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Ixazomib plus daratumumab and dexamethasone: Final analysis of a phase 2 study among patients with relapsed/refractory multiple myeloma
S. Delimpasi, MA. Dimopoulos, J. Straub, A. Symeonidis, L. Pour, R. Hájek, C. Touzeau, VK. Bhanderi, JG. Berdeja, P. Pavlíček, JV. Matous, PJ. Robak, K. Suryanarayan, A. Miller, M. Villarreal, D. Cherepanov, JK. Srimani, H. Yao, R. Labotka, RZ. Orlowski
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, klinické zkoušky, fáze II, multicentrická studie
Grantová podpora
Takeda Development Center Americas, Inc. (TDCA), Lexington, MA, USA
NLK
Free Medical Journals
od 1998 do Před 1 rokem
Wiley Free Content
od 1996 do Před 1 rokem
PubMed
38856176
DOI
10.1002/ajh.27382
Knihovny.cz E-zdroje
- MeSH
- dexamethason * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- glycin * analogy a deriváty aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom * farmakoterapie mortalita patologie MeSH
- monoklonální protilátky * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- recidiva MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sloučeniny boru * aplikace a dávkování terapeutické užití škodlivé účinky MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
Novel therapies have improved outcomes for multiple myeloma (MM) patients, but most ultimately relapse, making treatment decisions for relapsed/refractory MM (RRMM) patients increasingly challenging. We report the final analysis of a single-arm, phase 2 study evaluating the oral proteasome inhibitor (PI) ixazomib combined with daratumumab and dexamethasone (IDd; NCT03439293). Sixty-one RRMM patients (ixazomib/daratumumab-naïve; 1-3 prior therapies) were enrolled to receive IDd (28-day cycles) until disease progression/unacceptable toxicity. Median age was 69 years; 14.8% of patients had International Staging System stage III disease; 14.8% had received three prior therapies. Patients received a median of 16 cycles of IDd. In 59 response-evaluable patients, the overall response rate was 64.4%; the confirmed ≥very good partial response (VGPR) rate (primary endpoint) was 30.5%. Rates of ≥VGPR in patient subgroups were: high-risk cytogenetics (n = 15, 26.7%), expanded high-risk cytogenetics (n = 24, 29.2%), aged ≥75 years (n = 12, 16.7%), lenalidomide-refractory (n = 21, 28.6%), and prior PI/IMiD therapy (n = 58, 31.0%). With a median follow-up of 31.6 months, median progression-free survival was 16.8 months (95% confidence interval: 10.1-23.7). Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 54.1% of patients; 44.3% had serious TEAEs; TEAEs led to dose modifications/reductions/discontinuations in 62.3%/36.1%/16.4%. There were five on-study deaths. Any-grade and grade ≥3 peripheral neuropathy occurred in 18.0% and 1.6% of patients. Quality of life was generally maintained throughout treatment. IDd showed a positive risk-benefit profile in RRMM patients and was active in clinically relevant subgroups with no new safety signals.
Clinical Research Takeda Development Center Americas Inc Lexington Massachusetts USA
Colorado Blood Cancer Institute and Sarah Cannon Research Institute Denver Colorado USA
Department of Hematology Medical University of Lodz and Copernicus Memorial Hospital Lodz Poland
Department of Hematology University General Hospital of Patras Patras Greece
Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic
Department of Internal Medicine Hematology University Hospital Prague Czech Republic
Florida Cancer Specialists Tallahassee Cancer Center Tallahassee Florida USA
Global Evidence and Outcomes Lexington Massachusetts USA
Oncology Clinical Research Takeda Development Center Americas Inc Lexington Massachusetts USA
Oncology Takeda Development Center Americas Inc Lexington Massachusetts USA
Sarah Cannon Research Institute Nashville Tennessee USA
Statistics Takeda Development Center Americas Inc Lexington Massachusetts USA
Citace poskytuje Crossref.org
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