Spots Global Cancer Trial Database for A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
Official Title: A Phase 1/2a, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD 38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
Study ID: NCT01421186
Conditions
Study Description
Brief Summary: This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.
Detailed Description: The study enrolled patients aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0¡01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w \[twice a week\] and q1w \[weekly\] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AKH (Allgemeines Krankenhaus der Stadt Wien), Abteilung fßr Klinische Onkologie, Universitätsklinik fßr Innere Medizin I, Vienna, , Austria
CharitÊ - Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin, CC 14: Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie, Berlin, , Germany
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Medizinische Klinik 5 - Hämatologie und Internist. Onkologie, Universitätsklinikum Erlangen, Erlangen, , Germany
Medizinische Universitätsklinik, Abt. Innere Medizin I, Freiburg, , Germany
Universitäsklinikum Heidelberg, Klin.-Pharmakologisches Studienzentrum, Heidelberg, , Germany
Sektion fĂźr Stammzell- und Immuntherapie, II. Medizinischen Klinik,, Kiel, , Germany
Klinikum rechts der Isar/ Studien / III. Med. Klinik, Munich, , Germany
Medizinische Klinik II, Abt. Hämatologie, Onkologie,, Tßbingen, , Germany
Universitätsklinikum Wßrzburg, Medizinische Klinik und Poliklinik II, Studienambulanz fßr Hämatologie/Onkologie und Infektiologie, Wßrzburg, , Germany
Contact Details
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