Newly Diagnosed Multiple MyelomaPhase 3NCT06895512
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
A Phase 3 study testing HLX15-IV and Darzalex in people with Newly Diagnosed Multiple Myeloma, run by Shanghai Henlius Biotech at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- HLX15-IV and Darzalex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- HLX15-IV, Darzalex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX15-IVDrug
recombinant anti-CD38 human monoclonal antibody injection
DarzalexDrug
recombinant anti-CD38 human monoclonal antibody injection
| Study group | Role | What they receive |
|---|---|---|
| HLX15-IV-Rd | Experimental | HLX15-IV in combination with Lenalidomide-Dexamethasone (Rd) Receives: Drug: HLX15-IV |
| DARZALEX-Rd | Active comparator | DARZALEX in combination with Lenalidomide-Dexamethasone (Rd) Receives: Drug: Darzalex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (17)
Investigator-assessed Week 24 rate of VGPR or better
the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization
Measured: 24 weeks
IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better
percentage of patients achieving VGPR or CR (including sCR) until Week 12, 36 and 48 after the date of randomization
Measured: 12,36,48 weeks
IRC- and investigator-assessed partial response (PR) rate
the percentage of patients achieving PR at any time point after the date of randomization
Measured: 48 weeks
IRC- and investigator-assessed complete response (CR) rate
the percentage of patients achieving CR at any time point after the date of randomization.
Measured: 48 weeks
IRC- and investigator-assessed stringent complete response (sCR) rate
percentage of patients achieving sCR at any time point after the date of randomization
Measured: 48 weeks
IRC- and investigator-assessed complete response (CR) or better rate
the percentage of patients achieving CR or sCR at any time point after the date of randomization.
Measured: 48 weeks
IRC- and investigator-assessed overall response rate
the percentage of patients who achieve PR or better after the date of randomization.
Measured: 48 weeks
IRC- and investigator-assessed time to response (TTR)
the time from the date of randomization to the date of initial documentation of a response (PR or better) for patient who had achieved a response of PR or better
Measured: 48 weeks
IRC- and investigator-assessed duration of response (DOR)
the date of initial documentation of a response (PR or better) to either progressive disease according the IMWG criteria, or death, whichever occurs first
Measured: 48 weeks
IRC- and investigator-assessed progression free survival (PFS)
the duration from the date of randomization to either progressive disease, according to the IMWG response criteria, or death, whichever occurs first.
Measured: 48 weeks
Minimal residual disease (MRD) negative rate
the percentage of patients who achieve negative MRD at least once during the confirmed complete response (CR) or better according to the IMWG response criteria.
Measured: 48 weeks
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30).
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30).Minimum and maximum values is according to the items, the score range of item 1-28 is 1-4, the score range of item 29-30 is 1-7. The higher the overall score is, the better the overall quality of life is.
Measured: 48 weeks
EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire.
EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire.The description of health status is divided into five levels.Health Status Index range is -0.59-1.00, VAS range is 0-100.The higher the Health Status Index and VAS score are, the better the health condition is; the lower the dimension description score is, the fewer problems there are.
Measured: 48 weeks
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0, vital signs and clinical laboratory test results
Measured: 52 weeks
Time to reach maximum serum drug concentration at steady state (Tmax, ss)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: 48 weeks
Time to reach maximum serum drug concentration(Tmax)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: 48 weeks
Immunogenicity
Incidence of ADA and/or NAb for HLX15-IV and DARZALEX
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895512
- Sponsor's protocol ID
- HLX15-IV-NDMM-301
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06895512
- Acronym / sponsor ID
- HLX15-IV-NDMM-301
- Conditions
- Newly Diagnosed Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX15-IV-Rd | Experimental | Drug: HLX15-IVHLX15-IV in combination with Lenalidomide-Dexamethasone (Rd) |
| DARZALEX-Rd | Active comparator | Drug: DarzalexDARZALEX in combination with Lenalidomide-Dexamethasone (Rd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX15-IVrecombinant anti-CD38 human monoclonal antibody injection | Drug | HLX15-IV-Rd |
| Darzalexrecombinant anti-CD38 human monoclonal antibody injection | Drug | DARZALEX-Rd |
Primary outcome
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.
17 secondary outcomes
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
EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire.
Time frame: 48 weeks
Incidence and severity of adverse events (AEs)
Time frame: 52 weeks
Time to reach maximum serum drug concentration at steady state (Tmax, ss)
Time frame: 48 weeks
Time to reach maximum serum drug concentration(Tmax)
Time frame: 48 weeks
Immunogenicity
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HLX15-IV and Darzalex in people with Newly Diagnosed Multiple Myeloma, run by Shanghai Henlius Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IRC-assessed Week 24 rate of very good partial response (VGPR) or better (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.