|Videos|June 8, 2023

Binod Dhakal, MD, on Assessing Cilta-Cel in Lenalidomide-Refractory Multiple Myeloma

Therapy Status

Carvykti (ciltacabtagene autoleucel)

Johnson & Johnson / Legend Biotech

Approved — r/r myeloma, ≥1 prior line Boxed warnings incl. secondary malignancy As of August 28, 2026

Approved for relapsed/refractory multiple myeloma after at least 1 prior line of therapy (lenalidomide-refractory). Boxed warnings cover CRS, ICANS, Parkinsonism/GBS, HLH/MAS, prolonged cytopenias, immune effector cell-associated enterocolitis (added October 2025), and secondary hematologic malignancies. The CAR-T REMS program was eliminated in June 2025.

  1. February 28, 2022 · FDA approval for r/r multiple myeloma after ≥4 prior lines
  2. April 19, 2024 · Class-wide boxed warning added: secondary T-cell malignancy
  3. June 26, 2025 · FDA eliminates REMS for approved CAR-T therapies
  4. October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis Latest

The associate professor at Medical College of Wisconsin discussed the rationale for the CARTITUDE-4 study and its latest updates.

“In the current practice pattern, there is widespread use of lenalidomide as early as after frontline treatment. And if you look at the real-world data, about 10% of patients are lenalidomide-refractory. And if you look at the clinical trials setting, almost 70% of the patients who are exposed to lenalidomide become refractory. Now based on a study that we performed, we found that this patient population doesn’t do that well, including patients treated with newer therapies.”

Patients with relapsed multiple myeloma after lenalidomide had higher rates of progression-free survival (PFS) after treatment with ciltacabtagene ciloleucel (cilta-cel; Carvykti; Janssen) chimeric antigen receptor (CAR) T-cell therapy compared with standard of care (SOC) therapies, as seen in updated data from the phase 3 CARTITUDE-4 study (NCT04181827).

These data were presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, held June 2-6, in Chicago, Illinois, by Binod Dhakal, MD, associate professor, Medical College of Wisconsin. CGTLive spoke with Dhakal to learn more about the CARTITUDE-4 study and the unmet need that needs to be addressed in the treatment paradigm of patients with lenalidomide-refractory multiple myeloma. He stressed the poor outcomes of these patients and why more novel therapies need to be investigated in the population. He outlined the study design and endpoints, as well as the patient characteristics in both the cilta-cel and SOC arms, which were similar and mostly characteristic of having high-risk disease.

Click here for more coverage of ASCO 2023.

REFERENCE

Dhakal B, Yong K, Harrison SJ, et al. First phase 3 results from CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma. Presented at: ASCO 2023 Annual Meeting; June 2-6; Chicago, Illinois. Abstract #LBA106


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