TY - JOUR
T1 - Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment
T2 - Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study
AU - Cohen, Adam D.
AU - Hari, Parameswaran
AU - Htut, Myo
AU - Berdeja, Jesus G.
AU - Usmani, Saad Z.
AU - Madduri, Deepu
AU - Olyslager, Yunsi
AU - Goldberg, Jenna D.
AU - Schecter, Jordan M.
AU - Jackson, Carolyn C.
AU - Gries, Katharine S.
AU - Fastenau, John M.
AU - Valluri, Satish
AU - Deraedt, William
AU - Akram, Muhammad
AU - Crawford, Rebecca
AU - Morrison, Ross
AU - Doward, Lynda
AU - Morgan, Kate
AU - Seldam, Silene ten
AU - Jakubowiak, Andrzej
AU - Jagannath, Sundar
N1 - Funding Information:
This study (ClinicalTrials.gov identifier: NCT03548207 ) was funded by Janssen Research and Development, LLC and Legend Biotech USA Inc . We thank the patients who volunteered to participate in the study, their families and caregivers, the physicians and nurses who cared for the patients and supported this clinical trial, staff members at the 16 study sites in the US who enrolled patients, and staff members who were involved in data collection and analysis. Medical writing support was provided by Niraja Suresh, PhD, of Eloquent Scientific Solutions, and funded by Janssen Global Services, LLC.
Publisher Copyright:
© 2022 The Authors
PY - 2023/1
Y1 - 2023/1
N2 - Introduction: Ciltacabtagene autoleucel (cilta-cel), a novel chimeric antigen receptor T (CAR-T) cell therapy, has demonstrated early, deep, and durable clinical responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), and improvements in health-related quality of life (HRQoL) in CARTITUDE-1 (NCT03548207). Patient perspectives on treatment provide context to efficacy outcomes and are an important aspect of therapeutic evaluation. Methods: Qualitative interviews were conducted in a subset of CARTITUDE-1 patients (n = 36) at screening, Day 100, and Day 184 post cilta-cel on living with MM, therapy expectations, and treatment experiences during the study. Results: Patients most wanted to see change in symptoms with the greatest impact on HRQoL: pain (85.2%) and fatigue (74.1%). The primary treatment expectation was achieving remission (40.7%), followed by extended life expectancy (14.8%). Patients most often defined meaningful change as improvement in symptoms (70.4%) and return to normalcy (40.7%). The percentage of patients reporting symptoms (pain, fatigue, bone fracture, gastrointestinal, neuropathy, and weakness) decreased from 85.2% to 22.2% across symptom types at baseline to 29.2% to 0% on Day 184 after cilta-cel. Improved symptoms and positive sentiments corresponded with improved perception of overall health status and reduced pain level, respectively. Most patients reported that their expectations of cilta-cel treatment had been met (70.8%) or exceeded (20.8%) at Day 184, and 70.8% of patients considered cilta-cel therapy better than their previous treatments. Conclusion: Overall HRQoL improvements and qualitative interviews showed cilta-cel met patient expectations of treatment and suggest the long treatment-free period also contributed to positive sentiments.
AB - Introduction: Ciltacabtagene autoleucel (cilta-cel), a novel chimeric antigen receptor T (CAR-T) cell therapy, has demonstrated early, deep, and durable clinical responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), and improvements in health-related quality of life (HRQoL) in CARTITUDE-1 (NCT03548207). Patient perspectives on treatment provide context to efficacy outcomes and are an important aspect of therapeutic evaluation. Methods: Qualitative interviews were conducted in a subset of CARTITUDE-1 patients (n = 36) at screening, Day 100, and Day 184 post cilta-cel on living with MM, therapy expectations, and treatment experiences during the study. Results: Patients most wanted to see change in symptoms with the greatest impact on HRQoL: pain (85.2%) and fatigue (74.1%). The primary treatment expectation was achieving remission (40.7%), followed by extended life expectancy (14.8%). Patients most often defined meaningful change as improvement in symptoms (70.4%) and return to normalcy (40.7%). The percentage of patients reporting symptoms (pain, fatigue, bone fracture, gastrointestinal, neuropathy, and weakness) decreased from 85.2% to 22.2% across symptom types at baseline to 29.2% to 0% on Day 184 after cilta-cel. Improved symptoms and positive sentiments corresponded with improved perception of overall health status and reduced pain level, respectively. Most patients reported that their expectations of cilta-cel treatment had been met (70.8%) or exceeded (20.8%) at Day 184, and 70.8% of patients considered cilta-cel therapy better than their previous treatments. Conclusion: Overall HRQoL improvements and qualitative interviews showed cilta-cel met patient expectations of treatment and suggest the long treatment-free period also contributed to positive sentiments.
KW - Cilta-cel
KW - HRQoL, Patient expectations
KW - Posttreatment experience
KW - RRMM
UR - http://www.scopus.com/inward/record.url?scp=85143521070&partnerID=8YFLogxK
U2 - 10.1016/j.clml.2022.10.001
DO - 10.1016/j.clml.2022.10.001
M3 - Article
C2 - 36357295
AN - SCOPUS:85143521070
SN - 2152-2650
VL - 23
SP - 68
EP - 77
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 1
ER -