Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects fully understand and voluntarily participate in this study and sign the informed consent;
Age≥18, no gender limitation;
Active multiple myeloma patients with newly diagnosed by International Myeloma Working Group (IMWG) 2014 criteria;
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);
Disqualifiers
POEMS syndrome;
Plasma cell leukemia;
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;
Planned radiation therapy or Orthopedic surgery;
Trial design
Design model
Parallel
Treatments tested in this trial
Narlumosbart
DrugAdministered by subcutaneous injection once every 4 weeks.
Denosumab
DrugAdministered by subcutaneous injection once every 4 weeks.
Treatment groups
478 Participants
are divided into 2 treatment groupsGroup A: NarlumosbartExperimental treatment 1 intervention
Group B: DenosumabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent change from baseline in urinary N-terminal telopeptide of type 1 collagen corrected for urinary creatinine (uNTx/uCr) at week 13
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)
Time frame
From baseline to week 13Secondary outcomes
1
The proportion of subjects with a change in uNTx/uCr greater than 65% 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%)
Time frame
From baseline to week 132
Time to first on-study skeletal related event
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
Time frame
From baseline to 90 days after the last dose, up to approximately 30 months3
Percentage of participants with an on-study SRE at different time points
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 frame
Months 3, 6, 12, 18 and 244
Time to first and subsequent on-study SRE
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.
Time frame
From baseline to 90 days after the last dose, up to approximately 30 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Shanghai JMT-Bio Inc.
Collaborator
Source ClinicalTrials.gov
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