{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T02:11:46Z","timestamp":1790820706106,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,3,13]],"date-time":"2020-03-13T00:00:00Z","timestamp":1584057600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Multiple myeloma is an incurable progressive neoplastic disease that accounts for 10% of all hematologic malignancies. Even though significant progress has been made in the treatment of newly diagnosed multiple myeloma, the disease follows a relapsing course in the majority of patients, and there is a need for more effective therapeutic options for the treatment of relapsed or refractory multiple myeloma. CC\u20104047\u2010MM\u2010005 and CC\u20104047\u2010MM\u2010007 were phase 1 and 3 studies to evaluate the novel combination of pomalidomide, bortezomib, and low\u2010dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have already received lenalidomide\u2010based treatments early. This analysis was performed to characterize the population pharmacokinetics (PK) of pomalidomide from the combination treatment and to examine exposure\u2010response relationships. Our analysis showed that pomalidomide concentration\u2010time profiles from the combination treatment were adequately described with a 1\u2010compartment PK model, with first\u2010order absorption and elimination and pomalidomide exhibiting linear and time\u2010invariant PK with moderate variability from the combination treatment. Except for the body surface area, none of the tested covariates had an effect on pomalidomide PK. Although body surface area was identified as a statistically significant covariate of pomalidomide PK, the impact was not deemed clinically relevant. A flat exposure\u2010response curve was observed, consistent with a near\u2010saturated drug effect at the tested exposure range suggesting an appropriately recommended clinical dose of 4\u00a0mg of pomalidomide for the combination treatment. Finally, pomalidomide exposure was not associated with higher probabilities of dose interruption during cycle 1 or dose reduction during the treatment period.<\/jats:p>","DOI":"10.1002\/jcph.1602","type":"journal-article","created":{"date-parts":[[2020,3,13]],"date-time":"2020-03-13T17:04:31Z","timestamp":1584119071000},"page":"1061-1075","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Population Pharmacokinetics and Exposure Response Analysis of Pomalidomide in Subjects With Relapsed or Refractory Multiple Myeloma From the Novel Combination Treatment of Pomalidomide, Bortezomib, and Low\u2010Dose Dexamethasone"],"prefix":"10.1002","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7609-2683","authenticated-orcid":false,"given":"Yan","family":"Li","sequence":"first","affiliation":[{"name":"Translational Development and Clinical Pharmacology Celgene Corporation  Summit New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nastya","family":"Kassir","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting  Montreal Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaomin","family":"Wang","sequence":"additional","affiliation":[{"name":"Non\u2010Clinical Development Celgene Corporation  Summit New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Palmisano","sequence":"additional","affiliation":[{"name":"Translational Development and Clinical Pharmacology Celgene Corporation  Summit New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Zhou","sequence":"additional","affiliation":[{"name":"Translational Development and Clinical Pharmacology Celgene Corporation  Summit New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,3,13]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.20073"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.03.0551"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.leu.2403287"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa022340"},{"key":"e_1_2_8_6_1","unstructured":"Network NCC. 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