Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Newly Diagnosed Multiple Myeloma
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).


Eligibility criteria: Inclusion Criteria:

1. Capable to understand and sign the ICF.
2. Patients aged ≥ 18 years .
3. Patient must have documented multiple myeloma (MM) satisfying the International Myeloma Working Group (IMWG) diagnostic criteria for MM.
4. Newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (ASCT).
5. Patient must have an ECOG performance status score of 0.
6. Patient must have pretreatment clinical laboratory values.
7. Contraceptive use by men or women should be consistent with local regulations.
8. A WOCBP must have a negative serum pregnancy test at screening within 72 hours prior to randomization.

Exclusion Criteria:

1. 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.
2. Patient has plasma cell leukemia or POEMS syndrome .
3. Patient has prior or current systemic therapy or ASCT for MM before randomization.
4. Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher.
5. Patient has a history of malignancy (other than MM) within 3 years before randomization .
6. Patient has clinical signs of meningeal involvement of MM.
7. Patient has known COPD, persistent asthma, or a history of asthma within the last 2 years.
8. Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).
9. Patient is known to have active hepatitis B or C.
10. Patient has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results.
11. Patient has clinically significant cardiac disease.
12. Patient has known allergies, hypersensitivity, or intolerance to treatment drugs.
13. Patient has history of drug abuse or substance abuse.
14. Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes).
15. Patient had radiation therapy within 14 days of randomization.
16. Patient had plasmapheresis within 28 days of randomization.
17. Patient had major surgery within 28 days before randomization.
18. Patient in clinical trials of any other drug or device within 3 months before randomization.
19. Patient has any condition could prevent, limit, or confound the protocol-specified assessments.

Primary outcomes:
measure: IRC-assessed Week 24 rate of very good partial response (VGPR) or better
timeFrame: 24 weeks
Secondary outcomes:
measure: Investigator-assessed Week 24 rate of VGPR or better
timeFrame: 24 weeks
measure: IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better
timeFrame: 12,36,48 weeks
measure: IRC- and investigator-assessed partial response (PR) rate
timeFrame: 48 weeks
measure: IRC- and investigator-assessed complete response (CR) rate
timeFrame: 48 weeks
measure: IRC- and investigator-assessed stringent complete response (sCR) rate
timeFrame: 48 weeks
measure: IRC- and investigator-assessed complete response (CR) or better rate
timeFrame: 48 weeks
measure: IRC- and investigator-assessed overall response rate
timeFrame: 48 weeks
measure: IRC- and investigator-assessed time to response (TTR)
timeFrame: 48 weeks
measure: IRC- and investigator-assessed duration of response (DOR)
timeFrame: 48 weeks
measure: IRC- and investigator-assessed progression free survival (PFS)
timeFrame: 48 weeks
measure: Minimal residual disease (MRD) negative rate
timeFrame: 48 weeks
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30).
timeFrame: 48 weeks
measure: EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire.
timeFrame: 48 weeks
measure: Incidence and severity of adverse events (AEs)
timeFrame: 52 weeks
measure: Time to reach maximum serum drug concentration at steady state (Tmax, ss)
timeFrame: 48 weeks
measure: Time to reach maximum serum drug concentration(Tmax)
timeFrame: 48 weeks
measure: Immunogenicity
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Shanghai
state: Shanghai
Study officials:
References: