HLX15-SC

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

What's the purpose of the trial?

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. 

Trial status

Accepting patients

Phase
Phase 1
Enrollment
258
Last Updated

Participating Centers

There are 9 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Lenalidomide is an oral immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.
  • Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
  • Dexamethasone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • HLX15-SC is a type of drug called an anti-CD38 monoclonal antibody. HLX15 is a biosimilar to daratumumab, and being evaluated for use in multiple myeloma.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

DARZALEX FASPRO®-Rd

Accepting patients

HLX15-SC-Rd

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