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All-oral ixazomib, ...
All-oral ixazomib, cyclophosphamide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma
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- Dimopoulos, Meletios A. (författare)
- National and Kapodistrian University of Athens
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- Grosicki, Sebastian (författare)
- Medical University of Silesia
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- Jędrzejczak, Wiesław W. (författare)
- Medical University of Warsaw
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- Nahi, Hareth (författare)
- Karolinska Institutet
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- Gruber, Astrid (författare)
- Karolinska University Hospital
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- Hansson, Markus (författare)
- Lund University,Lunds universitet,Myelomgruppen,Forskargrupper vid Lunds universitet,WCMM- Wallenberg center för molekylär medicinsk forskning,Medicinska fakulteten,Myeloma research group,Lund University Research Groups,WCMM-Wallenberg Centre for Molecular Medicine,Faculty of Medicine,Skåne University Hospital
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- Gupta, Neeraj (författare)
- Takeda Oncology Inc.
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- Byrne, Catriona (författare)
- Takeda Oncology Inc.
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- Labotka, Richard (författare)
- Takeda Oncology Inc.
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- Teng, Zhaoyang (författare)
- Takeda Oncology Inc.
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- Yang, Huyuan (författare)
- Takeda Oncology Inc.
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- Grzasko, Norbert (författare)
- St. John of Dukla Cancer Center in Lublin,Medical University of Lublin
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- Kumar, Shaji (författare)
- Mayo Clinic Minnesota
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(creator_code:org_t)
- Elsevier BV, 2019
- 2019
- Engelska 10 s.
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Ingår i: European Journal of Cancer. - : Elsevier BV. - 0959-8049 .- 1879-0852. ; 106, s. 89-98
- Relaterad länk:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
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- Background: Novel efficacious treatments with long-term tolerability are needed for transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. This phase 2 study evaluated the safety and efficacy of all-oral ixazomib-cyclophosphamide-dexamethasone (ICd) followed by single-agent ixazomib maintenance. Patients and methods: Patients were randomised (1:1) to receive 4.0 mg of ixazomib, 300 (Arm A) or 400 (Arm B) mg/m2 of cyclophosphamide (days 1, 8, and 15), and 40 mg of dexamethasone (days 1, 8, 15, and 22) as induction (up to 13 × 28-day cycles), followed by single-agent ixazomib maintenance (28-day cycles) until progressive disease, death, or unacceptable toxicity. Primary end-point was complete response (CR) + very good partial response (VGPR) rate for ICd induction. Results: Seventy patients were enrolled (n = 36 Arm A; n = 34 Arm B); median age was 73 years (range, 61–87). At data cut-off, 66% of patients had completed 13 induction cycles followed by ixazomib maintenance. Median overall treatment duration was 19 cycles (range, 1–29); 21% of patients discontinued treatment during induction and 3% during maintenance due to adverse events (AEs). During induction, among 67 response-evaluable patients, CR+VGPR rate was 25%, and overall response rate (ORR) was 73%. Including the maintenance phase, CR+VGPR rate was 33%, and ORR was 76%. Median progression-free survival was 23.5 months (median follow-up: 26.1 months). The most common all-grade AE was neutropenia (31%). Grade ≥3 AEs were reported by 73% of patients. Five on-study deaths occurred (not treatment-related). Conclusions: ICd treatment followed by ixazomib maintenance is tolerable and active in elderly, transplant-ineligible NDMM patients. Trial registration number: NCT02046070.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- Elderly
- Multiple myeloma
- Newly diagnosed
- Oral therapy
- Transplant-ineligible
Publikations- och innehållstyp
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- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Dimopoulos, Mele ...
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Grosicki, Sebast ...
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Jędrzejczak, Wie ...
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Nahi, Hareth
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Gruber, Astrid
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Hansson, Markus
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Gupta, Neeraj
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Byrne, Catriona
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Labotka, Richard
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Teng, Zhaoyang
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Yang, Huyuan
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Grzasko, Norbert
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Kumar, Shaji
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- MEDICIN OCH HÄLSOVETENSKAP
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och Klinisk medicin
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och Cancer och onkol ...
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European Journal ...
- Av lärosätet
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Lunds universitet
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Karolinska Institutet