Not yet recruiting NCT06895512
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HLX15-IV, Darzalex.
- Who it may be relevant to
- Registry conditions: Newly Diagnosed Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Parallel-controlled, Multicenter, Phase III 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
Overview
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 combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).
Interventions
- Drug HLX15-IV
recombinant anti-CD38 human monoclonal antibody injection - Drug Darzalex
recombinant anti-CD38 human monoclonal antibody injection
Primary outcome measures
- IRC-assessed Week 24 rate of very good partial response (VGPR) or better [Time frame: 24 weeks]
Secondary outcome measures (12)
- Investigator-assessed Week 24 rate of VGPR or better [Time frame: 24 weeks]
- IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better [Time frame: 12,36,48 weeks]
- IRC- and investigator-assessed partial response (PR) rate [Time frame: 48 weeks]
- IRC- and investigator-assessed complete response (CR) rate [Time frame: 48 weeks]
- IRC- and investigator-assessed stringent complete response (sCR) rate [Time frame: 48 weeks]
- IRC- and investigator-assessed complete response (CR) or better rate [Time frame: 48 weeks]
- IRC- and investigator-assessed overall response rate [Time frame: 48 weeks]
- IRC- and investigator-assessed time to response (TTR) [Time frame: 48 weeks]
- IRC- and investigator-assessed duration of response (DOR) [Time frame: 48 weeks]
- IRC- and investigator-assessed progression free survival (PFS) [Time frame: 48 weeks]
- Minimal residual disease (MRD) negative rate [Time frame: 48 weeks]
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30). [Time frame: 48 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan hospital, Shanghai — Shanghai
Identifiers
NCT: NCT06895512 · HLX15-IV-NDMM-301