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Multiple MyelomaPhase 3NCT06314698

Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease

A Phase 3 study testing Narlumosbart and Denosumab in people with Multiple Myeloma and Bone Diseases, run by RenJi Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Bone Diseases
What is being tested?
Narlumosbart and Denosumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
478 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 30 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
  • 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;
  • 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;
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Adequate organ function, as defined by the following criteria (per laboratory values):
  • 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
  • Renal function: Serum creatinine clearance (CrCL) ≥ 30 mL/min, calculated by the Cockcroft-Gault formula
  • Serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
  • 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);
  • Expected survival time ≥ 3 months;

Who cannot join

  • 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;
  • Prior administration of denosumab or bisphosphonates;
  • Patients with active bone metabolic diseases (Paget disease of bone, Cushing syndrome and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper/hypothyroidism or hyper/hypoparathyroidism;
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  • 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%;
  • Active bacterial or fungal infections requiring systemic treatment within 7 days before randomization;
  • 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);
  • Pregnancy (serum β-HCG positive) or lactation;
  • Use of any of the following anti-bone metabolism drugs within 6 months before enrollment:
  • parathyroid hormonerelated peptides
  • calcitonin
  • osteoprotegerin
  • mithramycin
  • strontium ranelate
  • Known sensitivity to narlumosbart, denosumab, calcium or vitamin D;
  • Any other factors not suitable for participation in this study that in the opinion of the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Honghui Huang, M.D. contact

00862168383141

honghui_huang@163.com

About this study

Official title: A Multicenter, Randomized, Controlled, Non-inferiority Study of Narlumosbart Compared With Denosumab in the Treatment of Bone Disease in Patients With Multiple Myeloma

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).

Read the 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.

Being tested
Narlumosbart, Denosumab
Medical subject headings
Multiple Myeloma, Bone Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NarlumosbartDrug

    Also called Narlumosbart Injection, JMT103

    Administered by subcutaneous injection once every 4 weeks.

  • DenosumabDrug

    Also called XGEVA®, AMG 162

    Administered by subcutaneous injection once every 4 weeks.

Study groups in NCT06314698
Study groupRoleWhat they receive
NarlumosbartExperimental120 mg SC Q4W, up to 2 years.
Receives: Drug: Narlumosbart
DenosumabActive comparator120 mg SC Q4W, up to 2 years.
Receives: Drug: Denosumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: From baseline to week 13

Secondary outcomes (7)

  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%)

    Measured: From baseline to week 13

  2. 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

    Measured: From baseline to 90 days after the last dose, up to approximately 30 months

  3. 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

    Measured: Months 3, 6, 12, 18 and 24

  4. 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.

    Measured: From baseline to 90 days after the last dose, up to approximately 30 months

  5. Percent changes of serum bone alkaline phosphatase (BALP) and serum C-terminal telopeptide of type 1 collagen (sCTX-I)

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

    Measured: From baseline to week 13

  6. Overall Survival

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

    Measured: From baseline to 90 days after the last dose, up to approximately 30 months

  7. Incidence and type of adverse events (AEs)

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

    Measured: From the first dose finished to 28 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
478 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06314698
Sponsor's protocol ID
IIT-2024-0011
Status last verified
Mar 2024
First submitted
10 Mar 2024
Last updated
18 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dhillon S. Narlumosbart: First Approval. Drugs. 2024 Jan;84(1):105-109. doi: 10.1007/s40265-023-01985-3.

    PubMed 38112898

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Narlumosbart and Denosumab in people with Multiple Myeloma and Bone Diseases, run by RenJi Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Honghui Huang, M.D. (00862168383141, honghui_huang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in urinary N-terminal telopeptide of type 1 collagen corrected for urinary creatinine (uNTx/uCr) at week 13 (time frame: From baseline to week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06314698, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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