Trial · NCT07477587
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
NCT07477587, Phase 1, Recruiting, Shanghai Henlius Biotech
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma. Trials, record NCT07477587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07477587
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
- NCT number
- NCT07477587
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 258 participants, estimated
- Lead sponsor
- Shanghai Henlius Biotech
- Conditions
- Multiple Myeloma (MM)
- Interventions
- HLX15-SC-Rd, US-DARZALEX FASPRO®-Rd
- First posted
- 2026-03-17
- Last updated
- 2026-09-24
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pharmacokinetic (PK) similarity | 7 days | Area under the serum concentration-time curve from time 0 to day 7 (AUC0-7d) after the 1st dose. |
| Primary | pharmacokinetic (PK) similarity | 7 days | The maximum (peak) serum drug concentration (Cmax) after the 1st dose. |
| Primary | pharmacokinetic (PK) similarity | 16 weeks | Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 12th dose |
| Primary | pharmacokinetic (PK) similarity | 16 weeks | The maximum (peak) serum drug concentration at steady-state (Cmax,ss) after the 12th dose |
| Secondary | PK characteristics | 16 weeks | trough concentration (Ctrough) |
| Secondary | PK characteristics | 16 weeks | trough concentration at steady state (Ctrough,ss). |
| Secondary | Safety: Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) | 16 weeks | Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) terms and frequency of occurrence judged by investigators |
| Secondary | Safety: Vital Signs | 16 weeks | Vital Signs: including blood pressure (systolic and diastolic; mmHg) , pulse rate (beats/min) measured by hematomanometer |
| Secondary | Safety: Vital Signs | 16 weeks | including body temperature (°C) measured by clinical thermometer |
| Secondary | Safety: Physical examinations | 16 weeks | Physical examinations: includes general condition; head and neck; mucous membranes; chest; abdomen; spine; extremities; musculoskeletal system; neurological system; lymphatic system; and skin checked by investigators |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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/NCT07477587
GET https://conductscience.org/api/trials/v1/NCT07477587/registered?page=2