Improving Treatment Options for Newly Diagnosed Multiple Myeloma Patients Without Transplants

Recruiting · Phase 1 · Multiple Myeloma (MM) · Arkansas, Florida, Louisiana, Texas and Washington

Check if I qualify View on ClinicalTrials.gov

About this trial

This study looks at two treatments for patients with newly diagnosed multiple myeloma who cannot receive a stem cell transplant. Researchers want to compare the safety and how well these treatments work. Participants will receive either HLX15-SC or DARZALEX FASPRO® in combination with other medicines for four cycles. After the initial treatment, they may continue with the treatment they prefer for up to 32 weeks, based on their health and choice.

The trial is registered under NCT07477587. It is a Phase 1 study, which means it is looking at how safe the treatment is and how well it works. The trial is FDA-regulated and aims to include about 258 participants.

Who can join

Adults 18 years and older can join. This is for men and women who have been diagnosed with multiple myeloma and are not eligible for a transplant. Participants must meet certain health criteria and cannot be pregnant or nursing. The trial team will confirm who is eligible to join.

Condition

Multiple Myeloma (MM)

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly assigned to one of two groups. One group will receive HLX15-SC, and the other will get DARZALEX FASPRO®. Both treatments will be given through injections under the skin for up to 16 weeks. The group receiving HLX15-SC will have weekly injections for the first eight weeks and then every two weeks for the next eight weeks. The same schedule applies for the group receiving DARZALEX FASPRO®.