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Randomized phase III study (ADMYRE) of plitidepsin in combination with dexamethasone vs. dexamethasone alone in patients with relapsed/refractory multiple myeloma
I. Spicka, EM. Ocio, HE. Oakervee, R. Greil, RH. Banh, SY. Huang, JM. D'Rozario, MA. Dimopoulos, S. Martínez, S. Extremera, C. Kahatt, V. Alfaro, AM. Carella, N. Meuleman, R. Hájek, A. Symeonidis, CK. Min, P. Cannell, H. Ludwig, P. Sonneveld, MV. Mateos,
Language English Country Germany
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
ProQuest Central
from 1997-03-01
Medline Complete (EBSCOhost)
from 2000-01-01 to 1 year ago
Nursing & Allied Health Database (ProQuest)
from 1997-03-01
Health & Medicine (ProQuest)
from 1997-03-01
Springer Nature OA/Free Journals
from 1955-03-01
- MeSH
- Bortezomib administration & dosage MeSH
- Depsipeptides administration & dosage MeSH
- Dexamethasone administration & dosage MeSH
- Adult MeSH
- Lenalidomide administration & dosage MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate MeSH
- Multiple Myeloma drug therapy mortality MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols administration & dosage MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Thalidomide administration & dosage MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
The randomized phase III ADMYRE trial evaluated plitidepsin plus dexamethasone (DXM) versus DXM alone in patients with relapsed/refractory multiple myeloma after at least three but not more than six prior regimens, including at least bortezomib and lenalidomide or thalidomide. Patients were randomly assigned (2:1) to receive plitidepsin 5 mg/m2 on D1 and D15 plus DXM 40 mg on D1, D8, D15, and D22 (arm A, n = 171) or DXM 40 mg on D1, D8, D15, and D22 (arm B, n = 84) q4wk. The primary endpoint was progression-free survival (PFS). Median PFS without disease progression (PD) confirmation (IRC assessment) was 2.6 months (arm A) and 1.7 months (arm B) (HR = 0.650; p = 0.0054). Median PFS with PD confirmation (investigator's assessment) was 3.8 months (arm A) and 1.9 months (arm B) (HR = 0.611; p = 0.0040). Median overall survival (OS, intention-to-treat analysis) was 11.6 months (arm A) and 8.9 months (arm B) (HR = 0.797; p = 0.1261). OS improvement favoring arm A was found when discounting a crossover effect (37 patients crossed over from arm B to arm A) (two-stage method; HR = 0.622; p = 0.0015). The most common grade 3/4 treatment-related adverse events (% of patients arm A/arm B) were fatigue (10.8%/1.2%), myalgia (5.4%/0%), and nausea (3.6%/1.2%), being usually transient and reversible. The safety profile does not overlap with the toxicity observed with other agents used in multiple myeloma. In conclusion, efficacy data, the reassuring safety profile, and the novel mechanism of action of plitidepsin suggest that this combination can be an alternative option in patients with relapsed/refractory multiple myeloma after at least three prior therapy lines.
Clinical R and D Pharma Mar Colmenar Viejo Madrid Spain
Department of Clinical Haematology Mater Health Services Brisbane Australia
Department of Clinical Therapeutics Alexandra General Hospital Athens Greece
Department of Haemato Oncology St Bartholomew's Cancer Centre Barts Health NHS Trust London UK
Department of Hematology Canberra Hospital and Health Service Canberra Australia
Department of Hematology Erasmus MC Cancer Institute Rotterdam The Netherlands
Department of Hematology Institut Jules Bordet Brussels Belgium
Department of Medicine National Taiwan University Hospital Taipei Taiwan
References provided by Crossref.org
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- $a Spicka, Ivan $u Department of Medicine, Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic.
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- $a The randomized phase III ADMYRE trial evaluated plitidepsin plus dexamethasone (DXM) versus DXM alone in patients with relapsed/refractory multiple myeloma after at least three but not more than six prior regimens, including at least bortezomib and lenalidomide or thalidomide. Patients were randomly assigned (2:1) to receive plitidepsin 5 mg/m2 on D1 and D15 plus DXM 40 mg on D1, D8, D15, and D22 (arm A, n = 171) or DXM 40 mg on D1, D8, D15, and D22 (arm B, n = 84) q4wk. The primary endpoint was progression-free survival (PFS). Median PFS without disease progression (PD) confirmation (IRC assessment) was 2.6 months (arm A) and 1.7 months (arm B) (HR = 0.650; p = 0.0054). Median PFS with PD confirmation (investigator's assessment) was 3.8 months (arm A) and 1.9 months (arm B) (HR = 0.611; p = 0.0040). Median overall survival (OS, intention-to-treat analysis) was 11.6 months (arm A) and 8.9 months (arm B) (HR = 0.797; p = 0.1261). OS improvement favoring arm A was found when discounting a crossover effect (37 patients crossed over from arm B to arm A) (two-stage method; HR = 0.622; p = 0.0015). The most common grade 3/4 treatment-related adverse events (% of patients arm A/arm B) were fatigue (10.8%/1.2%), myalgia (5.4%/0%), and nausea (3.6%/1.2%), being usually transient and reversible. The safety profile does not overlap with the toxicity observed with other agents used in multiple myeloma. In conclusion, efficacy data, the reassuring safety profile, and the novel mechanism of action of plitidepsin suggest that this combination can be an alternative option in patients with relapsed/refractory multiple myeloma after at least three prior therapy lines.
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