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

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07477587
Phase
PHASE1
Status
Recruiting
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Conditions

  • Multiple Myeloma (MM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLX15-SC-Rd — DRUG
    Subjects will receive 1800 mg HLX15-SC via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).
  • US-DARZALEX FASPRO®-Rd — DRUG
    Subjects will receive 1800 mg US-DARZALEX FASPRO® via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).

Study Details

The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant. Participants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).

Key Dates

Start date
May 27, 2026
Status verified
May 2026
Primary completion
May 25, 2027
Completion
Feb 22, 2028

Study Design

Enrollment
258 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX15-SC-Rd
    HLX15-SC-Rd
  • Active Comparator: US-DARZALEX FASPRO®-Rd
    US-DARZALEX FASPRO®-Rd

Primary Outcome Measure

pharmacokinetic (PK) similarity [ Time Frame: 7 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group, PASpringdaleArkansas72762-
Cancer Specialists of North FloridaJacksonvilleFlorida32256-
D&H National Research CenterMargateFlorida33063-
Ocala Oncology CenterOcalaFlorida34474-
Florida Clinical Trials GroupPlantationFlorida33322-
Florida Clinical Trials GroupTamaracFlorida33321-
Pontchartrain Cancer CenterCovingtonLouisiana70433-
Oncology Consultants (P1 Trials -Exigent Network)HoustonTexas77030-
American Oncology Network Vista Oncology Division / Physician partner associateOlympiaWashington98506-

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Highlands Oncology Group, PA· Springdale, ARCancer Specialists of North Florida· Jacksonville, FLD&H National Research Center· Margate, FLOcala Oncology Center· Ocala, FLFlorida Clinical Trials Group· Plantation, FLFlorida Clinical Trials Group· Tamarac, FL

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