This clinical trial is focused on studying a condition known as high-risk smoldering multiple myeloma, which is a precancerous form of blood cancer that affects the bone marrow. The study is investigating the effects of a treatment called daratumumab, which is administered through an injection under the skin, also known as subcutaneous use. The purpose of the study is to determine if this treatment can help delay the progression of the disease compared to simply monitoring the condition without active treatment.

Participants in the study will receive either the daratumumab treatment or be placed under active monitoring. Active monitoring means that the health of the participants will be regularly checked without giving them the study medication. The study will observe how the body absorbs, distributes, and eliminates the drug, which is known as pharmacokinetics. The trial will last for a period of time, during which participants will be closely monitored to assess the safety and effectiveness of the treatment.

The main goal is to see if daratumumab can prolong the time before the disease progresses to a more serious form, known as multiple myeloma. This is referred to as progression-free survival. The study will help researchers understand if this treatment can offer a better outcome for patients with high-risk smoldering multiple myeloma compared to not receiving the treatment.