Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease

Launched by RENJI HOSPITAL · Mar 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called narlumosbart to see if it is as effective as a commonly used treatment called denosumab for patients with bone problems caused by multiple myeloma, a type of blood cancer. The goal is to find out if narlumosbart can help patients with their bone health as well as denosumab does.

To be eligible for this trial, participants must be at least 18 years old and have active multiple myeloma that meets certain medical guidelines. They should have measurable signs of the disease, including at least one bone lesion visible on imaging tests like X-rays or MRIs. Participants will also need to have good overall health, meaning their organs are functioning well. If you join this study, you will be asked to sign a consent form and may receive either narlumosbart or denosumab while being monitored by the research team. It's important to know that the trial is not yet recruiting participants, so it’s still in the planning stages.

Gender

ALL

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.