Studieninformationen
Kurztitel:
TRIMM-2, 64407564MMY1002
Beschreibung:
A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with
Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple
Myeloma
Studiendesign:
Phase I/IB, , Monozentrisch, National
Therapielinien:
Alter:
>= 18 Jahre
Erkrankungen:
Ein-/Ausschlusskriterien:
Inclusion Criteria: Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level >= 1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200 milligram (mg)/24 hours; or Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose Women of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug Exclusion Criteria: Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless approved by sponsor Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
Universitätsklinikum Würzburg
97080 Würzburg
Medizinische Klinik II, Schwerpunkt Hämatologie/Onkologie
Rekrutierung läuft
Herr Prof. Dr. Martin Kortüm
Kortuem_M@ukw.de
Herr Dr. med. Xiang Zhou
zhou_x@ukw.de