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
Qualifiers
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
Treatments tested in this trial
- Narlumosbart
- Denosumab
Treatment groups
478 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
RenJi Hospital
Lead sponsor
Shanghai JMT-Bio Inc.
Collaborator
Source ClinicalTrials.gov