What are the typical dosages of maintenance therapy? Can they be adjusted?

Maintenance therapy is used to help keep myeloma under control for as long as possible after initial treatment, often with lower intensity dosing. Designed for long term use. For many years, lenalidomide was the gold standard for maintenance therapy. Today, newer options are being added, most notably daratumumab, either alone or in combination. In this video, we'll walk through the typical doses of drugs used in the maintenance setting and explain how they're given over time.

What are the typical dosages of maintenance therapy?

The dosing of daratumumab as a maintenance therapy is the same as that of induction.

It is a flat dose.

It does not change whether it was when you were first diagnosed or after your transplant or during maintenance. So the daratumumab dose will always remain the same.

When you first start Daratumumab, we started a schedule that is a little bit more inconvenient, I suppose, but I equate it to filling up your cup, right? When you are first getting treatment we want to fill your cup up of that medicine, fill you up with that drug that it can really do its job to get to killing.

So in the beginning of daratumumab, the doses start out weekly, where you get one shot per week for eight times or eight weeks. It then transitions to every two weeks, and it's every two weeks for eight times, or a total of four more months. After that initial six months, it transitions into once per month. And this can this process can be interrupted for a transplant and picked up on afterwards,

And we are now, like I've said before, kind of keeping a lid on this thing where now you don't need as much of the buildup of that daratumumab. You just need a maintenance. So you just get one dose of it at that fixed dose once per month, and in theory, indefinitely.

There's some of the trials that have looked at using daratumumab for some fixed duration, whether that's 2 or 3 years, for example, particularly when combined with lenalidomide, and then maybe dropping the daratumumab, continuing on the lenalidomide. But once a month is the dosing of it. Now the lenalidomide is a little more challenging, but maybe a little more flexible we'll say. You know, there are variety of different doses.

And this is very individualized to some degree when patients are first diagnosed. We have a standard dose that we start off with that can be changed based on a patient's, most likely kidney function more than anything else. So let's say the starting dose is 25mg. This is a dose of a pill that you would take for once a day, let's say 2 to 3 consecutive weeks in a row, followed by a week break.

There's been some variety in different trials in terms of the data two weeks or three weeks. But to keep it easy, three weeks is common. So the 21 consecutive days out of 28 days, a one week break. And the point of that break is to do exactly that. Give your body, give your blood levels a break from it to let everything kind of recover so we can get back at killing again next month.

So the dose before transplant, as example is really defined to try and get as high of a dose as we can that your body can safely tolerate, so we can kill as much myeloma as we need to. After a transplant, the purpose of the maintenance lenalidomide is maybe not to kill as much as it is to maintain.

And if that's the case, we don't need as big of a dose. Also, a lot of patients have side effects that they're still recovering from, perhaps after the transplant. And we're not trying here to make people feel worse after a transplant. We're trying to do well by their myeloma.

And so the maintenance starting dose for your average patient with myeloma is about ten milligrams, after a transplant. This usually starts somewhere between 2 to 3 months after the transplant. When we think your body's had adequate time to recover and you're feeling back at it, just finally getting back to life before we say, hey, let's start something back up again. But the lenalidomide dose is about ten milligrams as standard.

Oftentimes this is continued if when given by itself every day, no breaks.

So I think of it as a pill a day to keep the myeloma away. Now if you combine it with something else, you probably need that week break back in there again. Where maybe you do three weeks in a row in a week off. Just to let your body kind of recover from the side effects of having two drugs together that may have some overlapping toxicity.

So ten milligrams is our starting point. Some of the trials had designed it that you do ten milligrams for three months and see how things go. You got brand new baby stem cells in there that are now trying to kind of grow their blood. And here we are kind of putting a little lid on them sometimes as a side effect of it.

Some people develop low blood counts and that need to have their, lenalidomide dose, adjusted. Some people's kidney function may need to be adjusted. Some people have fatigue, some people have diarrhea.

There's lots of different things that, require dose adjustments because our ultimate goal is to keep you on this medicine. So if we can keep you on the drug, we can probably do better by finding a dose that's more tolerable for you.

So the maintenance drugs, the maintenance dose of lenalidomide is one pill per day for either 3 or 4 weeks each month at 10 to 15mg, which is different from the starting dose of 25mg. So we hope it can be tolerable for the longer run.