{"doi":"10.1002/ajh.26361","title":"A phase I/<scp>II</scp> study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance <scp>A061202</scp>)","abstract":"Preclinical studies have demonstrated activity of the oral proteasome inhibitor (PI) ixazomib (IXA) in bortezomib-resistant multiple myeloma (MM) and synergy with immunomodulatory drugs. We therefore conducted a phase I/II study to establish the safety and preliminary efficacy of IXA with pomalidomide (POM) and dexamethasone (DEX) in lenalidomide (LEN)/PI-refractory MM. Dose escalation established a 4 mg dose of POM and IXA and 20/40 mg dose of DEX as the maximum tolerated dose. The phase II portion of the trial was redesigned and started anew after six patients had been randomized to IXA-POM-DEX due to a rapidly changing treatment landscape. Among the 29 evaluable LEN/PI-refractory patients treated with IXA-POM-DEX in phase I/II, the overall response rate (partial response or better) was 51.7% with a median duration of response of 16.8 months (range 56 days to 4.1 years), median progression-free survival of 4.4 months (95% confidence interval [CI]: 3.0-18.4), and median overall survival of 34.3 months (95% CI: 19.2 to not reached). Hematologic, gastrointestinal, and constitutional adverse events were common and consistent with the side-effect profiles of the individual agents. Our results support further evaluation of this all-oral regimen in relapsed/refractory MM.","journal":"American Journal of Hematology","year":2021,"id":174795,"datarank":0.9940454780039725,"base_score":3.1780538303479458,"endowment":3.1780538303479458,"self_citation_contribution":0.47670807455219194,"citation_network_contribution":0.5173374034517805,"self_endowment_contribution":0.47670807455219194,"citer_contribution":0.5173374034517805,"corpus_percentile":null,"corpus_rank":null,"citation_count":23,"citer_count":22,"citers_with_citation_signal":19,"citers_with_endowment":19,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9545,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02004275"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":400209,"name":"Vera J. Suman","orcid":"0000-0002-9640-5189","position":1,"is_corresponding":false},{"id":382455,"name":"Sascha A. Tuchman","orcid":"0000-0003-2109-1573","position":2,"is_corresponding":false},{"id":250468,"name":"Jacob P. Laubach","orcid":"0000-0001-7565-2052","position":3,"is_corresponding":false},{"id":298170,"name":"Hani Hassoun","orcid":"0000-0002-2036-1749","position":4,"is_corresponding":false},{"id":550340,"name":"Yvonne A. Efebera","orcid":"0000-0002-4163-8823","position":5,"is_corresponding":false},{"id":279185,"name":"Flora Mulkey","orcid":"0000-0003-0760-2648","position":6,"is_corresponding":false},{"id":714937,"name":"Misty Bova‐Solem","orcid":null,"position":7,"is_corresponding":false},{"id":526355,"name":"Katelyn Santo","orcid":null,"position":8,"is_corresponding":false},{"id":714938,"name":"Destin Carlisle","orcid":null,"position":9,"is_corresponding":false},{"id":406219,"name":"Philip L. McCarthy","orcid":"0000-0002-9577-3879","position":10,"is_corresponding":false},{"id":250469,"name":"Paul G. Richardson","orcid":"0000-0002-7426-8865","position":11,"is_corresponding":false},{"id":268268,"name":"Peter M. Voorhees","orcid":"0000-0003-1661-718X","position":0,"is_corresponding":true}],"reference_count":26,"raw_metadata":null,"created_at":"2026-07-18T23:47:06.584146Z","pmid":"34559902","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}