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CME / ABIM MOC

Multiple Myeloma: Collaborative Interdisciplinary Care in the Management of Ocular Toxicities

  • Authors: Sagar Lonial, MD; Praneetha Thulasi, MD
  • CME / ABIM MOC Released: 9/30/2022
  • Valid for credit through: 9/30/2023
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  • Credits Available

    Physicians - maximum of 0.50 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.50 ABIM MOC points

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

This activity is intended for ophthalmologists, hematologists/oncologists, and other healthcare providers (HCPs) involved in the care of patients with MM.

The goal of this activity is that learners will be better able to manage and mitigate ocular toxicity for therapies used to treat MM and to work as part of an interdisciplinary team to optimize patient outcomes.

Upon completion of this activity, participants will:

  • Have increased knowledge regarding the
    • Ocular toxicities associated with antibody-drug conjugate therapy for MM
  • Have greater competence related to
    • Managing ocular toxicities in patients receiving MM therapies
  • Demonstrate greater confidence in their ability to
    • Collaborate with the interdisciplinary team to manage MM-related ocular toxicity


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Moderator

  • Sagar Lonial, MD

    Department of Hematology and Medical Oncology
    Emory University School of Medicine
    Winship Cancer Institute
    Atlanta, Georgia

    Disclosures

    The opinions expressed are those of Dr Sagar Lonial and do not necessarily reflect the views of Emory University or Emory Healthcare. Dr Lonial’s participation in this activity does not constitute or imply endorsement by Emory University or Emory Healthcare.
    Sagar Lonial, MD, has the following relevant financial relationships:
    Consultant or advisor for: Amgen; Bristol-Myers Squibb; Celgene; Cellectis; GlaxoSmithKline; Janssen; Novartis; Takeda
    Research funding from: CR Therapeutics; Janssen; Novartis; Takeda
    Owns stock (publicly traded) in: TG therapeutics
    Other: Board of Directors for TG Therapeutics

Faculty

  • Praneetha Thulasi, MD

    Section of Cataract, Cornea, External Diseases
    Emory Eye Center
    Emory University School of Medicine
    Atlanta, Georgia

    Disclosures

    The opinions expressed are those of Dr Praneetha Thulasi and do not necessarily reflect the views of Emory University or Emory Healthcare. Dr Thulasi’s participation in this activity does not constitute or imply endorsement by Emory University or Emory Healthcare. Praneetha Thulasi, MD, has no relevant financial relationships. 

Editor

  • Lisa Cockrell, PhD

    Medical Education Director, Medscape, LLC

    Disclosures

    Lisa Cockrell, PhD, has no relevant financial relationships.

Compliance Reviewer

  • Stephanie Corder, ND, RN, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Stephanie Corder, ND, RN, CHCP, has no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has no relevant financial relationships.


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CME / ABIM MOC

Multiple Myeloma: Collaborative Interdisciplinary Care in the Management of Ocular Toxicities

Authors: Sagar Lonial, MD; Praneetha Thulasi, MDFaculty and Disclosures

CME / ABIM MOC Released: 9/30/2022

Valid for credit through: 9/30/2023

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Activity Transcript

Sagar Lonial, MD: Hello, I'm Dr Sagar Lonial at Emory University in Atlanta, Georgia. Welcome to this program titled Multiple Myeloma: Collaborative Interdisciplinary Care in the Management of Ocular Toxicities. Joining me today is Dr Praneetha Thulasi, who is at the Emory Eye Center and also at Emory University School of Medicine in Atlanta. Welcome.

Praneetha Thulasi, MD: Hello.

Dr Lonial: First, let's set the stage a little bit by talking about ocular toxicity in multiple myeloma (MM) patients in general and how some of those patients may manifest. We know, for instance, that there can be orbital involvement or infiltration around the eye that can cause proptosis or bulging of the eyes. There can also be ocular monoclonal gammopathy that can result in damage with the deposition of immunoglobulins in various different portions of the eye as well. And we know that in some situations, there are drug effects that can often impact the eye as well. For instance, bortezomib is known to have chalazia and blepharitis as a potential side effects likely related to the boron in the therapeutic portion of bortezomib.

We know that in any regimen that uses dexamethasone, we can see cataracts and blurred vision, particularly in regimens that use, for instance, carfilzomib or selinexor or dexamethasone in general, particularly since myeloma patients tend to be a little bit older. And more recently, belantamab mafodotin (belamaf) is an antibody drug conjugate that targets the BCMA receptor on the surface of myeloma cells and does, in fact, have ocular adverse events as well. Dr Thulasi, before belantamab came out there, were there things that you would see more frequently or less frequently when it came to ocular issues in myeloma patients?

Dr Thulasi: I think you have highlighted the more common ones very beautifully. I have seen other events like patients who have infections that are very severe because of their immune suppression, or clots in the eye, what we call vein occlusions or arterial occlusions, just because of their cell counts and risk of coagulopathy from their MM. And as a cornea specialist especially, we do worry about monoclonal gammopathy, and I have had a few instances where their presentation of MM was as a monoclonal gammopathy in the eye and then led to the diagnosis of MM. Not very common, but we have seen a lot of these issues before, yes.

Dr Lonial: That is really interesting because it is one of those, we call it MGCS or monoclonal gammopathy of clinical significance, where it may not be a high protein, but you are getting deposition in areas that are of significance, and that leads to the diagnosis of something that ultimately needs therapy. You also did bring up another important group of patients that I did not touch on, which is thrombosis associated with the immunomodulatory (IMiD) class of agents. And we have had patients on IMiD maintenance, particularly lenalidomide, who may have developed a retinal artery occlusion and there is no clear cause for that problem. If they are on IMiD and aspirin is the only prophylaxis, we may either stop IMiD or change their anticoagulation as it could be a side effect of lenalidomide or pomalidomide-based therapy as well.

I think as we get into talking in a little bit more detail about how to manage belamaf and its ocular toxicities, let's spend just a few moments talking about its indication and the history that got belantamab mafodotin up to where it is today. The indication for belamaf is patients with relapsing refractory myeloma who have received at least four prior lines of therapy, including an anti-CD-38 antibody, a proteasome inhibitor, and an immunomodulatory agent. It was approved in 2020 based on the DREAMM-2 clinical trial. The DREAMM-2 trial was a randomized phase 2 study using what had been the recommended phase 2 dose of belamaf at 3.4 mg/kg, compared with a lower dose of 2.5 mg/kg. That was actually a request by the FDA to see whether those ocular events could be reduced in severity or whether that was actually the right dose to recommend overall.

For those of you not familiar with the trial, it was published in Lancet Oncology in 2020. Basically, the median number of prior lines of therapy was 5 to 6 for patients who enrolled in that trial. They were randomized one to one between the two different doses. Patients were treated until progression or adverse events, roughly a hundred patients in each arm. The overall response rate of the 2.5 mg/kg dose, and I am really just going to focus on that because that is the FDA-approved dose, was about 32%, with some patients achieving complete response (CR) and a very good partial response (VGPR). And while the progression-free survival (PFS) was about 3 months, the median duration of response (DOR) was about 11 months.

And I want to put that into perspective when we think about treatments for refractory myeloma. When daratumumab was approved, it had a response rate of about 30% with a DOR of about 9 to 10 months. When carfilzomib was approved, it had a 30% response rate with a DOR of about 9 months. When selinexor was approved, it had about a 25% response rate with a DOR of about 4 months in a PFS of 3 months. So that 30% benchmark has been what we have historically used to establish efficacy in the refractory myeloma patient population.

We also know that the PFS and the overall survival were better for patients who had a partial response (PR) or even a minimal response (MR) or better. That is really important because we know the comparative group of patients who are in this triple class refractory patient population have a median expected overall survival of 9 months and a median PFS of less than 3 months. So certainly, what you are seeing demonstrates significant benefit in that context.

When we look at safety for belamaf in the DREAMM-2 study, and again, I am only going to focus on the 2.5 mg/kg dose because that was what led to the FDA approval, you really see three things that stand out. The first is there was hematologic toxicity. Not surprising given that we are dealing with blood cancer and most things that we do that impact the marrow do have some level of anemia, thrombocytopenia, or neutropenia associated with it. The other thing that was noted is keratopathy, and we are going to spend a lot more time talking about keratopathy in general. If you look at the percentage of patients that had changes in visual acuity of greater than 20/50, only about 30% had greater than or equal to grade 3. In general, that was not a majority of patients overall.

But the other piece of information to look at is that beyond hematologic toxicity and keratopathy, there was very little grade 3 or grade 4 non-hematologic, non-keratopathy toxicity. That is really highlighted in the right side of the left table, where you see maybe 2% or 3% of patients had any other grade ≥ 3 AEs in general. That really is important because what it suggests is that if you can manage the keratopathy, and as people who see patients with myeloma, we are used to the hematologic toxicity, this can be a very easy drug to give.

Looking at another real-life data set that came from the Mayo Clinic is important to look at the clinical use of this drug in practice. If you look at median number of prior lines of therapy, it was 8 in that Mayo Clinic cohort. The median time from diagnosis to belamaf was about 7 years, so certainly later. If you look at the keratopathy incidents, again, most of it was grade 1, grade 2. If you look at absolute percentages, 43% versus 67% in the DREAMM-2 study, if you look at the overall response rate, it was similar, 33% versus 32%. The median PFS was similar. What we do not have is the DOR data because I think that it is really important to understand how to interpret this data overall.

What we do in myeloma is typically say if it is good alone, let's start to combine it. We did that in the ALGONQUIN study, which was a combination of belamaf plus pomalidomide and dexamethasone. What you will notice at the top of this table is different schedules for belamaf (1.9 mg/kg given every 4 weeks, 2.5 mg/kg given every 4 weeks, 2.5 mg/kg given every 8 weeks, or 2.5 mg/kg given every 12 weeks. As you can see that does in some way, have an impact on blurred vision and changes in vision. It appears that perhaps changing to less frequent dosing as part of a combination strategy may be one way to mitigate some of the severity of these ocular events as well.

Dr Thulasi, we have talked a lot about this, and you partnered with us on the phase 2 study and saw patients very early in the development of belamaf. Can you tell us a little bit about how these events may present and some of the subtleties that you noticed in your experience?

Dr Thulasi: These are corneal and ocular side effects like we have never really seen before, and they present with these very interesting little microcysts on the cornea. As you know, the cornea has 5 layers, and the very anterior layer, the epithelium, is where this seems to primarily affect, although there is new data that says it may have some effect even deeper. The changes are very interesting. They look like microcysts. Microcysts are something we are very familiar with as ophthalmologists, but these are not related to any other type of commonly seen microcysts that we know. They are what we call microcyst-like epithelial changes, and usually, they start on the outside, on the periphery of the cornea, and over time, or usually within about couple of infusions or so, we start seeing that these microcysts march closer to the center, and they also disappear in that order. They are usually gone in the periphery first and eventually disappear from the center.

There is somewhat of a correlation with vision. Patients often notice that their visual acuity is reflective of how bad their microcysts are, but we also see that these microcysts cause a change in refraction, a change in prescription. So even though the microcysts are peripheral, patients often look like they have had myopic LASIK sometimes, where they have a very dramatic change in prescription. Functionally the patients can be very blurry, even though when we look at them in the clinic and refract them and get the best vision, they tend to correct it to 20/20.

And in patients in DREAMM-2, the number of patients who have had any sort of microcysts was fairly high, 72% was the number of patients who had any microcysts at all. Most of these patients recovered. The initial median onset was about 37 days, although we have seen patients who had microcysts after the first infusion and all the way up to the third or fourth infusion. Most events were presented by dose 4. The nice thing about these patients, though, is they did get better over time.

Dr Lonial: Let's think a little bit about the outcomes for patients who did develop MECs in the DREAMM-2 study and what that timeframe is, and at the same time, what happens to their myeloma during those periods of dose hold?

Dr Thulasi: So, as we just mentioned, about 69% of patients receiving belamaf had some sort of microcyst or some sort of event by dose 4. The usual median onset of the event was around 37 days. About 25% of this was observed right after the first dose. The good news is most patients recovered from their microcystic changes, and the median time of resolution was about 86.5 days, including those with and without dose modification. About 42 patients, so 44% of patients, had grade ≥ 2 in terms of findings at the time of their discontinuation. About 80% of these recovered with continued follow-up. The peak recovery period was about 2 to 6 months for treatment.

Dr Lonial: I think that is really important because when we think about data from the DREAMM-2 study, what we do know is that during that period of dose hold, 80% of patients actually had improvement in their response or stability in their response. What that really says to me as a clinician is that the half-life may be variable enough that even though you are holding the dose because of the development of keratopathy, the disease is still being kept in check. In fact, those two may go hand in hand. You may have high enough serum levels that it is slower for the keratopathy to reverse. So that is doing 2 things—it is contributing to slower recovery, but at the same time, it is controlling the disease.

I have had many patients in whom we have gone 2 or 3 months without dosing, they did not progress, and ultimately in some of those patients, we adjust the dose and frequency of administration. I know you and I have shared patients that we did not dose every 3 weeks, we dose every 6 weeks, because every time we gave those two back-to-back doses, we saw the development of keratopathy that made us hold, and at least the one I am thinking of was on therapy for over 2 years. So that can be a highly effective strategy as well, certainly not to be afraid of dose holds or dose modifications.

Dr Thulasi: Do you find that there are clusters of patients where you do not even have to have them come back every 3 weeks? That you know they are so predictable that you just see them every 6 weeks or dose them every 6 weeks?

Dr Lonial: I think that is a good question, and it really speaks to what you brought up earlier, which is that the MEC started at the periphery and worked its way back to the middle. So once you understand that a patient may have a grade 2 keratopathy that does not necessarily impact vision but is sufficient enough that we do not want to dose, and we see that every 4-week or every 6-week dosing seems to work, I would not bring them back in the middle. I would just set them on a schedule that may be different just because we know what the tempo is in that one given patient. From my view, I try and get those first 2 doses in 3 weeks apart, just so I can understand whether the drug is working, and if it is working, you are likely to see some level of keratopathy, and then I can begin to explore what the right frequency is depending upon the severity of what you are telling me.

Dr Thulasi: When is the point when you know if the MM is responsive to belamaf? Is that at 3 weeks?

Dr Lonial: By the first 3 weeks one would hope to see some level of stabilization of disease, and then by the second dose, we would hope to see improvement. I think it just depends a little bit on tempo. Recalling that many of these patients are refractory myeloma patients and they do not have many other great options, giving them 2 doses of therapy gives you a sense of what they are going to look like, and that is usually enough time to make a decision. What are some things that you might do in terms of, or recommend to your colleagues, for identifying corneal events in patients receiving belamaf?

Dr Thulasi: The main thing is to not always go by a patient's presenting vision or symptoms. I still think it is very important that they are examined with a slit lamp. The microcysts can also be quite tricky in terms of visualization. It is easiest to see that patient and see those microcysts if it is the same provider seeing them every time. There is a certain pattern to these patients, just like you said, and it is nice if the same provider sees them every time. It is also easier to see the microcysts if the patients have been dilated. What we call the red reflex can really help the visualization of these microcysts. I think the volume of patients is also important. Seeing these belamaf patients over and over again can give a better sense of these microcysts. I often tell my fellows who go in and see these patients before me these are wonderful, very smart, very accomplished fellows, and unless they are looking for pathology, unless they have a sense of where in the infusion dose scale that they are, it is easy to miss some, especially the peripheral microcysts.

The good thing is those are not always clinically relevant. They tend to be grade 1 or less, which we will talk about in a minute. But a very high threshold for these microcysts is often necessary. We see these patients every 3 weeks, usually just before their infusion, within a week before their infusion, as you know. These patients are also examined at their first initial screening exam for any other pathology that we can optimize prior to belamaf infusions. I think if they have a significant cataract if they have an underlying refractive error that we could correct, anything that we can do to optimize them prior to the infusions sets them up somewhat for success.

Dr Lonial: I know when I try and read notes from ophthalmologists, there are lots of abbreviations, and I am just figuring out OS and OD, but I know that KVA and BCVA are also important parts of grading and assessing the severity of toxicity. Can you talk us through that a little bit?

Dr Thulasi: Yes. BCVA stands for best corrected visual acuity. This is very important because a patient may come, and their presenting vision as they are in the world outside may be 20/60, 20/70, but when we refract them, they get down to 20/20. And the scale we use in assessing whether these patients can continue their infusion is based on their best correction, not so much on what their vision is at presentation. That is very important and also clinically significant because even though a patient may be complaining about significantly blurred vision if it is correctable with glasses, they are still okay oftentimes for another infusion.

The KVA scale is a scale we use to assess the degree of these microcysts. The microcysts, as we discussed, can march from the periphery to the center and then disappear in the same order. A patient who has microcysts that are just peripheral is a grade 1. Patients with oftentimes very stable visual acuity, and as those microcysts get closer to the center, their vision often drops, and they tend to march up on the scale to grade 2 or grade 3. Our goal is to never have anybody get to that grade 4. We really want to catch them at grade 2 or 3 and do either dose hold or dose modification to make sure their keratopathy never gets to a severe morbidity point there.

Dr Lonial: I think that it is certainly helpful to understand some of the things that you are looking for in general. The question I always get is how do you manage it, and is there anything you can do to prevent it? Do you have some experience or ideas that you want to share with our audience on those two questions?

Dr Thulasi: The management, unfortunately, is fairly limited. We know artificial tears help. There are two big things that the belamaf seems to be doing to the cornea. One is these microcysts. They tend to be the more visually significant changes. These patients also get fairly dry. They have what we call punctate keratopathy. It is not quite clear what that is from. There are some newer studies that suggest there are maybe some changes to the corneal nerve plexus, and maybe that is leading to decreased tear production. The microcysts are, in some ways, just a wait-and-watch kind of thing. We communicate with you and we reduce or hold the dose, but the dry eyes can be somewhat mitigated. Artificial tears tend to be the mainstay, and our patients are very good after the first few infusions to keep using those tears to mitigate those dry eye symptoms.

We have not had any good robust examination of whether other dry eye therapy or other anti-inflammatories work. We do know we have used steroids, a very important anti-inflammatory, and that did not seem to make any difference in the presentation of dry eye. So it leads us to believe the other medications may not help either. There are anecdotal reports that other dry eye therapies, such as something called a scleral lens, may at least mitigate some of the dry eye symptoms, but again, we need a more robust examination of these patients and therapies. At this point, practically, I think putting every patient on a good dry eye regimen, like artificial tears and hot compresses, and lid scrubs, can be quite helpful in improving their comfort and minimizing dry eye progression.

Dr Lonial: I think that is really helpful. A question that I often get is, are there any preexisting ocular issues or history that we should think twice about putting somebody on belamaf? Contact lens is one that came up in the clinic the other day.

Dr Thulasi :It really is a hard question. We know that any for patient who is monocular, we tend to be nervous because they have much more debilitating symptoms if their vision decreases. Any patient who has severe preexisting dry eye also makes us nervous because their dry eyes tend to get a lot worse on belamaf. We had a handful of patients with Fuchs' dystrophy, corneal dystrophy that also leads to different kinds of microcysts, and those patients on belamaf did not seem to do well. Although, it is not listed as a contraindication. Those are the big ones I know we worry about. From a cornea perspective, if they have large cataracts or macular retinal pathology, those do not seem to necessarily change the infusion protocol or schedule, but it would be great to optimize the retina before we do any sort of belamaf infusion, and if we can do cataract surgery, that would be helpful as well.

Dr Lonial: And what about corneal transplant? That is another one that comes up.

Dr Thulasi: I have personally not had any experience. I do not think, at least based on all the case reports so far, anybody really has had to deal with that either. I know we share a patient who we may have to consider that for, but that has not come up. There are case series out of Maryland where they saw a really interesting pattern of something called limbal stem cell deficiency that suggests maybe there is more permanent damage to the stem cells and more overt damage to the stem cells. But again, it is case series level-based. There are no great trials; we just do not know at this point.

Dr Lonial: That is helpful. I think what you have identified is the really important aspect, which is the multidisciplinary approach to manage not just corneal events but patients getting belamaf in general. Obviously, as the hematologist or oncologist, I want to make sure this is a good option from where the patient is in their treatment cycle. At the same time, I need you or your colleagues to also do the same, to say, "Yes, eye health is sufficiently good enough that we can do this." As you mentioned, having the same person look at the eye over time is probably really important as well.

Again, how that all interacts with our teams, our nurses, our nurse practitioners, and our PAs. I think those are all important aspects of how we do it. Even understanding how to interpret the reports. For example, if it says grade 2 with very few microcysts versus grade 2 with lots of microcysts, that may change how we approach it, especially in the first 2 doses of treatment where we want to understand whether or not the drug works. That partnership I think, has worked really well for us.

Dr Thulasi: I agree, absolutely. Unfortunately, in real life, sometimes these are not as cut and dry as some of these scales make it seem, and absolutely discussing and putting the patient's context in mind is very important. I do not think this is going to be the last time ophthalmologists and oncologists are going to have to collaborate, given the drugs and the pipeline that is coming out. So this is, I think, a very important partnership for patients, but certainly going to be an ongoing partnership, I think, within our specialties.

Dr Lonial: I agree, and I think it has been a really good discussion. We are getting to the end of our time. Do you have any final thoughts on the role of the eyecare professional in managing patients with myeloma on belamaf?

Dr Thulasi: I think it’s important to set expectations, have that partnership, and make sure that the patients understand what to expect so they are not surprised. Oftentimes the ones who have been disappointed or, in my experience, those who have stopped this drug often do so because they had very unrealistic expectations over changes from these microcysts.

Dr Lonial: I will just add a quick few thoughts on the role of the relapsed/refractory MM care team in this context as well. I 100% agree with you that educating patients is really critical to this. What I tell patients is that, at least in my experience, everybody that developed keratopathy, was reversible. I think that is really important because there are some myths floating out there that it can cause permanent blindness or permanent damage. We do not really have large evidence that is, in fact, the case, and even in your early discussions about 70-plus percent of patients had recovery, the reason it is not 100% in that trial is that many of those patients with refractory myeloma, unfortunately, died of myeloma before they had a chance for their vision to correct back to normal. So at least in routine practice, we have not seen that before.

We advise patients not to wear contact lenses during belamaf except when you are doing the special lenses to try and address dry eyes or corneal abrasions. I think the key is that, as you described, very few patients had to discontinue because of grade 4. Actually, a minority of patients developed grade 3 in the DREAMM-2 study as well. So that partnership that we used during the execution of DREAMM-2 really worked, and you need to have that partnership to ultimately be successful.

I think those are great words of wisdom, if you will, for our colleagues listening today. Again, thank you very much for this great discussion, and thank you for participating in this activity. Please continue to answer the questions that follow and complete the post evaluation. Thank you.

This transcript has been edited for style and clarity.

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