{"entity":{"id":"monumental-1","kind":"trial","name":"MonumenTAL-1","aka":[],"tldr":"Showed that a second target, GPRC5D, works in myeloma, including after BCMA therapies have failed.","summary":"MonumenTAL-1, trial NCT04634552 sponsored by Janssen and reported in 2022, showed that a second target, GPRC5D, works in myeloma, including after BCMA-directed therapies have failed. In 288 patients after at least three prior lines the bispecific talquetamab produced responses in about 74 percent at weekly dosing and 72 percent at fortnightly dosing, and in 65 percent of those who had received prior T-cell redirection, while taste, skin and nail toxicities were frequent. OnCo links it to multiple myeloma, talquetamab, Ajai Chari and the pairing of BCMA-directed therapy followed by GPRC5D-directed therapy. Whether the distinctive toxicities can be managed for long-term use is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04634552","url":"https://clinicaltrials.gov/study/NCT04634552"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["talquetamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ajai-chari"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04634552","phase":"1/2","setting":"Relapsed/refractory myeloma after ≥3 lines: talquetamab (weekly or biweekly)","sponsor":"Janssen","result":"ORR ~73%.","started":"2021-02-01","startedType":"actual","yearReported":2022,"enrolled":288,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Talquetamab 0.8 mg/kg Q2W","n":145,"value":71.7},{"name":"Talquetamab 0.4 mg/kg QW","n":143,"value":74.1}],"source":"https://doi.org/10.1056/NEJMoa2204591"}]},"route":"/trials/monumental-1/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"drug":[{"id":"talquetamab","kind":"drug","name":"Talquetamab","route":"/drugs/talquetamab/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"person":[{"id":"ajai-chari","kind":"person","name":"Ajai Chari","route":"/people/ajai-chari/"}],"pairing":[{"id":"bcma-then-gprc5d","kind":"pairing","name":"BCMA-directed therapy → GPRC5D-directed therapy","route":"/pairings/bcma-then-gprc5d/"}],"paper":[{"id":"paper-monumental-1-talquetamab-nejm-2022","kind":"paper","name":"MonumenTAL-1: talquetamab, a GPRC5D-directed bispecific antibody for relapsed multiple myeloma","route":"/key-papers/paper-monumental-1-talquetamab-nejm-2022/"}]}}