Last updated 16 days ago
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
810 patients around the world
Available in United States, Brazil, Spain
Overall rationale of the study is that combination treatments of talquetamab,
daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in
treatment of relapsed or refractory multiple myeloma through multiple mechanisms of
action. The study is divided into 3 phases: screening, treatment (until confirmed
progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the
study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of
consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy,
safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology
Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE
monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at
specified time points. Total duration of study will be up to 6 years 6 months.
Janssen Research & Development, LLC
17Research sites
810Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratioReceived at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposedDocumented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimenHave an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipientsDisease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drugKnown active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are requiredPlasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
Sites
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Recruiting
Instituto de Educação, Pesquisa e Gestão em Saúde
Recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Recruiting
Clinica São Germano
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Recruiting
Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
Recruiting
CEPEN - CENTRO DE PESQUISA E ENSINO DE SANTA CATARINA
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
StudyMonumenTAL-3
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05455320
