{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["101(12)"],"submitter":["Jing H"],"funding":["Janssen Research & Development, LLC"],"pubmed_abstract":["Daratumumab monotherapy demonstrated favorable safety and efficacy in relapsed/refractory multiple myeloma (RRMM) patients in the global phase 1/2 GEN501 and phase 2 SIRIUS studies. MMY1003 evaluated daratumumab monotherapy specifically in Chinese patients with RRMM. This 3-part, open-label, phase 1, dose-escalation study included patients with ≥ 2 prior lines of therapy. Part 3 included patients who had received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) and experienced disease progression on their last regimen. Patients received intravenous daratumumab 8 mg/kg or 16 mg/kg in part 1 and 16 mg/kg in parts 2 + 3. Primary endpoints were dose-limiting toxicity (DLT; part 1), pharmacokinetics (parts 1 + 2), and adverse events (AEs). Fifty patients enrolled. The first 3 patien"],"journal":["Annals of hematology"],"pagination":["2679-2690"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9646544"],"repository":["biostudies-literature"],"pubmed_title":["Safety and efficacy of daratumumab in Chinese patients with relapsed or refractory multiple myeloma: a phase 1, dose-escalation study (MMY1003)."],"pmcid":["PMC9646544"],"pubmed_authors":["Jing H","Li J","Qi M","Yang L","Qi J","Yang M","Fan N","Ji J","Qiu L","Li Y","Fu C","Lu J","Jin J"],"additional_accession":[]},"is_claimable":false,"name":"Safety and efficacy of daratumumab in Chinese patients with relapsed or refractory multiple myeloma: a phase 1, dose-escalation study (MMY1003).","description":"Daratumumab monotherapy demonstrated favorable safety and efficacy in relapsed/refractory multiple myeloma (RRMM) patients in the global phase 1/2 GEN501 and phase 2 SIRIUS studies. MMY1003 evaluated daratumumab monotherapy specifically in Chinese patients with RRMM. This 3-part, open-label, phase 1, dose-escalation study included patients with ≥ 2 prior lines of therapy. Part 3 included patients who had received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) and experienced disease progression on their last regimen. Patients received intravenous daratumumab 8 mg/kg or 16 mg/kg in part 1 and 16 mg/kg in parts 2 + 3. Primary endpoints were dose-limiting toxicity (DLT; part 1), pharmacokinetics (parts 1 + 2), and adverse events (AEs). Fifty patients enrolled. The first 3 patien","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Dec","modification":"2025-05-29T16:11:28.534Z","creation":"2025-04-06T01:50:53.667Z"},"accession":"S-EPMC9646544","cross_references":{"pubmed":["36301338"],"doi":["10.1007/s00277-022-04951-3"]}}