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
Public ClinicalTrials.gov record NCT07477587. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Parallel-controlled Phase I Study to Compare the Pharmacokinetic 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
Study identification
- NCT ID
- NCT07477587
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Shanghai Henlius Biotech
- Industry
- Enrollment
- 258 participants
Conditions and interventions
Conditions
Interventions
- HLX15-SC-Rd Drug
- US-DARZALEX FASPRO®-Rd Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 26, 2026
- Primary completion
- May 24, 2027
- Completion
- Feb 21, 2028
- Last update posted
- Mar 16, 2026
2026 – 2028
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group, PA | Springdale | Arkansas | 72762 | — |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | — |
| D&H National Research Center | Margate | Florida | 33063 | — |
| Florida Clinical Trials Group | Plantation | Florida | 33322 | — |
| Florida Clinical Trials Group | Tamarac | Florida | 33321 | — |
| Pontchartrain Cancer Center | Covington | Louisiana | 70433 | — |
| Oncology Consultants (P1 Trials -Exigent Network) | Houston | Texas | 77030 | — |
| American Oncology Network Vista Oncology Division / Physician partner associate | Olympia | Washington | 98506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07477587, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2026 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07477587 live on ClinicalTrials.gov.