Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

September 20, 2018

Primary Completion Date

April 22, 2024

Study Completion Date

April 22, 2024

Conditions
Refractory Multiple Myeloma
Interventions
DRUG

MLN9708

Study drug will be given as a single, oral dose of 4.0 mg weekly (day 1, 8 and 15) for 3 weeks, followed by 1 week without study drug in a 28-day cycle

DRUG

Pomalidomide 4 MG Oral Capsule

Study drug will be given as an oral dose of 4.0 mg on day 1 until day 21, followed by 1 week without study drug in a 28-day cycle.

DRUG

Dexamethasone

Dexamethasone will be administered as a single, oral dose of 40 mg/day weekly on day 1, 8, 15 and 22 in patients from 18 to 74 years old. For patients ≥ 75 years old dose has to be reduced to 20 mg/day with the same treatment schedule.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered once daily as an oral dose of 50 mg on cycle days 1 to 21, followed by one week without drug in a 28-day cycle.

Trial Locations (11)

39120

Universitätsklinikum Magdeburg A.Ö.R / Klinik für Hämatologie und Onkologie, Magdeburg

48149

Universitätsklinikum Münster / Medizinische Klinik A, Münster

60590

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main

63739

phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg, Aschaffenburg

73557

Kliniken Ostalb Stauferklinikum Schwäbisch Gmünd, Mutlangen

81675

Klinikum rechts der Isar der TU München / III. Med. Klinik und Poliklinik, Munich

88212

Studienzentrum Onkologie Ravensburg, Ravensburg

89081

Universitätsklinikum Ulm / Klinik für Innere Medizin III, Ulm

96049

Sozialstiftung Bamberg / Klinik am Bruderwald, Zentrum für Innere Medizin, Med. Klinik V, Hämatologie und internistische Onkologie, Bamberg

97080

Universitätsklinikum Würzburg, Würzburg

07747

Universitätsklinikum Jena / Klinik für Innere Medizin II, Abteilung für Hämatologie und internistische Onkologie, Jena

All Listed Sponsors
lead

GWT-TUD GmbH

OTHER

NCT03731832 - Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter