Treating High Risk Smoldering Multiple Myeloma- Aquila Updates | Natalie Callander, MD

My name is Natalie Callandar, and I'm from the University of Wisconsin.

What I'd like to talk about today is the update on what's called the Aquilla, or the Aquila trial, depending on how you like to pronounce that.

This was the largest randomized phase three trial for high-risk smoldering myeloma that's been presented to date. It's about 400 patients.

One of the important things to know about the study is that it is still divided into half getting the drug daratumumab for about three years, and half being on observation.

To be on this trial, you had to meet a special definition of high-risk smoldering myeloma. This included some criteria that may not necessarily be used in the U.S. For example, an IgA monoclonal protein of three grams per deciliter could qualify you, 50 to 60% plasma cells in a bone marrow, and some immunoparesis.

There was some discussion when this was presented at last year's ASH: is that really a high-risk group, not meeting perhaps a very common definition used in the U.S. called the 20, 2, 20 model?

That model refers to individuals who have more than 20% plasma cells in their bone marrow, a free light chain ratio above 20 for the involved over uninvolved, or a monoclonal protein above two grams per deciliter. High risk in that classification is considered two of those three criteria.

Yesterday, Doctor Voorhees updated the Aquila study based on using the 20, 2, 20 criteria. What was very validating for both that scoring system and their data is that the patients who benefited the most were those high-risk smoldering people who had two or more of the 20, 2, 20 criteria, while people who had none actually didn't have any benefit at all.

That's something to keep in mind, especially now with the new FDA approval for daratumumab. We assume more patients may be asked to consider this, but it really looks like this would be something to discuss with your provider. You might ask, “Do I meet that definition? Can you help me understand if I am in that high-risk group?” Because it really looks like that’s where all the benefit is going to be.

If our videos have helped you in any way and you're able to, please consider making a donation to help us continue this important work.

Your gift will go three times as far when we reach $500,000 by the end of the year. Every contribution, big or small, makes a difference, and we're deeply grateful for your support.