Assessing FDA-Approved CAR-T in Patients With Multiple Myeloma and Renal Failure

Bristol Myers Squibb (BMS) and 2seventybio’s idecabtagene vicleucel (ide-cel; marketed as Abecma) and Janssen and Legend Biotech’s ciltacabtagene autoleucel (cilta-cel; marketed as Carvykti) are the 2 chimeric antigen receptor T-cell (CAR-T) therapies currently approved by the FDA for the treatment of relapsed/refractory multiple myeloma (r/r MM). Notably, however, there are some differences between the eligibility criteria that were used for participation in the clinical trials for these products and the population of patients that are now eligible for treatment in the real-world. For example, patients with renal failure were excluded from participation in the trials, but may be treated with the commercial product.

At the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 6 to 9, 2025, in Orlando, Florida, CGTLive® spoke to Deevyashali Parekh, MBBS, an internal medicine resident at SUNY Upstate Medical University Hospital, who had presented a retrospective, real-world study comparing patients with renal failure who received treatment with the r/r MM CAR-T products in the real-world against those without renal failure. Parekh went over the key findings of the study and also noted some potential avenues of further study that may help address outstanding questions.

CGTLive: Can you give some background context about your presentation?

Deevyashali Parekh, MBBS: The research that we did was on the the effect of giving CAR-T therapy in patients with r/r MM who also had severe renal impairment. The idea behind the project is that the pivotal trials for which CAR-T was approved in this patient population actually excluded patients with severe renal dysfunction so we don't actually have data available to see whether these treatments are safe in this patient population. However, a lot of times clinicians use their clinical judgment and they tend to use this in patients even if they don't meet that criteria. So we use a database study which allowed us to get a little bit of a decent population number, and we wanted to see if giving CAR-T in this population kind of affected overall survival. Did they have more adverse effects? That was the idea behind it.

What are some of the key findings you presented?

One of the most important results was that with both CAR-T products, patients did not have a significantly different outcome. There was no change in overall survival, no change in median overall survival, or deaths, which is awesome. One of the important things that we were concerned about was adverse effects because that's what we thought—that the product would accumulate and cause toxicity. But cytokine release syndrome of any grade and immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was not different at all. Thirty-day cytopenias (which is anemia, thrombocytopenia, and leukopenia) was also not different, which was surprising.

Even though there's a lot of limitations of a database study, I think it allows us to get a decent number of an end for a study like this, to suggest that at least it might be safe and still effective in this patient population. Hopefully we see actual prospective data on this.

How would you summarize the big-picture implications that doctors and the broader healthcare community should take away from this new data?

I think the big picture implications are that, of course, clinician judgment to see what's the most suitable patient population is still the most important thing. However, just a certain number, like the creatinine or GFR shouldn't preclude patients from being able to get these really good therapies that we have for myeloma, especially if they have a good performance status and are functionally still doing really well. I think that's the big takeaway, that clinical judgment would be the most important thing about giving these treatments, and not the number for renal function.

Are there any unanswered questions with these findings?

I think one of the most important questions that we wanted to identify, but were unable answered from a database study [was when] we took a patient population that had severe renal dysfunction and dialysis, and we wanted to see how they would do—I think a very important data point would be to see how many actually progressed in the renal dysfunction—even if they didn't have adverse effects from the treatment itself—did they progress in further stages of CKD? Was there an increase in the number of patients who needed dialysis at the end? That would be a really interesting data point to look at.

Is there anything else you want to add?

There's a lot of studies kind of in this avenue here at ASH. People are looking at bispecific antibodies in the same regard, CAR-T therapy in the same regard... I think we're entering an age where cellular therapy is probably the most effective therapy for a lot of hematologic malignancies, especially MM, and expanding the indications and the treatment population that we can use it for I think is super treatment-relevant.

This transcript has been edited for clarity.

For more coverage of ASH 2025, click here.

REFERENCE
1. Parekh D. Real-world outcomes with CAR-T therapy in relapsed/refractory multiple myeloma and severe renal failure: A propensity matched multi-center retrospective Study using trinetx database. Presented at: ASH 2025 Annual Meeting. December 6-9, 2025; Orlando, FL. Abstract #4593