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

NCT06895512 | Not Yet Recruiting Phase 3

• 1 other identifier: HLX15-IV-NDMM-301
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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).

Conditions

Newly Diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• IRC-assessed Week 24 rate of very good partial response (VGPR) or better

  the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization.

  24 weeks

Secondary Outcomes (17)

• Investigator-assessed Week 24 rate of VGPR or better

  24 weeks

• IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better

  12,36,48 weeks

• IRC- and investigator-assessed partial response (PR) rate

  48 weeks

• IRC- and investigator-assessed complete response (CR) rate

  48 weeks

• IRC- and investigator-assessed stringent complete response (sCR) rate

  48 weeks

Study Arms (2)

HLX15-IV-Rd

EXPERIMENTAL

HLX15-IV in combination with Lenalidomide-Dexamethasone (Rd)

Drug: HLX15-IV

DARZALEX-Rd

ACTIVE COMPARATOR

DARZALEX in combination with Lenalidomide-Dexamethasone (Rd)

Drug: Darzalex

Interventions

HLX15-IV DRUG

recombinant anti-CD38 human monoclonal antibody injection

HLX15-IV-Rd

Darzalex DRUG

recombinant anti-CD38 human monoclonal antibody injection

DARZALEX-Rd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Zhongshan hospital, Shanghai

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

daratumumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)