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Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma.

Publication ,  Journal Article
Chari, A; Larson, S; Holkova, B; Cornell, RF; Gasparetto, C; Karanes, C; Matous, JV; Niesvizky, R; Valent, J; Lunning, M; Usmani, SZ; Chang, L ...
Published in: Leuk Lymphoma
November 2018

This phase 1, dose-finding study investigated ibrutinib and carfilzomib ± dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma (≥2 lines of therapy including bortezomib and an immunomodulatory agent). Of 43 patients enrolled, 74% were refractory to bortezomib and 23% had high-risk cytogenetics. No dose-limiting toxicities were observed. The recommended phase 2 dose was ibrutinib 840 mg and carfilzomib 36 mg/m2 with dexamethasone. The most common ≥ grade 3 (>10%) treatment-emergent adverse events were hypertension, anemia, pneumonia, fatigue, diarrhea, and thrombocytopenia. Overall response rate was 67% (very good partial response, 21%; stringent complete response, 2%), with an additional 9% minimal response. Median progression-free survival was 7.2 months and was not inferior in refractory nor high-risk patients. Median overall survival was not reached. Ibrutinib plus carfilzomib demonstrated encouraging responses with a manageable safety profile in this advanced population.

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Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

November 2018

Volume

59

Issue

11

Start / End Page

2588 / 2594

Location

United States

Related Subject Headings

  • Pyrimidines
  • Pyrazoles
  • Piperidines
  • Outcome Assessment, Health Care
  • Oligopeptides
  • Neoplasm Recurrence, Local
  • Multiple Myeloma
  • Middle Aged
  • Male
  • Immunology
 

Citation

APA
Chicago
ICMJE
MLA
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Chari, A., Larson, S., Holkova, B., Cornell, R. F., Gasparetto, C., Karanes, C., … Chhabra, S. (2018). Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma. Leuk Lymphoma, 59(11), 2588–2594. https://doi.org/10.1080/10428194.2018.1443337
Chari, Ajai, Sarah Larson, Beata Holkova, Robert F. Cornell, Cristina Gasparetto, Chatchada Karanes, Jeffrey V. Matous, et al. “Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma.Leuk Lymphoma 59, no. 11 (November 2018): 2588–94. https://doi.org/10.1080/10428194.2018.1443337.
Chari A, Larson S, Holkova B, Cornell RF, Gasparetto C, Karanes C, et al. Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma. Leuk Lymphoma. 2018 Nov;59(11):2588–94.
Chari, Ajai, et al. “Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma.Leuk Lymphoma, vol. 59, no. 11, Nov. 2018, pp. 2588–94. Pubmed, doi:10.1080/10428194.2018.1443337.
Chari A, Larson S, Holkova B, Cornell RF, Gasparetto C, Karanes C, Matous JV, Niesvizky R, Valent J, Lunning M, Usmani SZ, Anderson LD, Chang L, Lee Y, Pak Y, Salman Z, Graef T, Bilotti E, Chhabra S. Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma. Leuk Lymphoma. 2018 Nov;59(11):2588–2594.

Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

November 2018

Volume

59

Issue

11

Start / End Page

2588 / 2594

Location

United States

Related Subject Headings

  • Pyrimidines
  • Pyrazoles
  • Piperidines
  • Outcome Assessment, Health Care
  • Oligopeptides
  • Neoplasm Recurrence, Local
  • Multiple Myeloma
  • Middle Aged
  • Male
  • Immunology