NCT06895512 is a Phase 3 clinical trial of HLX15-IV in Newly Diagnosed Multiple Myeloma, sponsored by Shanghai Henlius Biotech.

Who is sponsoring NCT06895512?

NCT06895512 is sponsored by Shanghai Henlius Biotech.

What drugs are being tested in NCT06895512?

Interventions in NCT06895512: HLX15-IV, Darzalex.

What condition does NCT06895512 study?

NCT06895512 studies Newly Diagnosed Multiple Myeloma.

Is NCT06895512 still recruiting?

NCT06895512 is currently not yet recruiting. Last updated 19 March 2025.

Last reviewed 2025-03-19 · How we verify

NCT06895512

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Not yet recruiting Phase 3 Last updated 19 March 2025

What this trial tests

Phase 3 trial testing HLX15-IV in Newly Diagnosed Multiple Myeloma in 386 participants. Not yet recruiting.

Timeline

1 April 2025

Primary endpoint
1 July 2027

1 July 2027

Quick facts

Lead sponsor	Shanghai Henlius Biotech
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	386
Start date	1 April 2025
Primary completion	1 July 2027
Estimated completion	1 July 2027
Sites	1 location across China

Drugs / interventions tested

HLX15-IV — full drug profile →
Darzalex (daratumumab) — full drug profile →

Conditions studied

Newly Diagnosed Multiple Myeloma — all drugs for Newly Diagnosed Multiple Myeloma →

Sponsor

Shanghai Henlius Biotech — full company profile →

Who can join

18 and older, any sex, with Newly Diagnosed Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

IRC-assessed Week 24 rate of very good partial response (VGPR) or better
Time frame: 24 weeks
the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Newly Diagnosed Multiple Myeloma

Currently open trials in the same condition.

NCT06679101 — A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab · Phase 3 · recruiting
NCT06682156 — Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients · recruiting
NCT05259553 — Biomarkers in Multiple Myeloma · NA · recruiting

Other Shanghai Henlius Biotech trials

Trials by the same sponsor.

NCT07518043 — A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors · Phase 1 · not yet recruiting
NCT07477587 — A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in · Phase 1 · not yet recruiting
NCT07533708 — A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours · Phase 1 · not yet recruiting
NCT07484893 — A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects · Phase 1 · not yet recruiting
NCT07495930 — Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06895512 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Henlius Biotech
Last refreshed: 19 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06895512.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing