An open-label phase 2 study treating patients with first or second relapse of multiple myeloma with carfilzomib, pomalidomide, and dexamethasone (KPd) : SELECT study
Once-weekly carfilzomib at 56 mg/m2 plus immunomodulatory drugs and dexamethasone has shown efficacy and tolerability treating early relapsed/refractory multiple myeloma (RRMM). The phase 2 SELECT study (NCT04191616) evaluated efficacy/safety of weekly carfilzomib, pomalidomide, and dexamethasone (KPd) in early RRMM patients refractory to lenalidomide. All 52 treated patients were refractory to prior treatment, and 19 (37%) were triple-class refractory. Overall response rate (ORR; primary endpoint) was 58% (35% ≥ very good partial response, 6% ≥ complete response); median response duration was 20.3 months. Minimal residual disease negativity (10-5) was achieved in 10% of patients. Median progression-free survival was 11.1 months; median overall survival was 18.8 months. Adverse events (AEs) were consistent with the known safety profile including grade ≥3 treatment-emergent AEs reported in 67% of patients. Although the primary endpoint of ORR was not met, KPd showed meaningful clinical benefits in lenalidomide-refractory RRMM patients, including those who were daratumumab-refractory and/or triple-class refractory.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Leukemia & lymphoma - (2024) vom: 18. März, Seite 1-10 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Perrot, Aurore [VerfasserIn] |
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| Links: |
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| Themen: |
Carfilzomib |
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| Anmerkungen: |
Date Revised 04.04.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1080/10428194.2024.2322030 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369872223 |
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| 245 | 1 | 3 | |a An open-label phase 2 study treating patients with first or second relapse of multiple myeloma with carfilzomib, pomalidomide, and dexamethasone (KPd) |b SELECT study |
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| 520 | |a Once-weekly carfilzomib at 56 mg/m2 plus immunomodulatory drugs and dexamethasone has shown efficacy and tolerability treating early relapsed/refractory multiple myeloma (RRMM). The phase 2 SELECT study (NCT04191616) evaluated efficacy/safety of weekly carfilzomib, pomalidomide, and dexamethasone (KPd) in early RRMM patients refractory to lenalidomide. All 52 treated patients were refractory to prior treatment, and 19 (37%) were triple-class refractory. Overall response rate (ORR; primary endpoint) was 58% (35% ≥ very good partial response, 6% ≥ complete response); median response duration was 20.3 months. Minimal residual disease negativity (10-5) was achieved in 10% of patients. Median progression-free survival was 11.1 months; median overall survival was 18.8 months. Adverse events (AEs) were consistent with the known safety profile including grade ≥3 treatment-emergent AEs reported in 67% of patients. Although the primary endpoint of ORR was not met, KPd showed meaningful clinical benefits in lenalidomide-refractory RRMM patients, including those who were daratumumab-refractory and/or triple-class refractory | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Carfilzomib | |
| 650 | 4 | |a EudraCT 2019-001169-34 | |
| 650 | 4 | |a NCT04191616 | |
| 650 | 4 | |a lenalidomide refractory | |
| 650 | 4 | |a pomalidomide | |
| 650 | 4 | |a relapsed/refractory multiple myeloma | |
| 650 | 4 | |a triple-class refractory | |
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| 700 | 1 | |a Spanoudakis, Emmanouil |e verfasserin |4 aut | |
| 700 | 1 | |a Frølund, Ulf |e verfasserin |4 aut | |
| 700 | 1 | |a Belotti, Angelo |e verfasserin |4 aut | |
| 700 | 1 | |a Oriol, Albert |e verfasserin |4 aut | |
| 700 | 1 | |a Moreau, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a McFadden, Ian |e verfasserin |4 aut | |
| 700 | 1 | |a Xia, Qing |e verfasserin |4 aut | |
| 700 | 1 | |a Arora, Mukta |e verfasserin |4 aut | |
| 700 | 1 | |a Dimopoulos, Meletios Athanasios |e verfasserin |4 aut | |
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