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ASH 2021 | Reporting patient experiences during the KarMMa trial

Nina Shah, MD, University of California, San Francisco, CA, describes the results from qualitative interviews completed by patients with relapsed and refractory multiple myeloma in the Phase II KarMMa trial (NCT03361748), which assessed idecabtagene vicleucel (ide-cel), a B-cell maturation antigen (BCMA)–directed (chimeric antigen receptor) CAR T-cell therapy. Patients reported an overall positive experience, even if they have no treatment response, mainly due to the convenient, one-time administration of ide-cel. Such questionnaires may lead to optimization of treatments based on quality of life. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.

Transcript (edited for clarity)

This abstract looks at the KarMMa data, but from a different perspective, really qualitative interviews from patients, which is a very uncommon thing explored in a lot of clinical trials. But we were very happy that we were able to do this analysis. As a reminder, the KarMMa trial was a pivotal Phase II trial of… A single arm Phase II trial of bb2121, which is a BCMA directed CAR-T cell therapy for relapsed/refractory multiple myeloma...

This abstract looks at the KarMMa data, but from a different perspective, really qualitative interviews from patients, which is a very uncommon thing explored in a lot of clinical trials. But we were very happy that we were able to do this analysis. As a reminder, the KarMMa trial was a pivotal Phase II trial of… A single arm Phase II trial of bb2121, which is a BCMA directed CAR-T cell therapy for relapsed/refractory multiple myeloma. And we know that patients overall did well with the 73% response rate and in the highest dose, a median PFS of 12 months. We also know from previous analysis that quality of life measures actually either improved or stayed the same, generally improved both from a primary and secondary subscale standpoint. And so it’s very important because this is a one-time treatment and patients’ quality of life can be maintained 6, 9, and 12 months out.

In this particular analysis, we looked at qualitative interviews and really asked patients questions about how they were doing. These are a little bit harder to do because patients have to complete questionnaires and they have to actually give their opinions. And we were able to use some grading to understand the word choices that they use to know if they were doing better, worse, or the same. Interestingly, even for patients who might not have responded, most patients reported a favorable experience with ide-cel. There were a few that reported less favorable, but overall, the majority of patients in the majority of interviews that we had reported a favorable experience with ide-cel. Most of them reported the convenience of a one-time infusion. And if they responded, they reported having a nice duration of response. Even the people who did not respond actually did say that they would do it again, which suggests that it didn’t do any harm. And it was worth for them to try.

Probably a few things that were graded as not so good might have been some infusion reaction and initial toxicities, but those tended to subside several months out so that they were not really mentioned in the later interviews. This is a good study to point out how we should probably be doing qualitative analyses of how patients are doing. And if we can quantify these expressive interviews from patients to understand them better, we will be able to better understand how to differentiate and choose different treatment modalities that might have a better quality of life outcome versus just quantity of life.

 

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