Treatment Duration and Maintenance Therapy in NDMM

Video

Clinical insights on treatment duration and the decision to place patients with newly diagnosed MM on maintenance therapy.

Transcript:

Ola Landgren, MD, PhD: I was going to ask you, Dennis, about the MAIA trial. We emphasized the importance of the efficacy, and also how feasible and safe it is. It’s well tolerated. Yet patients have to come in for injections, and they also have to keep taking the tablets. So, over time, do patients still go on maintenance, or do they just stay on the 3-drug combination? Is there some scale back in the clinical setting with this 3-drug combination over time?

Dennis Verducci, APRN: It’s a good question. I think that’s on a per-patient basis. If the patient has transportation issues, which some older patients can have, and it’s not feasible for them to get to the infusion center once a month, I think de-escalating to single-agent Revlimid [lenalidomide] would make sense. If the patient has caregivers, or they live close to the infusion center and they’re able to go for their monthly injection of daratumumab, it would be preferable if they stayed on the triplet.

Ola Landgren, MD, PhD: Are there patients who stay on daratumumab as a single agent in the clinic, or do they always have the lenalidomide component to it?

Dennis Verducci, APRN: If the patient has some toxicity with the lenalidomide, we will de-escalate to single-agent daratumumab, and we’ve done that many times in our clinic for many patients.

Ola Landgren, MD, PhD: In your clinic, Ben, do you do continuous therapy with all 3 drugs, or do you scale back? And if you scale back, which of the 2? Or do you do both?

Benjamin Diamond, MD: I try to follow the trial protocol. That calls for continuous therapy with all 3 agents. As you can imagine, especially for frail patients, dexamethasone is usually the first thing to go, and I think that’s fine. Patients are still tolerating things very well, and it’s going to be an individualized approach. Even on the trial itself, there were plenty of patients who were not able to keep up with all 3 drugs and many had to de-escalate, and we still see those incredible outcomes. So I think it’s OK to de-escalate on a per-patient basis.

Ola Landgren, MD, PhD: You said you follow the protocol, and if you look at the paper, the paper uses 3 drugs. But if you go to the New England Journal of Medicine, we know and frequently talk about that there’s supplemental information online. If you download that, you see that the relative dose intensity for lenalidomide is actually 50%, right?

Benjamin Diamond, MD: Correct.

Ola Landgren, MD, PhD: So that means that even on the registrational trial, patients did not get the drugs that were in the protocol. It’s very important to share that perspective for this conversation, for people who listen to it, that we frequently say we stick to the protocol. But when the trial was done, all the patients on average had a 50% reduction. We don’t know, maybe 50% of patients didn’t get lenalidomide, or all the patients got a 50% reduction. We don’t know that. That granularity is not available. What do you think about that?

Benjamin Diamond, MD: Absolutely, and maybe that’s a bit more nuanced as to what I was saying. But yes, as we see, the trial still had the fantastic results that we do see, and that is with all of the dose reductions and the deviations from the protocol for the majority of patients. So if they can do it on the trial, we can do it in our clinics.

Ola Landgren, MD, PhD: Dickran, with regard to monitoring patients over time with this very well-tolerated combination, looking at the laboratory test results, we still see there are drops, for example, in the immunoglobulin G levels. Does that sway you one way or the other? Do you take that into account? Do you give immunoglobulin G, IVIG [intravenous immunoglobulin]? What happens in your clinic?

Dickran Kazandjian, MD: Those are all important issues. I think we all have our own style of extrapolating from the MAIA study. Personally, after about 12 months, I decrease the dose of lenalidomide to about 50%, as you’re referring to, to about 10 mg. Then at 18 months, I usually end up stopping the daratumumab in certain cases.I think it’s important because the MAIA study population tends to be an even older patient population, where I feel like they get a lot of chronic low-grade toxicity from the lenalidomide. And if they’re suffering from that toxicity, then I will flip it around, where I stop the lenalidomide and continue daratumumab as maintenance.

Ola Landgren, MD, PhD: You mentioned the GI [gastrointestinal] toxicity with lenalidomide. I think around 30% [of patients] from many of the larger trials developed loose stools that could even be diarrhea, and many patients are complaining about fecal urgency. They have to run to the bathroom, which limits their possibility of going to the mall or going places in general, visiting friends and family. In our clinic, we frequently also consider using bile acid binders to prevent that. And that is well established. Could you comment briefly on that, Dennis?

Dennis Verducci, APRN: Yes, whenever we’re treating the disease, whether it’s in the induction phase, the consolidation phase, or the maintenance phase, the goal is always to balance quality of life while treating the disease. And one of the more common things we see with lenalidomide, as you mentioned, is loose stools. In our clinic, we tend to give bile acid binders to these patients, which have a significant benefit. After 1 or 2 doses, they’re asymptomatic. It’s really remarkable.

Ola Landgren, MD, PhD: Right.

Transcript edited for clarity.

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