Daratumumab: COVID-19 Impact – Robert Rifkin – ASH 2022
By Robert Rifkin, MD
What is the Connect® MM Registry and how did COVID-19 impact multiple myeloma Patients? So this is a very interesting study in that it utilizes the Connect Multiple Myeloma Registry (Connect® MM Registry). The registry was established in 2009, and it’s one of the oldest and largest myeloma registries. We recruited (multiple myeloma) patients in 2 cohorts, 1500 (multiple myeloma patients) for the first cohort, followed by another cohort of 1500 (multiple myeloma patients). And what was unique about our registry is over time we’re able to track utilizations and new drugs as they enter the (multiple) myeloma therapeutic realm. So when we first started, it was pretty simple. There were quote novel agents, but then as the registry went forward, we have the emergence of monoclonal antibodies and then all of the newer therapies you’ll hear about at this meeting, whether it be CAR T-cells, bispecific drugs, antibody drug conjugates, or other whole new classes of drugs.
So the exciting part about Connect is not knowing, is it a living, breathing registry, but we were collecting data full force when the pandemic hit and the pandemic, very interesting, as all of it changed utilization of healthcare dramatically. So initially, as everybody just stayed at home, stayed away from offices. A lot of people didn’t really get treated. With the advent of Daratumumab and as we learned how to use it better, you get 8 weekly doses, then 8 every other week doses and then it goes to monthly. And the formulation over the time of the connect registry also went from intravenous to subcutaneous injection. So this becomes extraordinarily convenient for (multiple myeloma) patients and with our newer drugs, we’re able to come up with all oral regimens. So if you can imagine, instead of going every week to the doctor (healthcare professionals), or maybe even twice a week now, you just go in once a month. We validate what you’ve done with your oral medications, do any corrections adjustments, and you get your monthly Daratumumab and back out you go. So I think that was a really beneficial side effect of the pandemic if there is such a thing. It allowed us to make things hopefully more convenient for (multiple myeloma) patients, less toxic and improve adherence and compliance.
What is the Standard of Care for Patients with Multiple Myeloma and Why this Study Matter?
So I think multiple myeloma, it’s very interesting when you ask experts the standard of care, cause I’m not actually sure we’ve all agreed on one. We’re clearly guided by pathways and evidence-based medicine and in newly diagnosed (multiple myeloma) patients, I think we still tend to divide them into transplant eligible and transplant ineligible. But after that, things really shift. So if you ask me what the standard therapy is for myeloma up front you’d get a lot of disagreement amongst experts except to say it’s probably a three-drug combination.
I think with the aid of connect, we’ve been able to track utilization of all the different regimens and there are very many in multiple myeloma and see what’s producing the best results. Least toxic for sure, very active, safe, and increasingly patient convenience becomes a huge factor. If you only have to go for a visit once a month, or it’s a very short visit versus an eight hour infusion, the (multiple myeloma) patients love that. And you have to remember, in our clinics, everybody’s immunosuppressed. And so it’s a vulnerable population. And if we can do things to make it convenient and minimize exposures to covid and all of the other new things we’re discovering that are out there, that’s a win-win for everyone.
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5 Key Takeaways From Connect® MM Registry Study
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The COVID-19 pandemic had a significant impact on the United States’ health care delivery systems (US) (Eg. multiple myeloma patients).
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Connect® MM Registry is a large, multicenter, prospective observational cohort study of newly diagnosed multiple myeloma patients in the United States. Real-world data (RWD) from the Connect MM Registry were analyzed to determine the impact of COVID-19 by comparing pre- and post-COVID-19 baseline characteristics, treatment patterns, and clinical visit rates.
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This research included (multiple myeloma) patients from the Connect MM Registry from two distinct time periods: pre-COVID-19 from January 2018 to February 2020 and during COVID-19 from March 2020 to August 2021.
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At the data cutoff (August 2021), 963 pre- and 637 during-COVID-19 the multiple myeloma participants were still alive and enrolled in the study, respectively.
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Collectively, these findings suggest that COVID-19 may have had an effect on patient treatment, including the frequency of multiple myeloma patient visits and the type of therapy administered.
What is the Trial Design and Why it was Set Up This Way?
So this trial is a little bit unique for those being presented at ASH and that it’s a retrospective registry trial where data collection is ongoing and real time, but always analyzed in a retrospective fashion. So retrospective studies always come under a lot of criticism, oversight, whatever. But in terms of tracking a cohort of (multiple myeloma) patients this large, it would be very difficult to do a prospective randomized control study because that isn’t really what we’re doing here. We’re doing a registry to look at treatment patterns. See what we can tease out and see how we can improve care and practice. Just like the example we pointed out in this abstract, the increasing uptake of Daratumumab without any negative signals. All of the presentations here at ASH will have some kind of a covid footnote. If not, you were asleep at the wheel doing your study and we did not see an increase in covid related deaths, although some occur on just about every study you’ll see at this meeting.
Significant Data On the multiple myeloma Connect® MM Registry Trial
So in a registry that’s always interesting because we do point out study limitations, but I think the significance of the poster that we’re presenting here at ASH was really the uptake utilization of Daratumumab, and there was no detriment to outcome.
Was there a Primary Endpoint on this Study of the Connect® MM Registry?
So in registries, primary endpoints are always difficult. So for the whole registry, it’s hard to define one. Basically, we’re just gonna follow myeloma. But what’s more important is as we mine subsets for this presentation included then we have very specific primary endpoints, secondary endpoints, exploratory endpoints as we analyze the data. So it’s a little bit different than a clinical trial, but each of our sub-studies certainly has a discreet set of endpoints in data collection.
What are the Most Common Questions You are Asked About This Study?
So I think the big ask here is probably Daratumumab data and Daratumumab familiarity. So if you look at when Daratumumab was first released, it was given over the first day as a single infusion, and that often lasted a really long time beyond clinic hours. There were infusion reactions in the next step captured in the registry as we split the dose for the very first dose onto 2 days, adjusted pre-medications, and virtually eliminated the infusion reactions.
And then it became very simple. And while all that was going on within the registry, we were allowed to start tracking the subcutaneous (injection) formulation of Daratumumab. And along with all of these, of course, to take when the drug was released and the treatment patterns where people were using it. And I think the registry’s in a unique position to explore those kinds of things.
And probably the strongest point is if you analyze registry data and compare it with eligibility for randomized clinical trials, probably at most 40% of our (multiple myeloma) patients were eligible for randomized clinical trials. So the registry’s unique, it gave every. A real world evidence glance at what was going on in myeloma and how the drugs and novel agents were being used.
What are the Takeaways from this Data on Daratumumab?
So I think the takeaways from this analysis of registry data showed that Daratumumab, even during the pandemic, could be administered easily. I think when we looked at compliance and adherence, we did not have, once we got started, very many (multiple myeloma) patients missing appointments, and I think for the most part they were compliant with their oral medications because it really became much easier and during the lockdown. You didn’t have to leave your home to get state-of-the-art care.
Robert M. Rifkin, MD, FACP – About The Author, Credentials, and Affiliations
Dr. Rifkin is a board-certified medical oncologist and hematologist at the who specializes in the treatment of blood (cell) malignancies and diseases. His areas of expertise include malignant and benign hematology. He is an expert in coagulation diseases, multiple myeloma, and biosimilars, all of which fall under the purview of his advanced subspecialty training.
Dr. Rifkin adheres to the recommendations established by the National Comprehensive Cancer Network (NCCN) when treating cancer patients. His practice is known as “evidence-based medicine.”