Spots Global Cancer Trial Database for Ixazomib in Combination With Thalidomide - Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
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Trial Identification
Brief Title: Ixazomib in Combination With Thalidomide - Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Official Title: Ixazomib in Combination With Thalidomide - Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Study ID: NCT02410694
Conditions
Study Description
Brief Summary: Overview of Study Design: This is an open phase II, single-arm, multi-center study to evaluate progression free survival in patients receiving ixazomib in combination with thalidomide and dexamethasone (ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months. The patient population will consist of adult male and female patients with multiple myeloma (MM) with relapsed and/or refractory disease after at least one prior treatment line. In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide 100mg at days 1 to 28 (50mg in patients aged â„75 years), and dexamethasone 40mg (20mg in patients aged â„75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number of cycles is 8. Treatment will be discontinued in case of progressive disease or in case of no response after 4 cycles (†SD after 4 cycles). After discontinuation of therapy an end of treatment visit (EOT) will be performed within 14 days after the last dose of the last combination treatment cycle. After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients aged â„ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be administered to patients with â„ MR for a maximum period of 12 months. Patients who completed less than 8 cycles of ITD treatment do not qualify for maintenance phase. Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib maintenance therapy has concluded or discontinued the maintenance phase. A safety analysis will be conducted after enrollment of the first 6 patients and completion of at least two cycles in every patient.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ordensklinikum, KH der Barmherzigen Schwestern Linz, Interne I: Internistische Onkologie, HÀmatologie und Gastroenterologie, Linz, Oberösterreich, Austria
KH der Elisabethinen Linz, 1. Interne Abteilung, Linz, Oberösterreich, Austria
Klinikum Wels-Grieskirchen, IV. Interne Abteilung, Wels, Oberösterreich, Austria
Medizinische UniversitĂ€tsklinik Graz, Klinische Abteilung fĂŒr HĂ€matologie, Graz, Steiermark, Austria
UK Innsbruck, UniversitĂ€tsklinik fĂŒr Innere Medizin, Klinische Abteilung fĂŒr HĂ€matologie und Onkologie, Innsbruck, Tirol, Austria
A.ö. BK Kufstein, Abteilung fĂŒr Innere Medizin, Kufstein, Tirol, Austria
LKH Feldkirch, Interne E, Feldkirch, Vorarlberg, Austria
Kepler UniversitĂ€tsklinikum Linz, Innere Medizin 3, Zentrum fĂŒr HĂ€matologie und medizinische Onkologie, Linz, , Austria
UniversitĂ€tsklinik der PMU UniversitĂ€tsklinik fĂŒr Innere Medizin III, Salzburg, , Austria
Wilhelminenspital, Vienna, , Austria
KH der Barmherzigen BrĂŒder Wien, Innere Medizin, Wien, , Austria
Med. UniversitÀt Wien, UniversitÀtsklinik f. Innere Medizin I, Klin. Abt. f. HÀmatologie u. HÀmostaseologie, Wien, , Austria
Faculty Hospital Brno and Faculty of Medicine MU Brno 2nd Internal Clinic, Brno, , Czechia
FakultnĂ nemocnice Ostrava, Ostrava-Poruba, , Czechia
UniversitĂ€tsklinikum Leipzig - AöR SelbststĂ€ndige Abteilung fĂŒr HĂ€matologie, Internistische Onkologie und HĂ€mostaseologie, Leipzig, , Germany
UniversitĂ€tsklinikum TĂŒbingen, Innere Medizin II, Tubingen, , Germany
UniversitĂ€tsklinikum WĂŒrzburg, Medizinische Klinik und Poliklinik II Zentrum Innere Medizin, Wurzburg, , Germany
Contact Details
Name: Heinz Ludwig, MD
Affiliation: Wilhelminenspital Vienna
Role: STUDY_DIRECTOR
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