Lenalidomide +/- Daratumumab for Multiple Myeloma

(DRAMMATIC Trial)

This trial tests a treatment for multiple myeloma, a cancer affecting plasma cells in the bone marrow. Researchers aim to determine if adding Daratumumab, a monoclonal antibody, to Lenalidomide benefits patients more than using Lenalidomide alone. Participants will be monitored over several years to assess the effectiveness of these treatments. Eligible participants include those who have had multiple myeloma, undergone a stem cell transplant, and completed induction therapy within the last year. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

The trial information does not specify if you need to stop taking your current medications. However, you must not have received any investigational agents within 14 days prior to registration, and you must be able to take DVT prophylaxis (blood clot prevention medication).

Research has shown that lenalidomide is usually well-tolerated by people with multiple myeloma. However, it can increase the risk of blood clots, potentially leading to heart attacks and strokes, especially when combined with medications like dexamethasone. Some patients may also experience lower blood cell counts, increasing the likelihood of infections.

For daratumumab/rHuPH20, studies indicate it can cause serious allergic reactions, such as breathing problems or low blood pressure, though these are uncommon. The most common side effect is an upper respiratory tract infection, similar to a cold.

Researchers are excited about these treatments for multiple myeloma because they combine lenalidomide and daratumumab in a novel way that could enhance patient outcomes. Unlike the standard of care, which often involves lenalidomide alone or with other chemotherapeutic agents, this combination includes daratumumab, a monoclonal antibody that targets CD38 on multiple myeloma cells, potentially improving the immune response against cancer. This dual-action approach not only aims to attack the cancer cells more effectively but also to sustain remission for a longer period. Additionally, daratumumab is delivered subcutaneously with rHuPH20, enhancing patient comfort and convenience compared to intravenous administration. This innovative combination could redefine treatment strategies by offering a more efficient and patient-friendly option.

Studies have shown that lenalidomide, one of the treatments in this trial, can significantly extend the lives of patients with multiple myeloma. In one study, patients taking lenalidomide lived longer than those on other treatments. This trial will also evaluate the combination of lenalidomide with daratumumab, another treatment option in this trial. Research indicates that this combination reduces the number of cancer cells remaining after treatment, achieving minimal residual disease (MRD) negativity. Achieving MRD negativity is linked to better long-term outcomes, suggesting this combination could be very effective for patients with multiple myeloma.⁶⁷⁸⁹¹⁰