Adjusted Comparison of Outcomes between Patients from CARTITUDE-1 versus Multiple Myeloma Patients with Prior Exposure to PI, Imid and Anti-CD-38 from a German Registry.
Maximilian MerzHartmut GoldschmidtParameswaran HariMounzer AghaJoris DielsFrancesca GhilottiNolen J PerualilaJedelyn CabrietoBenjamin HaefligerHenrik SliwkaJordan M SchecterCarolyn C JacksonYunsi OlyslagerMuhammad AkramTonia NesheiwatLenka KellermannSundar JagannathPublished in: Cancers (2021)
Ciltacabtagene autoleucel (cilta-cel) is a Chimeric antigen receptor T-cell therapy with the potential for long-term disease control in heavily pre-treated patients with relapsed/refractory multiple myeloma (RRMM). As cilta-cel was assessed in the single-arm CARTITUDE-1 clinical trial, we used an external cohort of patients from the Therapie Monitor registry fulfilling the CARTITUDE-1 inclusion criteria to evaluate the effectiveness of cilta-cel for overall survival (OS) and time to next treatment (TTNT) vs. real-world clinical practice. Individual patient data allowed us to adjust the comparisons between both cohorts, using the inverse probability of treatment weighting (IPW; average treatment effect in the treated population (ATT) and overlap population (ATO) weights) and multivariable Cox proportional hazards regression. Outcomes were compared in intention-to-treat (HR, IPW-ATT: TTNT: 0.13 (95% CI: 0.07, 0.24); OS: 0.14 (95% CI: 0.07, 0.25); IPW-ATO: TTNT: 0.24 (95% CI: 0.12, 0.49); OS: 0.26 (95% CI: 0.13, 0.54)) and modified intention-to-treat (HR, IPW-ATT: TTNT: 0.24 (95% CI: 0.09, 0.67); OS: 0.26 (95% CI: 0.08, 0.84); IPW-ATO: TTNT: 0.26 (95% CI: 0.11, 0.59); OS: 0.31 (95% CI: 0.12, 0.79)) populations. All the comparisons were statistically significant in favor of cilta-cel. These results highlight cilta-cel's potential as a novel, effective treatment to address unmet needs in patients with RRMM.
Keyphrases
- multiple myeloma
- clinical trial
- cell therapy
- end stage renal disease
- ejection fraction
- chronic kidney disease
- randomized controlled trial
- acute lymphoblastic leukemia
- type diabetes
- machine learning
- stem cells
- electronic health record
- metabolic syndrome
- study protocol
- mesenchymal stem cells
- diffuse large b cell lymphoma
- bone marrow
- adipose tissue
- climate change
- case report
- open label
- phase ii
- deep learning
- nk cells