PMID- 34885106
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211214
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 13
IP  - 23
DP  - 2021 Nov 29
TI  - 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.
LID - 10.3390/cancers13235996 [doi]
LID - 5996
AB  - 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.
FAU - Merz, Maximilian
AU  - Merz M
AD  - Cell Therapy and Hemostaseology, Department of Hematology, University Hospital of 
      Leipzig, 04103 Leipzig, Germany.
FAU - Goldschmidt, Hartmut
AU  - Goldschmidt H
AUID- ORCID: 0000-0003-0961-0035
AD  - Internal Medicine V and National Center for Tumor Diseases, University Clinic 
      Heidelberg, 69120 Heidelberg, Germany.
FAU - Hari, Parameswaran
AU  - Hari P
AD  - Medical College of Wisconsin, Milwaukee, WI 53226, USA.
FAU - Agha, Mounzer
AU  - Agha M
AD  - School of Medicine, University of Pittsburgh, Pittsburgh, PA 15213, USA.
FAU - Diels, Joris
AU  - Diels J
AUID- ORCID: 0000-0002-9456-9120
AD  - Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
FAU - Ghilotti, Francesca
AU  - Ghilotti F
AD  - Janssen-Cilag SpA, 20093 Cologno Monzese, Italy.
FAU - Perualila, Nolen J
AU  - Perualila NJ
AD  - Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
FAU - Cabrieto, Jedelyn
AU  - Cabrieto J
AD  - Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
FAU - Haefliger, Benjamin
AU  - Haefliger B
AUID- ORCID: 0000-0002-7802-0883
AD  - Cilag GmbH International, 6300 Zug, Switzerland.
FAU - Sliwka, Henrik
AU  - Sliwka H
AD  - Janssen-Cilag Pharma GmbH, 1020 Vienna, Austria.
FAU - Schecter, Jordan M
AU  - Schecter JM
AD  - Janssen R&D, Raritan, NJ 08869, USA.
FAU - Jackson, Carolyn C
AU  - Jackson CC
AD  - Janssen R&D, Raritan, NJ 08869, USA.
FAU - Olyslager, Yunsi
AU  - Olyslager Y
AD  - Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
FAU - Akram, Muhammad
AU  - Akram M
AD  - Legend Biotech USA, Inc., Piscataway, NJ 08854, USA.
FAU - Nesheiwat, Tonia
AU  - Nesheiwat T
AD  - Legend Biotech USA, Inc., Piscataway, NJ 08854, USA.
FAU - Kellermann, Lenka
AU  - Kellermann L
AD  - Oncology Information Service (O.I.S), 79098 Freiburg, Germany.
FAU - Jagannath, Sundar
AU  - Jagannath S
AD  - Mount Sinai Medical Center, New York, NY 10029, USA.
LA  - eng
PT  - Journal Article
DEP - 20211129
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC8656798
OTO - NOTNLM
OT  - CAR-T
OT  - CARTITUDE-1
OT  - adjusted comparison
OT  - chimeric antigen receptor T-cell therapy
OT  - cilta-cel
OT  - ciltacabtagene autoleucel
OT  - indirect treatment comparison
OT  - relapsed or refractory multiple myeloma
COIS- The authors declare the following conflicts of interest: M.M.: BMS (consulting or 
      advisory role, travel, accommodations, expenses), Amgen (consulting or advisory 
      role, travel, accommodations, expenses), Takeda (consulting or advisory role, 
      research funding, travel, accommodations, expenses), Celgene (travel, 
      accommodations, expenses), Abbvie (travel, accommodations, expenses), Janssen 
      (consulting or advisory role, travel, accommodations, expenses). H.G.: Adaptive 
      Biotechnology (Advisory Board), Amgen (Grants and/or provision of Investigational 
      Medicinal Product, Research Support, Advisory Board, Honoraria), BMS (Grants 
      and/or provision of Investigational Medicinal Product, Research Support, Advisory 
      Board, Honoraria), Celgene (Grants and/or provision of Investigational Medicinal 
      Product, Research Support, Advisory Board, Honoraria), Chugai (Grants and/or 
      provision of Investigational Medicinal Product, Research Support, Honoraria), 
      Dietmar-Hopp-Foundation (Grants and/or provision of Investigational Medicinal 
      Product), GSK (Honoraria), Janssen (Grants and/or provision of Investigational 
      Medicinal Product, Research Support, Advisory Board, Honoraria), Incyte (Research 
      Support), Johns Hopkins University (Grants and/or provision of Investigational 
      Medicinal Product), Molecular Partners (Research Support), MSD (Research 
      Support), Mundipharma GmbH (Research Support), Novartis (Research Support, 
      Honoraria), Sanofi (Grants and/or provision of Investigational Medicinal Product, 
      Advisory Board, Honoraria), Takeda (Research Support, Advisory Board). P.H.: BMS 
      (Honoraria for Consulting), Takeda (Honoraria for Consulting), Janssen (Honoraria 
      for Consulting), Amgen (Honoraria for Consulting), Karyopharm (Honoraria for 
      Consulting/Speaking), GSK (Honoraria for Consulting). M.A. (Mounzer Agha).: No 
      Relationships to Disclose. J.D., F.G., N.J.P., J.C., B.H., H.S., J.M.S., C.C.J., 
      Y.O.: Employees of Janssen or its subsidiaries. C.C.J.: Employee of Janssen and a 
      consultant physician at the Memorial Sloan Kettering Cancer Center (New York, NY, 
      USA). L.K.: Amgen (Research Support, Grant), Astellas (Research Support, Grant), 
      BMS (Research Support, Grant), Celgene (Research Support, Grant), GSK (Research 
      Support, Grant), Janssen (Research Support, Grant), Merck (Research Support, 
      Grant), OncoPeptides (Research Support, Grant), Sanofi (Research Support, Grant), 
      Takeda (Research Support, Grant). M.A. (Muhammad Akram)., T.N.: Employees of 
      Legend Biotech USA, Inc. S.J.: BMS (Consulting or Advisory Role, Travel, 
      Accommodations, Expenses), Janssen (Consulting or Advisory Role, Travel, 
      Accommodations, Expenses), Karyopharm Therapeutics (Consulting or Advisory Role, 
      Travel, Accommodations, Expenses), Legend Biotech (Consulting or Advisory Role, 
      Travel, Accommodations, Expenses), Sanofi (Consulting or Advisory Role), Takeda 
      (Consulting or Advisory Role).
EDAT- 2021/12/11 06:00
MHDA- 2021/12/11 06:01
PMCR- 2021/11/29
CRDT- 2021/12/10 01:05
PHST- 2021/09/20 00:00 [received]
PHST- 2021/11/12 00:00 [revised]
PHST- 2021/11/22 00:00 [accepted]
PHST- 2021/12/10 01:05 [entrez]
PHST- 2021/12/11 06:00 [pubmed]
PHST- 2021/12/11 06:01 [medline]
PHST- 2021/11/29 00:00 [pmc-release]
AID - cancers13235996 [pii]
AID - cancers-13-05996 [pii]
AID - 10.3390/cancers13235996 [doi]
PST - epublish
SO  - Cancers (Basel). 2021 Nov 29;13(23):5996. doi: 10.3390/cancers13235996.