Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma
- Conditions
- Refractory Multiple Myeloma
- Interventions
- Registration Number
- NCT03731832
- Lead Sponsor
- GWT-TUD GmbH
- 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 ≥ 25% (absolute increase in serum must be ≥ 5 g/L) and/or urine M-protein (absolute increase in urine must be ≥ 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PICd MLN9708 Treatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide. PICd Pomalidomide 4 MG Oral Capsule Treatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide. PId Pomalidomide 4 MG Oral Capsule Treatment of eligible patients with combination of Pomalidomide, Ixazomib, Dexamethasone for all patients until disease progression. PId MLN9708 Treatment of eligible patients with combination of Pomalidomide, Ixazomib, Dexamethasone for all patients until disease progression. PId Dexamethasone Treatment of eligible patients with combination of Pomalidomide, Ixazomib, Dexamethasone for all patients until disease progression. PICd Dexamethasone Treatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide. PICd Cyclophosphamide Treatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide.
- Primary Outcome Measures
Name Time Method Overall Response rate (PId) according to the IMWG criteria. 1 year throughout study completion Overall response rate at PId
- Secondary Outcome Measures
Name Time Method Disease control rate 1 year throughout study completion Disease control rate in patients receiving PId (at least SD)
Disease control rate in patients intensified with PICd (at least SD) 1 year throughout study completion Disease control rate in patients intensified with PICd (at least SD)
Progression-free survival (PFS) 1 year throughout study completion Progression-free survival (PFS) for patients receiving PId and for patients receiving PICd
Overall response rate 1 year throughout study completion Overall response rate (PR or better) for patients intensified with PICd
Overall survival (OS) 1 year throughout study completion Overall survival (OS)
Subsequent anti-myeloma regimens (including best response) 1 year throughout study completion Best response during induction by PId
Trial Locations
- Locations (11)
Kliniken Ostalb Stauferklinikum Schwäbisch Gmünd
🇩🇪Mutlangen, Germany
phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Sozialstiftung Bamberg / Klinik am Bruderwald, Zentrum für Innere Medizin, Med. Klinik V, Hämatologie und internistische Onkologie
🇩🇪Bamberg, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
🇩🇪Frankfurt am main, Germany
Universitätsklinikum Magdeburg A.Ö.R / Klinik für Hämatologie und Onkologie
🇩🇪Magdeburg, Germany
Universitätsklinikum Jena / Klinik für Innere Medizin II, Abteilung für Hämatologie und internistische Onkologie
🇩🇪Jena, Germany
Universitätsklinikum Münster / Medizinische Klinik A
🇩🇪Münster, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Universitätsklinikum Ulm / Klinik für Innere Medizin III
🇩🇪Ulm, Germany
Studienzentrum Onkologie Ravensburg
🇩🇪Ravensburg, Germany
Klinikum rechts der Isar der TU München / III. Med. Klinik und Poliklinik
🇩🇪Munich, Bayern, Germany