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ACTIVE NOT RECRUITING
NCT03948035
PHASE3

Elotuzumab in Combination With Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) Versus KRd in MM

Sponsor: Wuerzburg University Hospital

View on ClinicalTrials.gov

Summary

Of the next-generation compounds, the monoclonal antibodies (moAbs) have recently attracted a lot of interest in MM. The anti-SLAMF7 directed moAb elotuzumab has completed phase III trials in MM patients. One phase III trial in MM patients with one to three prior lines of therapy compared elotuzumab-Rd with standard Rd. The triple combination was shown to significantly prolong PFS in this patient cohort with a greater proportion of patients in at least very good partial response (VGPR) when compared to subjects on Rd. Notably, the rate of infusion-related reactions with this specific moAb was very low, with an overall rate of 10% in premedicated patients and only 1% of Grade 3 severity. Grades 4/5 infusion-related reactions were absent and only 1% of patients on elotuzumab discontinued for infusion-related reactions. Of particular interest is the observation in this trial, that response and PFS were independent of cytogenetic high-risk features, i.e., deletion of chromosome 17p and translocation t(4;14). This effect distinguishes elotuzumab from most, if not all, other drug-based approaches. The investigators assume that incorporating the moAb into the KRd triple induction regimen should result in an even higher rate of deep (negative for MRD in conjunction with at least very good partial response \[VGPR\] as defined by the International Myeloma Working Group \[IMWG\]) with these responses occurring independently of cytogenetic risk. Due to potential interference of elotuzumab with serum immune fixation, the investigators chose VGPR rather than complete response (CR) to exclude false-positive immunofixation results. Furthermore the investigators hypothesize that combining elotuzumab with lenalidomide should prolong PFS further.

Official title: Elotuzumab in Combination With Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) Versus KRd Prior to and Following Auto-SCT in Newly Diagnosed Multipe Myeloma and Subsequent Maintenance With Elotuzumab and Lenalidomide Versus Single-Agent Lenalidomide- A Phase III Study by DSMM

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

576

Start Date

2018-08-28

Completion Date

2029-08

Last Updated

2023-05-06

Healthy Volunteers

No

Interventions

DRUG

Elotuzumab

i.v. infusion. Induction 6 cycles: 10mg/kg BW D1,8,15,22 of cycle 1 and 2, D1,15 of cycles 3-6. Consolidation 4 cycles: 10mg/kg BW D1,15 of cycle 1-4. Maintenance 28-day cycles: 20mg/kg BW D1 of each 28-day cycle.

DRUG

Carfilzomib

i.v. infusion. Induction 6 cycles: 20 mg/m² on D1 and 2 of cycle 1, 36 mg/m² on D8, 9, 15, 16 of cycle 1, 36 mg/m² on D1,2,8,9,15,16 of cycle 2-6; Consolidation 4 cycles: 36 mg/m² on days 1, 2, 8, 9, 15, 16 of cycles 1-4.

DRUG

Lenalidomide

hard capsule for oral use. Induction 6 cycles: 25mg D1-21 of cycle 1-6. Consolidation 4 cycles: 15mg D1-21 of cycle 1, 25mg D1-21 ov cycle 2-4. Maintenance 28-day cycles: 10mg D1-28 of cycle 1,2,3, 15mg D1-28 of cycle 4 and all subsequent cycles.

DRUG

Dexamethasone

orally and i.v. IN ARM A:Induction 6 cycles: 28mg p.o. and 8mg i.v. D1,8,15,22 of cycles 1-2 and D1,15 of cycles 3-6, 40mg p.o. D8,22 of cycle 3-6. Consolidation 4 cycles: 28mg p.o. and 8mg i.v. D1,15 of cycle 1-4 and 20mg p.o. D8,22 of cycle 1-4. IN ARM B: Induction 6 cycles: 40mg p.o. D1,8,15,22 of cycles 1-6. Consolidation 4 cycles: 20mg p.o. D1,8,15, 22 of cycle 1-4 .

OTHER

autologous stem cell transplant

autologous stem cell transplant

Locations (56)

Univ. Klinikum Krems

Krems, Lower Austria, Austria

Universitätklinikum St. Pölten

Sankt Pölten, Lower Austria, Austria

LKH-Universitätsklinikum Graz

Graz, Styria, Austria

Medizinische Universität Innsbruck

Innsbruck, Tyrol, Austria

Kepler Universitätsklinikum

Linz, Upper Austria, Austria

Klinikum Wels-Grieskirchen

Wels, Upper Austria, Austria

LKH Rankweil-Feldkirch

Rankweil, Vorarlberg, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

AKH Meduni Wien

Vienna, Austria

Klinik Ottakring

Vienna, Austria

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Kliniken Ostalb

Mutlangen, Baden-Wurttemberg, Germany

Studienzentrum Onkologie Ravensburg

Ravensburg, Baden-Wurttemberg, Germany

Diakonieklinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Robert-Bosch Krankenhaus

Stuttgart, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Onkologie Schwarzwald-Alb

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Gesundgheitszentrum St. Marien

Amberg, Bavaria, Germany

Klinikum Augsburg

Augsburg, Bavaria, Germany

Sozialstiftung Bamberg

Bamberg, Bavaria, Germany

Klinikum Bayreuth

Bayreuth, Bavaria, Germany

Klinikum Kempten-Oberallgäu

Kempten (Allgäu), Bavaria, Germany

Rotkreuzklinikum München

Munich, Bavaria, Germany

Ludwig-Maximilians-Universität München

Munich, Bavaria, Germany

Klinikum rechts der Isar der TU München

Munich, Bavaria, Germany

Klinikum Nürnberg Nord

Nuremberg, Bavaria, Germany

Uniklinikum Regensburg

Regensburg, Bavaria, Germany

Klinikum Traunstein

Traunstein, Bavaria, Germany

Universitätsklinikum Würzburg, Medizinische Klinik II

Würzburg, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Göttingen

Göttingen, Lower Saxony, Germany

Med. Hochschule Hannover

Hanover, Lower Saxony, Germany

Klinikum Oldenburg

Oldenburg, Lower Saxony, Germany

Universitätmedizin Greifswald

Greifswald, Mecklenburg-Pomerania, Germany

Universitätsmedizin Rostock

Rostock, Mecklenburg-Pomerania, Germany

Helios Kliniken

Schwerin, Mecklenburg-Pomerania, Germany

Evangelisches Klinikum Bethel

Bielefeld, North Rhine-Westphalia, Germany

St. Johannes Hospital

Dortmund, North Rhine-Westphalia, Germany

St. Barbara-Klinik Hamm

Hamm, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

St. Marien-Krankenhaus

Siegen, North Rhine-Westphalia, Germany

Gemeinschaftsklinikum Mittelrhein

Koblenz, Rhineland-Palatinate, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany

Universitätsklinikum Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Malteser Krankenhaus

Flensburg, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Zentralklinik Bad Berka

Bad Berka, Thuringia, Germany

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Thuringia, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Helios Kliniken

Berlin, Germany

Vivantes Klinikum Spandau

Berlin, Germany

Klinikum Bremen-Mitte

Bremen, Germany

Asklepios Klinik Altona

Hamburg, Germany