Studieninformationen
Kurztitel:
DREAMM 7 - 207503
Beschreibung:
DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma
Studiendesign:
Phase III, , Multizentrisch, International
Therapielinien:
Alter:
>= 18 Jahre
Erkrankungen:
Ein-/Ausschlusskriterien:
Inclusion Criteria: Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria. Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Must have at least 1 aspect of measurable disease, defined as one of the following; Urine M-protein excretion >=200 mg per 24-hour, or Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65). All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia. Adequate organ function Exclusion Criteria: Intolerant to daratumumab. Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment). Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy. Prior allogenic stem cell transplant. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. Corneal epithelial disease.
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
common:study_status_active
Universitätsklinikum Würzburg
97080 Würzburg
Medizinische Klinik II, Schwerpunkt Hämatologie/Onkologie
Herr Prof. Dr. Martin Kortüm
Kortuem_M@ukw.de
Herr Dr. med. Xiang Zhou
zhou_x@ukw.de