Spots Global Cancer Trial Database for Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma
Official Title: Pomalidomide, Ixazomib, and Dexamethasone (PId) With or Without Intensification by Cyclophosphamide (PICd): A Phase II Study in Relapsed or Refractory Multiple Myeloma
Study ID: NCT03731832
Conditions
Study Description
Brief Summary: The study is designed as a multicenter, non-randomized, Phase II trial with one treatment arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory multiple myeloma are planned to be included in the study. After the first 6 patients will have finished the first treatment cycle of the induction phase the DMC will assess safety and tolerability of the treatment schedule and decide about the further continuation of the study.
Detailed Description: The study is designed as an open-label, non-randomized, multicenter study to investigate the clinical activity of pomalidomide administered once daily in combination with oral ixazomib and dexamethasone (PId) until disease progression according to IMWG criteria. Patients with clinical relapse (any one of the following: deterioration of renal function, hypercalcemia, newly developing osteolytic lesions and/or soft tissue plasmacytomas) will go off study and receive further treatment according to their treating physician. Patients with isolated biochemical relapse with an increase of serum M-protein of â„ 25% (absolute increase in serum must be â„ 5 g/L) and/or urine M-protein (absolute increase in urine must be â„ 200 mg/24h) or in the difference between involved and uninvolved FLC levels (provided, the absolute increase is \> 100 mg/L) without further signs or symptoms will proceed to the intensification phase (PICd). The intensification phase (PICd) will last until further disease progression. In case of significant haematological and non-haematological toxicities, dose adjustments and/or interruption of the study drugs may be necessary. Response assessments will be performed every four weeks by evaluation of serum and 24 hour urine specimens. "Progressive disease" (PD) will require a consecutive confirmatory measurement.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinikum rechts der Isar der TU MĂŒnchen / III. Med. Klinik und Poliklinik, Munich, Bayern, Germany
phase drei HĂ€mato-Onkologischer Studienkreis am Klinikum Aschaffenburg, Aschaffenburg, , Germany
Sozialstiftung Bamberg / Klinik am Bruderwald, Zentrum fĂŒr Innere Medizin, Med. Klinik V, HĂ€matologie und internistische Onkologie, Bamberg, , Germany
Klinikum der Johann Wolfgang Goethe-UniversitÀt Frankfurt am Main, Frankfurt am main, , Germany
UniversitĂ€tsklinikum Jena / Klinik fĂŒr Innere Medizin II, Abteilung fĂŒr HĂ€matologie und internistische Onkologie, Jena, , Germany
UniversitĂ€tsklinikum Magdeburg A.Ă.R / Klinik fĂŒr HĂ€matologie und Onkologie, Magdeburg, , Germany
Kliniken Ostalb Stauferklinikum SchwĂ€bisch GmĂŒnd, Mutlangen, , Germany
UniversitĂ€tsklinikum MĂŒnster / Medizinische Klinik A, MĂŒnster, , Germany
Studienzentrum Onkologie Ravensburg, Ravensburg, , Germany
UniversitĂ€tsklinikum Ulm / Klinik fĂŒr Innere Medizin III, Ulm, , Germany
UniversitĂ€tsklinikum WĂŒrzburg, WĂŒrzburg, , Germany
Contact Details
Name: Stefan Knop, Prof.
Affiliation: UniversitĂ€tsklinikum WĂŒrzburg / Medizinische Klinik und Poliklinik II
Role: PRINCIPAL_INVESTIGATOR
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