Spots Global Cancer Trial Database for Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma
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Trial Identification
Brief Title: Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma
Official Title: An Open-label Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
Study ID: NCT02902965
Conditions
Study Description
Brief Summary: This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma.
Detailed Description: Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoeitic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with bortezomib and dexamethasone in subjects with relapsed/relapsed and refractory multiple myeloma.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fakultní nemocnice Brno, Brno, , Czechia
Fakultní nemocnice Hradec Králové, Nový Hradec Králové, , Czechia
Fakultní nemocnice Ostrava, Ostrava-Poruba, , Czechia
Všeobecná fakultní nemocnice v Praha, Praha 2, , Czechia
Helios-Kliniken Berlin-Buch, Berlin, , Germany
Vivantes Klinikum Spandau, Berlin, , Germany
Universitätsklinikum Jena, Jena, , Germany
Klinikum der Universität München Campus Grosshadern, München, , Germany
251 General Air Force Hospital, Athens, , Greece
General Hospital of Athens "Alexandra", Athens, , Greece
General Hospital of Athens "Evangelismos", Athens, , Greece
General Hospital of Athens "LAIKO", Athens, , Greece
University General Hospital of Patra, Patras, , Greece
General Hospital of Thessaloniki "G. Papanikolau", Thessaloniki, , Greece
IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori, Meldola (FC), , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
Ospedale degli Infermi, Rimini, , Italy
Azienda Ospedaliera S. Maria di Terni, Terni, , Italy
Hospital Universitario Rey Juan Carlos, Mostoles, Madrid, Spain
Complejo Hospitalario Universitario A Coruña, A Coruna, , Spain
ICO Badalona-Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Ankara University Medical Faculty, Ankara, , Turkey
Dokuz Eylul University Medicine Faculty, Izmir, , Turkey
Erciyes University Medical Faculty, Kayseri, , Turkey
Ondokuz Mayis Univ. Med. Fac., Samsun, , Turkey
Contact Details
Name: Bernhard Hauns, MD
Affiliation: Pharmacyclics Switzerland GmbH
Role: STUDY_DIRECTOR
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