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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

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 für Klinische Onkologie, Universitätsklinik für Innere Medizin I, Vienna, , Austria

Charité - 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 für Stammzell- und Immuntherapie, II. Medizinischen Klinik,, Kiel, , Germany

Klinikum rechts der Isar/ Studien / III. Med. Klinik, Munich, , Germany

Medizinische Klinik II, Abt. Hämatologie, Onkologie,, Tübingen, , Germany

Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Studienambulanz für Hämatologie/Onkologie und Infektiologie, Würzburg, , Germany

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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