Last updated 39 days ago
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
40 patients around the world
Available in Brazil
Janssen Research & Development, LLC
2Research sites
40Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- Participants with documented new diagnosis of multiple myeloma (MM) according to international myeloma working group (IMWG) diagnostic criteria.Participants must have standard-risk MM (stage I and II) based on revised International Staging System (R-ISS).Participants must be considered fit (score equals to [=] 0) or intermediate-fit (score=1) according to IMWG Frailty Index assessment (based on the Charlson Comorbidity Index, the Katz Activity of Daily Living and the Lawson Instrumental Activities of Daily Living).Measurable disease defined as: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >= 200 milligrams per 24 hours (mg/24 hours); Light chain MM without measurable disease in the serum or the urine: Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa lambda free light chain ratio.Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.
- Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM). Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy.Peripheral neuropathy or neuropathic pain of Grade >= 2, as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Known active or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.Stroke or seizure within 6 months of signing the informed consent form (ICF).Plasma cell leukemia at the time of screening (>= 5 percent [%] circulating plasma cells in peripheral blood smears), Waldenstrom macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes(POEMS) syndrome, or primary amyloid light chain amyloidosis with associated organ dysfunction.Presence of high-risk disease features: (a) Cytogenetic high risk lesions by MM fluorescence in situ hybridization (FISH) including deletion 17p (del[17p])/; (b) Presence of 1 or more extramedullary plasmacytomas.Seropositive for human immunodeficiency virus (HIV).
Sites
AC Camargo Cancer Center
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Recruiting
StudyaMMbition
SponsorJanssen Research & Development, LLC
Conditions
Multiple myeloma
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06577025
