Session: 653. Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Poster III
Hematology Disease Topics & Pathways:
Research, Plasma Cell Disorders, Clinical Research, Combination therapy, Diseases, Therapies, Lymphoid Malignancies
Study Design and Methods: Eligible patients will be aged ≥18 years with NDMM and are either ineligible or not intended for ASCT as initial therapy, have measurable disease, and an ECOG performance status score 0–2. A safety run-in phase for Tec-DR will precede the randomized phase. Approximately 1000 patients will be randomized 1:1 to receive Tec-DR or DRd. Treatment will continue until progressive disease, death, intolerable toxicity, loss to follow-up, withdrawal of consent, or end of study, whichever occurs first. The dual primary endpoints are PFS and minimal residual disease (MRD)-negative complete response (CR) sustained for at least 12 months. Secondary endpoints include rate of CR or better, overall survival, rate of MRD-negative CR, rate of very good partial response or better, PFS2, patient-reported outcomes, and adverse events (AEs). Response will be assessed using 2016 International Myeloma Working Group criteria. AEs will be graded by Common Terminology Criteria for AEs v5.0, except for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, which will be graded by American Society for Transplantation and Cellular Therapy guidelines. The study will open for enrollment in Q4 2022. Results from this trial will provide insights into a possible new treatment regimen (Tec-DR) for patients with NDMM, which may provide improved outcomes.
Disclosures: Krishnan: Amgen: Speakers Bureau; GlaxoSmithKline: Consultancy, Speakers Bureau; Bristol Myers Squibb: Consultancy, Other: Stock Ownership (not including stocks owned in a managed portfolio), Speakers Bureau; Sutro: Consultancy; Sanofi: Consultancy; Pfizer: Consultancy; Adaptive: Consultancy; Regeneron: Consultancy; Janssen: Consultancy, Research Funding; AstraZeneca: Consultancy; Artiva: Consultancy; BMS, Janssen, Adaptive, GSK, AbbVie, Regeneron, Sanofi, AstraZeneca: Consultancy; BMS: Current equity holder in publicly-traded company; Janssen: Research Funding; Takeda, GSK, BMS: Speakers Bureau; Sutro SAB: Speakers Bureau; Takeda: Speakers Bureau. Manier: Abbvie, Adaptive Biotechnology, Amgen, Celgene/BMS, GlaxoSmithKline, Janssen, Novartis, Oncopeptide, Regeneron, Roche, Sanofi, Takeda: Consultancy. Terpos: EUSA Pharma: Honoraria, Other: Travel expenses; BMS: Honoraria; Takeda: Honoraria, Other: Travel expenses, Research Funding; Amgen: Honoraria, Other: Travel expenses, Research Funding; GSK: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Novartis: Honoraria; Genesis: Honoraria, Research Funding; Sanofi: Honoraria, Research Funding. Usmani: AbbVie, Amgen, BMS, Celgene, EdoPharma, Genentech, Gilead, GSK, Janssen Pharmaceuticals, Oncopeptides, Sanofi, Seagen Inc., formerly Seattle Genetics, Inc., Secura Bio, Inc., SkylineDX, Takeda, TeneoBio , Amgen, Array Biopharma, BMS, Celgene, GSK, Janssen: Research Funding; Amgen, Array Biopharma, BMS, Celgene, GSK, Janssen Pharmaceuticals, Merck, Pharmacyclics, Sanofi, Seagen Inc., formerly Seattle Genetics, Inc., SkylineDX, Takeda: Consultancy; Amgen, BMS, Janssen Pharmaceuticals, Sanofi: Speakers Bureau. Khan: Janssen, Johnson & Johnson: Current Employment. Pearson: Janssen Research & Development, UK: Current Employment. Girgis: Janssen Research & Development, Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Guo: Janssen Research and Development ☒Current Employment: Current Employment. McAleer: Janssen: Current Employment; Passage Bio: Current equity holder in private company, Ended employment in the past 24 months. Olyslager: Janssen: Current Employment. Kampfenkel: Janssen: Current Employment. van de Donk: Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; Cellectis: Research Funding; Servier: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol Myers: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees.
OffLabel Disclosure: at the time of abstract submission, teclistamab is being investigated for the treatment of multiple myeloma but is not yet not approved
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