Status:
NOT_YET_RECRUITING
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Newly Diagnosed Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combinatio...
Eligibility Criteria
Inclusion
- Capable to understand and sign the ICF.
- Patients aged ≥ 18 years .
- Patient must have documented multiple myeloma (MM) satisfying the International Myeloma Working Group (IMWG) diagnostic criteria for MM.
- Newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (ASCT).
- Patient must have an ECOG performance status score of 0.
- Patient must have pretreatment clinical laboratory values.
- Contraceptive use by men or women should be consistent with local regulations.
- A WOCBP must have a negative serum pregnancy test at screening within 72 hours prior to randomization.
Exclusion
- Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- Patient has plasma cell leukemia or POEMS syndrome .
- Patient has prior or current systemic therapy or ASCT for MM before randomization.
- Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher.
- Patient has a history of malignancy (other than MM) within 3 years before randomization .
- Patient has clinical signs of meningeal involvement of MM.
- Patient has known COPD, persistent asthma, or a history of asthma within the last 2 years.
- Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).
- Patient is known to have active hepatitis B or C.
- Patient has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results.
- Patient has clinically significant cardiac disease.
- Patient has known allergies, hypersensitivity, or intolerance to treatment drugs.
- Patient has history of drug abuse or substance abuse.
- Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes).
- Patient had radiation therapy within 14 days of randomization.
- Patient had plasmapheresis within 28 days of randomization.
- Patient had major surgery within 28 days before randomization.
- Patient in clinical trials of any other drug or device within 3 months before randomization.
- Patient has any condition could prevent, limit, or confound the protocol-specified assessments.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT06895512
Start Date
April 1 2025
End Date
July 1 2027
Last Update
March 26 2025
Active Locations (1)
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1
Zhongshan hospital, Shanghai
Shanghai, Shanghai Municipality, China