the date of signing the
informed consent to 6 months after the end of treatment);
10. Expected survival time ≥ 3 months;
Exclusion Criteria:
1. POEMS syndrome;
2. Plasma cell leukemia;
3. Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw;
Non-healed dental/oral surgery, including tooth extraction; Active dental or jaw
condition which requires oral surgery; Planned invasive dental procedures;
4. Planned radiation therapy or Orthopedic surgery;
5. Prior administration of denosumab or bisphosphonates;
6. Patients with active bone metabolic diseases (Paget disease of bone, Cushing
syndrome and hyperprolactinemia), rheumatoid arthritis, uncontrolled
hyper/hypothyroidism or hyper/hypoparathyroidism;
7. Uncontrolled concurrent diseases, including but not limited to: symptomatic
congestive heart failure, hypertension (blood pressure remains > 150/90 mmHg after
standard therapy), unstable angina, arrhythmia requiring medication or instruments,
history of myocardial infarction within 6 months, echocardiography showing left
ventricular ejection fraction <50%;
8. Active bacterial or fungal infections requiring systemic treatment within 7 days
before randomization;
9. Known infection with human immunodeficiency virus (HIV), active infection with
Hepatitis B virus (positive hepatitis B surface antigen and positive HBV-DNA) or
Hepatitis C virus(positive hepatitis C surface antigen and positive HCV-RNA);
10. Pregnancy (serum β-HCG positive) or lactation;
11. Use of any of the following anti-bone metabolism drugs within 6 months before
enrollment:
1. parathyroid hormonerelated peptides
2. calcitonin
3. osteoprotegerin
4. mithramycin
5. strontium ranelate
12. Known sensitivity to narlumosbart, denosumab, calcium or vitamin D;
13. Any other factors not suitable for participation in this study that in the opinion
of the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai JMT-Bio Inc.
Agency class:
Industry
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06314698