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
NCT06895512, Phase 3, Not yet recruiting, Shanghai Henlius Biotech
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT06895512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06895512
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT06895512
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 386 participants, estimated
- Lead sponsor
- Shanghai Henlius Biotech
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- HLX15-IV, Darzalex
- First posted
- 2025-03-26
- Last updated
- 2025-03-26
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IRC-assessed Week 24 rate of very good partial response (VGPR) or better | 24 weeks | the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization. |
| Secondary | Investigator-assessed Week 24 rate of VGPR or better | 24 weeks | the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization |
| Secondary | IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better | 12,36,48 weeks | percentage of patients achieving VGPR or CR (including sCR) until Week 12, 36 and 48 after the date of randomization |
| Secondary | IRC- and investigator-assessed partial response (PR) rate | 48 weeks | the percentage of patients achieving PR at any time point after the date of randomization |
| Secondary | IRC- and investigator-assessed complete response (CR) rate | 48 weeks | the percentage of patients achieving CR at any time point after the date of randomization. |
| Secondary | IRC- and investigator-assessed stringent complete response (sCR) rate | 48 weeks | percentage of patients achieving sCR at any time point after the date of randomization |
| Secondary | IRC- and investigator-assessed complete response (CR) or better rate | 48 weeks | the percentage of patients achieving CR or sCR at any time point after the date of randomization. |
| Secondary | IRC- and investigator-assessed overall response rate | 48 weeks | the percentage of patients who achieve PR or better after the date of randomization. |
| Secondary | IRC- and investigator-assessed time to response (TTR) | 48 weeks | 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 |
| Secondary | IRC- and investigator-assessed duration of response (DOR) | 48 weeks | the date of initial documentation of a response (PR or better) to either progressive disease according the IMWG criteria, or death, whichever occurs first |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06895512
GET https://conductscience.org/api/trials/v1/NCT06895512/registered