Key points:

• The addition of daratumumab to standard treatment helps patients with myeloma live longer without any exacerbations of cancer
• More patients on the combined treatment had better responses and fewer cancer cells left in their bodies.
• Patients getting daratumumab with standard procedure had a lower risk of their cancer getting worse or dying compared to those getting just the standard treatment alone.
• Serious side effects were slightly more common in patients receiving daratumumab, but both groups had similar severe side effects like low blood cell counts.
• The study shows that adding daratumumab to standard treatment is a good option for these patients.

Introduction:

Myeloma develops when plasma cells, which are infection-fighting blood cells in the immune system, become abnormal and grow and divide uncontrollably, eventually becoming tumors.

When a damaged B cell transforms into an unusual plasma cell, myeloma happens. Myeloma cells are useless in the body, so instead of aiding the immune system in battling illness, they proliferate fast and replace healthy blood cells. 

Low hemoglobin and low platelets, or blood clotting cells, are two conditions that can result from this process over time. Infection risk is higher in myeloma patients due to immune system impairment.

One of the most effective treatments for this is the use of monoclonal antibodies.

A recent study focused on treating this cancer. They studied if using subcutaneous daratumumab with bortezomib, lenalidomide, and dexamethasone (VRd) can help treat patients who can get a transplant and have just been diagnosed with multiple myeloma.

Findings:

Adding subcutaneous daratumumab to the initial and ongoing treatments with VRd and lenalidomide helped transplantation-eligible patients with new multiple myeloma stay without their disease worsening for a significant amount of time. [ref]

Methodology and Analysis:

In this phase 3 trial, 709 patients eligible for stem cell transplantation with newly diagnosed multiple myeloma were randomly assigned to two groups.

One group received subcutaneous daratumumab, VRd induction and consolidation therapy, and lenalidomide maintenance therapy (D-VRd group).

While the other group received only VRd induction and consolidation therapy, along with lenalidomide maintenance therapy (VRd group).

The main aim was to check how long patients remained without their disease getting worse (progression-free survival). This helped researchers compare if adding daratumumab to the usual treatment for multiple myeloma was effective.

After 47.5 months, patients on D-VRd had less disease worsening or death compared to VRd. More D-VRd patients survived without disease progression, achieved complete response, and had MRD-negative status.

Similar severe side effects occurred in both groups.

What is subcutaneous daratumumab?

This is a term used to describe a daratumumab formulation that is injected beneath the skin. Daratumumab, a monoclonal antibody, is a targeted therapy used to treat multiple myeloma, a cancer of the bone marrow plasma cells. 

Daratumumab can be administered subcutaneously and absorbed into the bloodstream more slowly than when administered intravenously, giving patients a practical and efficient treatment option.

Details of VRd therapy:

VRd therapy is a standard treatment regimen for newly diagnosed multiple myeloma. It combines three drugs: bortezomib, lenalidomide, and dexamethasone.

• Dexamethasone reduces inflammation and regulates the immune system when it is overactive, which can be beneficial in cancer treatment.
• Bortezomib stops cancer cells from growing by blocking the proteasomes, the cell's "recycling centers" for proteins.
• Lenalidomide aids the body's immune system in combating cancer by slowing the growth of cancer cells.

Considerations before undergoing a transplant:

1. Consult your doctor about the benefits and drawbacks of various treatments, including autologous stem cell transplantation (ASCT).
2. Some patients, with or without ASCT, who achieve minimal disease levels after treatment can achieve better outcomes.
3. ASCT can lengthen the period of time you are disease-free and enhance your body's reaction to treatment. Medical professionals usually require a significant decrease in myeloma protein levels prior to performing the transplant.
4. Early ASCT can lead to better long-term outcomes, such as minimal disease levels and progression-free survival.
5. Discuss your treatment plan with your physician.  Talk about the possibility of saving your stem cells for a future transplant if an early transplant is not planned. This would allow for a delayed transplant.
6. Early ASCT might be more economical and provide a higher quality of life.

Are you eligible for a transplant?

In the United States, age 65 is no longer the most important factor in determining whether a patient can receive a stem cell transplant for myeloma. Instead, doctors look at a person's overall health and fitness.

Medicare National Coverage Determination doesn't have an upper age limit for transplant coverage. Doctors decide if a patient can have a transplant based on their health and Medicare rules.

A stem cell transplant isn't suitable for everyone with myeloma. Doctors and patients should talk about the risks and benefits, considering the stage of the disease, how aggressive it is, past treatments, and other health factors like age and overall health.

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