Integrating the Evidence—The Role of On-Body Injectors in Evolving Multiple Myeloma Care

Explore the broader impact of on-body injection delivery on patient care and practice logistics for patients with multiple myeloma, and review data from the IRAKLIA and IZALCO trials.

To learn more, view the full series: Subcutaneous Solutions: The Evolving Landscape of Drug Administration in Multiple Myeloma Care. 

Dr Beth Faiman: Welcome, everyone. My name is Beth Faiman. I am pleased to share with you this chapter 5, “Integrating the Evidence—The Role of On-Body Injectors in Evolving Multiple Myeloma Care.” With me, I'm joined today by Dr Sikander Ailawadhi and Dr Joseph Mikhael, my esteemed panelists. We will be discussing the OBIs, and hopefully, you've joined us for the previous chapters. We went over the IRAKLIA and the IZALCO studies in detail, and these were non-inferiority studies, so we were just making sure that the SUBQ, IV, OBI devices were similar in terms of efficacy and safety.  

We had similar results to the comparator studies, which was really encouraging. When we're looking at the cross-trial safety results, there were no new red flags, no new safety concerns, but what resonated with me was the lower rate of infusion related reactions that we saw in the IRAKLIA trial, very low-grade as well. We didn't see any in the IZALCO trial, which was the SUBQ versus the On-Body device study. We've had a great rich discussion in the prior chapters. I'd just like to turn it to Dr Mikhael first. What are some of your perspectives on the trials, the IZALCO and the IRAKLIA, and what does this mean to your practice?  

Dr Joseph Mikhael: Well, I mean, I think to me, I look at it in 2 ways, Beth. One, I sort of look at it from the pure Joe science. My name is Joe, we can say that, right? Joe science standpoint. Am I feeling comfortable moving from IV to an OBI in terms of the efficacy of this drug? I am. I'm comfortable with the response rates, duration of the response with concentration studies that have been done. But then there's also just the more pragmatic part, which is I'm even more excited about it, which is both for the patient convenience and frankly for the healthcare resource implications. Going just from IV to SUBQ in many drugs that we've given before, it really cut them out of time that patients were there. It was less of a challenge in patients who may not be able to get good IVs because they've been poked so many times.  

That almost goes without saying. But now I actually feel like, to me, in my mind, Beth, this is like step 3, right? Step 1 was IV, step 2 was SUBQ. This really is a further step. This isn't just a modification of SUBQ. This is really a great opportunity for patients to have a tiny needle, 30-gauge needle, deliver drug in less than 15 minutes overall, in general, in these patients, I'm a little pessimistic in our God Bless American system that we can deliver these at home. I think in other jurisdictions, it may be easier, and maybe with time, we can see that kind of shift. But even if it's not delivered at home, it doesn't have to be delivered in the main classic IV unit. This may be able to be done in a consultation room or another room.  

Dr Joseph Mikhael: So, I think it's going to free up space, it's going to free up nursing time. It's going to shorten the whole patient's experience when they go in and out of the clinic. So, for me, this is sort of a very exciting thing from, as I say, the scientific standpoint makes me comfortable, but I'm even more excited about giving our patients even more of their time back, ideally more of their quality of life with fewer reactions as you've noted, and indeed some health resource implications that hopefully will make our systems more efficient and in my utopic thinking maybe someday even be able to take this at home.  

Dr Beth Faiman: Absolutely. Dr Ailawadhi, we heard in previous chapters, he was very optimistic that this could be given at home where the healthcare system could travel to the patient. I'm still hoping that, too, but just think about if I'm a nurse in the infusion area and I have to give other drugs, drug A, B, and C, and I can just place this on the skin of the patient, push the little device, a little button. We heard early on that 99.9% of the drug was delivered in one of the studies. We can have reassurance that this is actually getting the drug, and I don't have to sit there and push it. Dr Ailawadhi, what are your thoughts on these 2 studies and what it means for our patients and healthcare providers? 

Dr Sikander Ailawadhi: That's an excellent question. See, I come from an institution where everything is extremely SOP driven. You want to do the slightest thing in the institution, you have to refer to the SOP. So, just think of it this way, that to your point, just exactly as you said. The nurse does not have to sit next to the patient pushing the drug. The patient can have their privacy, and they're feeling more kind of human, be with their family member. I do still believe strongly in that at-home administration because the IRAKLIA trial actually did that after cycle 6. When Joe pointed out very well that one of the co-primary endpoints was drug level prior to cycle 6, that was because at the cycle 6 onwards, the patients had an option of choosing this to be given at their home where a nurse would go and administer this. In fact, I've had patients on that trial who got it administered at home, and their feedback was nothing but phenomenal saying that, “Hey, this is just amazing,” that of course on day 1 of the treatment, they had to come in because that was the beginning of the cycle. But on day 15, when they were supposed to come in, the drug went to their home.  

So, it's feasible. To Joe's point, we have to figure out a system. The workflow has really the potential of being revolutionized. The drug delivery system has a potential of being revolutionized. Again, I keep thinking from the standpoint of that patient's psychology, that patient's psyche, the caregiver's thought process. They have cancer. They're dealing with the diagnosis, which as of date, at least, we are saying is not curable. That the patient will have some finite survival with it, but the least we can do is make them feel more human and make them feel more in control of their situation rather than constantly being dependent on the healthcare system. That's a huge step forward.  

Dr Beth Faiman: Such excellent points that you shared with us. I do think that from a practical standpoint, sitting and pushing drugs and chitchatting with the patient, maybe they don't feel like talking or they don't want you in their personal space. Those are real things that we don't actually talk about, but they do come up from time to time. But this on-body injector does have the potential to reduce the clinic time, does have some benefits for the nursing staff and workflow efficiency, less needle sticks, less chair time. As we heard from both of you, the impact on the patient quality of life is huge.  

We heard through the IRAKLIA and the IZALCO studies that patients did prefer the OBI method. Hopefully, we will get these drugs in the home, but until then, we will just have to hope that we can get these in the clinic. With that, I want to thank you, the audience, for listening to the discussion, and absolutely thank Dr Ailawadhi, Dr Mikhael. You did an amazing job in sharing your thoughts and insights, so innovative. My last words to you would be if you didn't visit the earlier chapters, this is chapter 5. We have 1, 2, 3, and 4. So, please listen to the earlier chapters for more detailed discussion on these points. Thank you. 

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Sikander Ailawadhi, MD 
Dr Sikander Ailawadhi is a professor with the Division of Hematology-Oncology at Mayo Clinic in Jacksonville, Florida. His career focus has been on the treatment of plasma cell disorders with core research efforts in understanding the epidemiology and pathophysiology of these disorders and evaluating the benefit of various therapeutic strategies in different populations based on racial-ethnic and socioeconomic diversity. He has worked on the development of novel therapeutics by means of conducting several phase 1 through phase 3 clinical trials for novel drugs, including cellular therapy such as CAR T-cell treatment. Dr Ailawadhi also leads Mayo Clinic’s International Cancer Center and is focused on expanding and implementing the Mayo model of care and vision across the world. 

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Joseph Mikhael MD, MEd, FRCPC, FACP, FASCO 
Dr Joseph Mikhael is a professor in the Clinical Genomics and Therapeutics Division at the Translational Genomics Research Institute (TGen), an affiliate of City of Hope Cancer Center. He is also the chief medical officer of the International Myeloma Foundation (IMF) and director of myeloma research at the HonorHealth Research Institute. He is the principal investigator of many clinical trials, primarily in relapsed multiple myeloma. Dr Mikhael also serves as the treasurer on the executive board of the American Society of Hematology. Dr Mikhael has published over 200 peer-reviewed articles and lectures internationally on a regular basis. He leads the IMF’s diversity efforts, namely the M-Power project in the African American community. He is also the chair of the Diversity, Equity, and Inclusion Council at TGen. Dr Mikhael is heavily involved in training future researchers, mentoring junior faculty, and finding ways to enhance access to novel agents worldwide. 

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Beth Faiman, PhD, MSN, APN-BC, BMTCN, AOCN, FAAN, FAPO 
Dr Beth Faiman is an adult nurse practitioner in the Department of Hematology/Oncology at the Cleveland Clinic, a Case Comprehensive Cancer Center member under the Cancer Prevention, Control, and Population Research Program, and editor-in-chief of the Journal of the Advanced Practitioner in Oncology. She is also the editor of several books and author of numerous chapters and papers. In 2013, Dr Faiman was co-chair of the first Nursing Symposium at the International Myeloma Workshop and subsequent conferences. She has served on the American Board of Internal Medicine Maintenance of Certification Committee and as associate editor of the American Society of Hematology Clinical News. In 2023, Dr Faiman was given the NP/PA Educator of Distinction Award in Multiple Myeloma, and in 2022, she was named the Top NP in Hematology/Oncology and inducted as an inaugural Fellow of Advanced Practice in Oncology. Dr Faiman is a distinguished fellow in the American Academy of Nursing. She remains an active author, presenter, mentor, and educator on hematology, oncology, cellular therapies, and supportive cancer care.