Daratumumab Injection for Multiple Myeloma

This trial explores a new method of administering daratumumab, a drug that targets and destroys abnormal plasma cells in conditions like multiple myeloma and AL amyloidosis. Researchers aim to determine if injecting this medicine in the thigh is as effective and less painful than the usual abdominal injection. Individuals with a confirmed diagnosis of multiple myeloma or AL amyloidosis, who plan to start daratumumab treatment and haven't received it recently, might be suitable candidates. Participants will receive the treatment once a week for eight weeks. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

The trial protocol does not specify if you need to stop your current medications. However, you cannot have had systemic anti-myeloma therapy within 14 days before starting the study drug.

Research has shown that subcutaneous daratumumab is generally well-tolerated by patients. In one study involving patients with high-risk smoldering multiple myeloma, 28% experienced reactions at the injection site. Most reactions were mild, with only a few being moderate.

The FDA has approved daratumumab for treating multiple myeloma and light chain amyloidosis, indicating its safety for humans. While side effects can occur, such as injection site reactions, the drug has proven effective and manageable for many patients.

Daratumumab is unique because it offers a new delivery method for treating multiple myeloma. Unlike traditional intravenous options, daratumumab in this trial is administered subcutaneously, either in the abdomen or the anterior upper thigh, which can potentially offer more convenience and comfort for patients. This method is exciting as it may allow for easier administration and possibly fewer side effects, while maintaining or improving efficacy compared to existing treatments. Researchers are eager to see if these benefits translate into better patient outcomes.

Research has shown that daratumumab effectively treats multiple myeloma, a type of blood cancer. Adding daratumumab to standard treatment reduced the risk of cancer progression or death by nearly 60%. Patients receiving daratumumab as an injection under the skin demonstrated a 52% overall response rate, with benefits lasting over a year on average. This subcutaneous method is also easier and quicker than the traditional intravenous method. In this trial, one group of participants will receive the injection in the thigh, while another group will receive it in the abdomen, to evaluate if thigh administration is as beneficial as abdomen administration.⁶⁷⁸⁹¹⁰