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Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma.

Publication ,  Journal Article
Shah, JJ; Stadtmauer, EA; Abonour, R; Cohen, AD; Bensinger, WI; Gasparetto, C; Kaufman, JL; Lentzsch, S; Vogl, DT; Gomes, CL; Pascucci, N ...
Published in: Blood
November 12, 2015

Treatment options for patients with heavily pretreated relapsed and/or refractory multiple myeloma remain limited. We evaluated a novel therapeutic regimen consisting of carfilzomib, pomalidomide, and dexamethasone (CPD) in an open-label, multicenter, phase 1, dose-escalation study. Patients who relapsed after prior therapy or were refractory to the most recently received therapy were eligible. All patients were refractory to prior lenalidomide. Patients received carfilzomib IV on days 1, 2, 8, 9, 15, and 16 (starting dose of 20/27 mg/m(2)), pomalidomide once daily on days 1 to 21 (4 mg as the initial dose level), and dexamethasone (40 mg oral or IV) on days 1, 8, 15, and 22 of 28-day cycles. The primary objective was to evaluate the safety and determine the maximum tolerated dose (MTD) of the regimen. A total of 32 patients were enrolled. The MTD of the regimen was dose level 1 (carfilzomib 20/27 mg/m(2), pomalidomide 4 mg, dexamethasone 40 mg). Hematologic adverse events (AEs) occurred in ≥60% of all patients, including 11 patients with grade ≥3 anemia. Dyspnea was limited to grade 1/2 in 10 patients. Peripheral neuropathy was uncommon and limited to grade 1/2. Eight patients had dose reductions during therapy, and 7 patients discontinued treatment due to AEs. Two deaths were noted on study due to pneumonia and pulmonary embolism (n = 1 each). The combination of CPD is well-tolerated and highly active in patients with relapsed/refractory multiple myeloma. This trial was registered at www.clinicaltrials.gov as #NCT01464034.

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Published In

Blood

DOI

EISSN

1528-0020

Publication Date

November 12, 2015

Volume

126

Issue

20

Start / End Page

2284 / 2290

Location

United States

Related Subject Headings

  • Time Factors
  • Thalidomide
  • Recurrence
  • Pulmonary Embolism
  • Pneumonia
  • Oligopeptides
  • Multiple Myeloma
  • Middle Aged
  • Maximum Tolerated Dose
  • Male
 

Citation

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Chicago
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MLA
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Shah, J. J., Stadtmauer, E. A., Abonour, R., Cohen, A. D., Bensinger, W. I., Gasparetto, C., … Durie, B. G. M. (2015). Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma. Blood, 126(20), 2284–2290. https://doi.org/10.1182/blood-2015-05-643320
Shah, Jatin J., Edward A. Stadtmauer, Rafat Abonour, Adam D. Cohen, William I. Bensinger, Cristina Gasparetto, Jonathan L. Kaufman, et al. “Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma.Blood 126, no. 20 (November 12, 2015): 2284–90. https://doi.org/10.1182/blood-2015-05-643320.
Shah JJ, Stadtmauer EA, Abonour R, Cohen AD, Bensinger WI, Gasparetto C, et al. Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma. Blood. 2015 Nov 12;126(20):2284–90.
Shah, Jatin J., et al. “Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma.Blood, vol. 126, no. 20, Nov. 2015, pp. 2284–90. Pubmed, doi:10.1182/blood-2015-05-643320.
Shah JJ, Stadtmauer EA, Abonour R, Cohen AD, Bensinger WI, Gasparetto C, Kaufman JL, Lentzsch S, Vogl DT, Gomes CL, Pascucci N, Smith DD, Orlowski RZ, Durie BGM. Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma. Blood. 2015 Nov 12;126(20):2284–2290.

Published In

Blood

DOI

EISSN

1528-0020

Publication Date

November 12, 2015

Volume

126

Issue

20

Start / End Page

2284 / 2290

Location

United States

Related Subject Headings

  • Time Factors
  • Thalidomide
  • Recurrence
  • Pulmonary Embolism
  • Pneumonia
  • Oligopeptides
  • Multiple Myeloma
  • Middle Aged
  • Maximum Tolerated Dose
  • Male