Clinical trial • Phase III • Haematology

Isatuximab for Multiple myeloma

Phase III trial of Isatuximab for Multiple myeloma.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Multiple myeloma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
05-07-2024
First CTIS Authorization Date
31-07-2024

Trial design

Randomised, open-label, induction comparator arms: arm ia (rvd) — lenalidomide 25 mg p.o. daily d1–14 and d22–35 per 42-day cycle; bortezomib 1.3 mg/m2 s.c. on days 1,4,8,11,22,25,29,32; dexamethasone 20 mg p.o. on days 1-2,4-5,8-9,11-12,15,22-23,25-26,29-30,32-33. arm ib: same rvd schedule as ia plus isatuximab 10 mg/kg i.v. (c1: days 1,8,15,22,29; c2-3: days 1,15,29). maintenance comparator arms: arm iia — lenalidomide maintenance 10 mg p.o. continuous (increase to 15 mg after 3 months if tolerated) with dexamethasone 20 mg p.o. in first cycle (days 1,8,15,22). arm iib — lenalidomide maintenance (10 mg p.o. continuous, increase to 15 mg after 3 months if tolerated) plus isatuximab 10 mg/kg i.v. (maintenance schedule: c1 days 1,8,15,22; c2-c3 days 1 and 15; c4+ day 1 every 28 days).-controlled Phase III trial in Germany.

Randomised
Yes
Open Label
Yes
Comparator
Induction comparator arms: Arm IA (RVd) — lenalidomide 25 mg p.o. daily d1–14 and d22–35 per 42-day cycle; bortezomib 1.3 mg/m2 s.c. on days 1,4,8,11,22,25,29,32; dexamethasone 20 mg p.o. on days 1-2,4-5,8-9,11-12,15,22-23,25-26,29-30,32-33. Arm IB: same RVd schedule as IA plus isatuximab 10 mg/kg i.v. (C1: days 1,8,15,22,29; C2-3: days 1,15,29). Maintenance comparator arms: Arm IIA — lenalidomide maintenance 10 mg p.o. continuous (increase to 15 mg after 3 months if tolerated) with dexamethasone 20 mg p.o. in first cycle (days 1,8,15,22). Arm IIB — lenalidomide maintenance (10 mg p.o. continuous, increase to 15 mg after 3 months if tolerated) plus isatuximab 10 mg/kg i.v. (maintenance schedule: C1 days 1,8,15,22; C2-C3 days 1 and 15; C4+ day 1 every 28 days).
Target Sample Size
662

Eligibility

Recruits 662 No vulnerable populations selected. Trial enrols adults aged 18-70 only. Written informed consent by the participant is required prior to enrolment. No assent/parental consent or minor-participant processes are described..

Pregnancy Exclusion
Pregnancy and lactation
Vulnerable Population
No vulnerable populations selected. Trial enrols adults aged 18-70 only. Written informed consent by the participant is required prior to enrolment. No assent/parental consent or minor-participant processes are described.

Inclusion criteria

  • {"criterion_text":"- Patients meeting all of the following criteria will be considered for admission to the trial:\n- Ability of patient to understand character and individual consequences of the clinical trial.\n- Provide written informed consent (must be available before enrolment in the trial).\n- Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy.\n- Patient is eligible for high dose therapy and autologous stem cell transplantation.\n- Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:34 • Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l) • Urine light-chain (M-protein) of ≥ 200 mg/24 hours • Serum FLC assay: involved sFLC level ≥ 10 mg/dl and abnormal sFLC ratio\n- Age 18 - 70 years inclusive\n- WHO performance status 0-2\n- Negative pregnancy test at inclusion (females of childbearing potential).\n- All patients must agree on the requirements regarding the lenalidomide pregnancy prevention plan described in section 6. For all men and females of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy.\n- All patients must • agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy • agree not to share study drug lenalidomide with another person and to return all unused study drug to the investigator or pharmacist"}

Exclusion criteria

  • {"criterion_text":"- Patients presenting with any of the following criteria will not be included in the trial:\n- Patients with active, uncontrolled infections\n- Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min)\n- Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)\n- Patients with a history of active malignancy during the past 5 years with the exception of the following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy (A history of an early stage malignancy during the past 5 years may be acceptable. In this case the GMMG study office has to be consulted prior to study inclusion.)\n- Patients with acute diffuse infiltrative pulmonary and/or pericardial disease\n- Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia\n- Platelet count < 75 x 10^9/l (Platelet transfusions are not permitted to improve platelet count prior to study inclusion.)\n- Haemoglobin ≤ 8.0 g/dl, unless related to myeloma\n- Absolute neutrophil count (ANC) < 1.0 x 10^9/l (the use of colony stimulating factors within 14 days before the test is not allowed)\n- Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l)\n- Patient has known hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids or H2 blockers that would prohibit further treatment with these agents.\n- Unable or unwilling to undergo thromboprophylaxis\n- Pregnancy and lactation\n- Participation in other clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.\n- Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.\n- Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)\n- Plasma cell leukemia\n- Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression or benign diseases, such as nonmalignant thyroid diseases. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma may be acceptable. In this case the GMMG study office has to be consulted prior to inclusion.\n- Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction < 40%.\n- Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert’s disease), unless related to myeloma.\n- Patients with active or history of hepatitis B or C (Prior hepatitis B may be acceptable if an adequate prophylaxis is being implemented during the course of the study.)\n- HIV positivity"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The study will investigate two primary endpoints:(1) minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity 1e-5), defined as proportion of patients with negative MRD after induction.","definition_or_measurement_approach":"Assessed by flow cytometry; sensitivity 1e-5. Defined as the proportion of patients with negative MRD after induction."}
  • {"endpoint_text":"- (2) progression-free survival (PFS), defined as time from 2nd randomization (prior to maintenance) to progression or death from any cause whichever occurs first.","definition_or_measurement_approach":"Time from 2nd randomization (prior to maintenance) to progression or death from any cause, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- Key Secondary Endpoint: PFS, defined as time from 1st randomization (at study inclusion) to progression or death from any cause whichever occurs first.","definition_or_measurement_approach":"PFS defined as time from 1st randomization to progression or death from any cause."}
  • {"endpoint_text":"- OS defined as time from 1st randomization and from 2nd randomization to time of death from any cause. Patients still being alive at the time of the analysis will be censored at the date last known to be alive.","definition_or_measurement_approach":"Overall survival measured from 1st randomization and from 2nd randomization to death; censoring at last known alive date."}
  • {"endpoint_text":"- Complete response (CR) rates. The analysis will be based on the CR rate which is the proportion of patients achieving complete response (CR) to treatment adjusted after removal of isatuximab interference in the immunofixation test in the relevant patient subpopulations.","definition_or_measurement_approach":"CR rate: proportion of patients achieving complete response adjusted for isatuximab interference in immunofixation."}
  • {"endpoint_text":"- MRD negativity after high dose therapy, during and after 3 years of maintenance treatment (flow cytometry) defined as the proportion of patients with negative MRD after high dose therapy, during and after 3 years of maintenance treatment (flow cytometry), respectively.","definition_or_measurement_approach":"Assessed by flow cytometry; proportion of patients with negative MRD after high dose therapy and during/after 3 years of maintenance."}
  • {"endpoint_text":"- Sustained MRD-negativity, defined as the maintenance of MRD-negativity (assessed by NGF at a sensitivity of 10-5) >=6 / >=12 months apart (after first occurrence of MRD negativity)","definition_or_measurement_approach":"Assessed by NGF at sensitivity 10^-5; sustained MRD-negativity defined as maintenance of MRD-negativity ≥6 months and ≥12 months apart after first occurrence."}
  • {"endpoint_text":"- best response to treatment during the trial (adjusted after removal of isatuximab interference in the immunofixation test in the relevant patient subpopulations).","definition_or_measurement_approach":"Best response to treatment during the trial, adjusted for isatuximab interference in immunofixation as applicable."}
  • {"endpoint_text":"- PFS 2 (PFS after next line of therapy) from 2nd randomization","definition_or_measurement_approach":"PFS2 measured from 2nd randomization to progression after the next line of therapy."}
  • {"endpoint_text":"- quality of life","definition_or_measurement_approach":"Quality of life assessments using EORTC-QLQC30, EORTC-QLQMY20, and EQ-5D-5L questionnaires (as described in protocol)."}

Recruitment

Planned Sample Size
662
Recruitment Window Months
101
Consent Approach
Written informed consent required from each participant prior to enrolment ("Provide written informed consent (must be available before enrolment in the trial)"). Trial enrols adults (Age 18-70); no assent or parental consent processes described. Subject information and informed consent forms are provided (documents L1_ICF_public and related ICF documents), language availability not specified in the provided records.

Geography

Total Number Of Sites
67
Total Number Of Participants
662

Germany

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
637
Number Of Sites
67
Number Of Participants
662

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
III. Medizinische Abteilung
Principal Investigator Name
Igor Wolfgang Blau
Principal Investigator Email
igor.blau@charite.de
Contact Person Name
Igor Wolfgang Blau
Contact Person Email
igor.blau@charite.de
Site Name
Rems-Murr-Kliniken gGmbH
Department Name
Rems-Murr-Kliniken gGmbH
Principal Investigator Name
Markus Schaich
Principal Investigator Email
markus.schaich@rems-murr-kliniken.de
Contact Person Name
Markus Schaich
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik Abtl. II
Principal Investigator Name
Britta Besemer
Principal Investigator Email
Britta.besemer@med.uni-tuebingen.de
Contact Person Name
Britta Besemer
Site Name
Studiengesellschaft Onkologie Bielefeld GbR
Department Name
Praxis
Principal Investigator Name
Hendrik Riesenberg
Principal Investigator Email
studien@onkologie-bielefeld.de
Contact Person Name
Hendrik Riesenberg
Contact Person Email
studien@onkologie-bielefeld.de
Site Name
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Department Name
Medizinische Universitätsklinik
Principal Investigator Name
Roland Schroers
Principal Investigator Email
roland.schroers@kk-bochum.de
Contact Person Name
Roland Schroers
Contact Person Email
roland.schroers@kk-bochum.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Virchow Klinikum
Principal Investigator Name
Igor-Wolfgang Balu
Principal Investigator Email
igor.blau@charite.de
Contact Person Name
Igor-Wolfgang Balu
Contact Person Email
igor.blau@charite.de
Site Name
Gemeinschaftspraxis für Hämatologie und Onkologie Lebach
Department Name
Gemeinschaftspraxis für Hämatologie und Onkologie
Principal Investigator Name
Stephan Kremers
Principal Investigator Email
katrinreus@onkologie-lebach.de
Contact Person Name
Stephan Kremers
Contact Person Email
katrinreus@onkologie-lebach.de
Site Name
HELIOS Klinikum Duisburg GmbH
Department Name
Medizinische Klinik II
Principal Investigator Name
Stela Theodoropoulou
Principal Investigator Email
stela.theodoropoulou@helios-gesundheit.de
Contact Person Name
Stela Theodoropoulou
Site Name
Zentrum für ambulante Hämatologie und Onkologie
Department Name
Zentrum für ambulante Hämatologie und Onkologie
Principal Investigator Name
Stefan Fronhoffs
Principal Investigator Email
sfronhoffs@zaho-rheinland.de
Contact Person Name
Stefan Fronhoffs
Contact Person Email
sfronhoffs@zaho-rheinland.de
Site Name
MVZ CCB Frankfurt Und Main-Taunus GbR
Department Name
Centrum für Hämatologie und Onkologie Bethanien
Principal Investigator Name
Christian Schmitt
Principal Investigator Email
Christian.schmitt@telemed.de
Contact Person Name
Christian Schmitt
Contact Person Email
Christian.schmitt@telemed.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
2. Medizinische Abteilung Onkologie mit Sektion Hämatologie
Principal Investigator Name
Hans-Jürgen Salwender
Principal Investigator Email
h.salwender@asklepios.com
Contact Person Name
Hans-Jürgen Salwender
Contact Person Email
h.salwender@asklepios.com
Site Name
Kliniken Maria Hilf GmbH Moenchengladbach
Department Name
Medizinische Klinik I
Principal Investigator Name
Ullrich Graeven
Principal Investigator Email
Ullrich.Graeven@mariahilf.de
Contact Person Name
Ullrich Graeven
Contact Person Email
Ullrich.Graeven@mariahilf.de
Site Name
Bundeswehrkrankenhaus Ulm
Department Name
Abteilung Innere Medizin – Hämatologie und internistische Onkologie
Principal Investigator Name
Armin Riecke
Principal Investigator Email
arminriecke@bundeswehr.org
Contact Person Name
Armin Riecke
Contact Person Email
arminriecke@bundeswehr.org
Site Name
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Peter Reimer
Principal Investigator Email
p.reimer@evk-werden.de
Contact Person Name
Peter Reimer
Contact Person Email
p.reimer@evk-werden.de
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik für Hämatologie, Onkologie und Immunologie
Principal Investigator Name
Snjezana Janjetovic
Principal Investigator Email
Snjezana.janjetovic@helios-gesundheit.de
Contact Person Name
Snjezana Janjetovic
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Med. Klinik III, Hämatologie und Onkologie
Principal Investigator Name
Miriam Ahlborn
Principal Investigator Email
m.ahlborn@klinikum-braunschweig.de
Contact Person Name
Miriam Ahlborn
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik III
Principal Investigator Name
Sebastian Schlaweck
Principal Investigator Email
Sebastian.Schlaweck@ukbonn.de
Contact Person Name
Sebastian Schlaweck
Contact Person Email
Sebastian.Schlaweck@ukbonn.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie
Principal Investigator Name
Amelie Boquoi
Principal Investigator Email
Amelie.boquoi@uk-essen.de
Contact Person Name
Amelie Boquoi
Contact Person Email
Amelie.boquoi@uk-essen.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik V
Principal Investigator Name
Hartmuth Goldschmidt
Principal Investigator Email
S.GMMG@med.uni-heidelberg.de
Contact Person Name
Hartmuth Goldschmidt
Contact Person Email
S.GMMG@med.uni-heidelberg.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie Studienzentrale der II. Medizinischen Klinik
Principal Investigator Name
Katja Weisel
Principal Investigator Email
k.weisel@uke.de
Contact Person Name
Katja Weisel
Contact Person Email
k.weisel@uke.de
Site Name
HELIOS Klinikum Bad Saarow GmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Daniel Schöndube
Principal Investigator Email
daniel.schoendube@helios-gesundheit.de
Contact Person Name
Daniel Schöndube
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Innere Medizin III
Principal Investigator Name
Mathias Hänel
Principal Investigator Email
m.haenel@skc.de
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Onkologische Schwerpunktpraxis Heidelberg
Department Name
Onkologische Schwerpunktpraxis Heidelberg
Principal Investigator Name
Daniel Debatin
Principal Investigator Email
daniel.debatin@onko-heidelberg.de
Contact Person Name
Daniel Debatin
Site Name
Klinikum Osnabrueck GmbH
Department Name
Medizinische Klinik III
Principal Investigator Name
Martin Kropff
Principal Investigator Email
martin.kropff@klinikum-os.de
Contact Person Name
Martin Kropff
Contact Person Email
martin.kropff@klinikum-os.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV
Principal Investigator Name
Mathias Rummel
Principal Investigator Email
mathias.rummel@innere.med.uni-giessen.de
Contact Person Name
Mathias Rummel
Site Name
Onkologisches Studienzentrum Darmstadt
Department Name
Onkologisches Studienzentrum
Principal Investigator Name
Gerrit Dingeldein
Principal Investigator Email
g.dingeldein@onkologie-darmstadt.de
Contact Person Name
Gerrit Dingeldein
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
III. Medizinische Klinik
Principal Investigator Name
Stefan Klein
Principal Investigator Email
stefan.klein@umm.de
Contact Person Name
Stefan Klein
Contact Person Email
stefan.klein@umm.de
Site Name
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Department Name
Institut für Klinisch-Onkologische Forschung
Principal Investigator Name
Eckhart Weidmann
Principal Investigator Email
weidmann.eckhart@khnw.de
Contact Person Name
Eckhart Weidmann
Contact Person Email
weidmann.eckhart@khnw.de
Site Name
Klinikum Darmstadt GmbH
Department Name
Medizinische Klinik V
Principal Investigator Name
Helga Bernhard
Principal Investigator Email
helga.bernhard@mail.klinikum-darmstadt.de
Contact Person Name
Helga Bernhard
Site Name
Universitaet Leipzig
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Song-Yau Wang
Principal Investigator Email
song-yau.wang@medizin.uni-leipzig.de
Contact Person Name
Song-Yau Wang
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Principal Investigator Name
Deniz Gezer
Principal Investigator Email
dgezer@ukaachen.de
Contact Person Name
Deniz Gezer
Contact Person Email
dgezer@ukaachen.de
Site Name
Onkologische Schwerpunktpraxis Speyer
Department Name
Onkologische Praxis Speyer
Principal Investigator Name
Joachim Behringer
Principal Investigator Email
j.behringer@onkologie-speyer.de
Contact Person Name
Joachim Behringer
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik
Principal Investigator Name
Christian Michel
Principal Investigator Email
Christian.michel@unimedizin-mainz.de
Contact Person Name
Christian Michel
Site Name
Diakonie-Klinikum Schwaebisch Hall gGmbH
Department Name
Innere Medizin III
Principal Investigator Name
Thomas Geer
Principal Investigator Email
Thomas.geer@diakoneo.de
Contact Person Name
Thomas Geer
Contact Person Email
Thomas.geer@diakoneo.de
Site Name
Katholisches Krankenhaus Hagen gGmbH
Department Name
Hämatologie/Onkologie
Principal Investigator Name
Doris Kraemer
Principal Investigator Email
info@kkh-hagen.de
Contact Person Name
Doris Kraemer
Contact Person Email
info@kkh-hagen.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Marien Hospital Herne
Principal Investigator Name
Dirk Strumberg
Principal Investigator Email
Dirk.strumberg@elisabethgruppe.de
Contact Person Name
Dirk Strumberg
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik A
Principal Investigator Name
Evgenii Shumilov
Principal Investigator Email
Evgenii.shumilov@ukmuenster.de
Contact Person Name
Evgenii Shumilov
Contact Person Email
Evgenii.shumilov@ukmuenster.de
Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
Praxisklinik für Hämatologie und Onkologie
Principal Investigator Name
Rudolf Weide
Principal Investigator Email
weide@invo-koblenz.de
Contact Person Name
Rudolf Weide
Contact Person Email
weide@invo-koblenz.de
Site Name
Zentrum für ambulante Hämatologie und Onkologie (ZAHO)
Department Name
Praxis
Principal Investigator Name
Walter Verbeek
Principal Investigator Email
wverbeek@zaho-rheinland.de
Contact Person Name
Walter Verbeek
Contact Person Email
wverbeek@zaho-rheinland.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Hämatologie, Onkologie und klinische Immunologie
Principal Investigator Name
Roland Fenk
Principal Investigator Email
fenk@med.uni-duesseldorf.de
Contact Person Name
Roland Fenk
Contact Person Email
fenk@med.uni-duesseldorf.de
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
2. Medizinische Klinik
Principal Investigator Name
Martin Schmidt-Hieber
Principal Investigator Email
M.Schmidt_Hieber@mul-ct.de
Contact Person Name
Martin Schmidt-Hieber
Contact Person Email
M.Schmidt_Hieber@mul-ct.de
Site Name
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Tobias Gaska
Principal Investigator Email
onkologie@bk-paderborn.de
Contact Person Name
Tobias Gaska
Contact Person Email
onkologie@bk-paderborn.de
Site Name
Philipps-Universitaet Marburg
Department Name
Hämatologie/Onkologie/ Immunologie
Principal Investigator Name
Christoph Mann
Principal Investigator Email
mannch@staff.uni-marburg.de
Contact Person Name
Christoph Mann
Contact Person Email
mannch@staff.uni-marburg.de
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Principal Investigator Name
Frank Ruecker
Principal Investigator Email
frank.ruecker@mutterhaus.de
Contact Person Name
Frank Ruecker
Contact Person Email
frank.ruecker@mutterhaus.de
Site Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Department Name
Innere Medizin II
Principal Investigator Name
Paul La Rosée
Principal Investigator Email
paul.laRosee@sbk-vs.de
Contact Person Name
Paul La Rosée
Contact Person Email
paul.laRosee@sbk-vs.de
Site Name
St.-Antonius-Hospital gGmbH
Department Name
Klinik für Hämatologie / Onkologie
Principal Investigator Name
Peter Staib
Principal Investigator Email
peter.staib@sah-eschweiler.de
Contact Person Name
Peter Staib
Contact Person Email
peter.staib@sah-eschweiler.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Karolin Trautmann-Grill
Principal Investigator Email
karolin.trautmann@uniklinikum-dresden.de
Contact Person Name
Karolin Trautmann-Grill
Site Name
Westpfalz-Klinikum GmbH
Department Name
Klinik für Innere Medizin 1
Principal Investigator Name
Gerhard Held
Principal Investigator Email
gheld@westpfalz-klinikum.de
Contact Person Name
Gerhard Held
Contact Person Email
gheld@westpfalz-klinikum.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
SLK-Kliniken Heilbronn GmbH
Principal Investigator Name
Uwe Martens
Principal Investigator Email
uwe.martens@slk-kliniken.de
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slk-kliniken.de
Site Name
Marien Hospital Duesseldorf GmbH
Department Name
Klinik für Onkologie, Hämatologie und Palliativmedizin
Principal Investigator Name
Maika Klaiber-Hakimi
Principal Investigator Email
Maika.Klaiber-Hakimi@vkkd-kliniken.de
Contact Person Name
Maika Klaiber-Hakimi
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
Klinik für Onkologie und Hämatologie
Principal Investigator Name
Bernhard Heilmeier
Contact Person Name
Bernhard Heilmeier
Site Name
Vita 34 AG
Department Name
Gemeinschaftspraxis
Principal Investigator Name
Michael Kiehl
Principal Investigator Email
michael.kiehl@klinikumffo.de
Contact Person Name
Michael Kiehl
Contact Person Email
michael.kiehl@klinikumffo.de
Site Name
Johanniter GmbH
Department Name
Johanniter Krankenhaus Bonn
Principal Investigator Name
Yon-Dschun Ko
Principal Investigator Email
yon-dschun.ko@bn.johanniter-kliniken.de
Contact Person Name
Yon-Dschun Ko
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Principal Investigator Name
Christoph Scheid
Principal Investigator Email
Christoph.scheid@uk-koeln.de
Contact Person Name
Christoph Scheid
Contact Person Email
Christoph.scheid@uk-koeln.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Tumorzentrum Eva Mayr-Stihl
Principal Investigator Name
Claudia Riechel
Principal Investigator Email
c.riechel@klinikum-stuttgart.de
Contact Person Name
Claudia Riechel
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II
Principal Investigator Name
Ivana von Metzler
Principal Investigator Email
Metzler@med.uni-frankfurt.de
Contact Person Name
Ivana von Metzler
Contact Person Email
Metzler@med.uni-frankfurt.de
Site Name
Klinikum Fulda gAG
Department Name
Klinisches Studienzentrum GmbH
Principal Investigator Name
Philippe Kostrewa
Principal Investigator Email
Philippe.kostrewa@klinikum-fulda.de
Contact Person Name
Philippe Kostrewa
Site Name
Universitaet Des Saarlandes
Department Name
Klinik IMED 41.1
Principal Investigator Name
Jörg Thomas Bittenbring
Principal Investigator Email
Joerg.thomas.bittenbring@uks.eu
Contact Person Name
Jörg Thomas Bittenbring
Site Name
Katholisches Karl-Leisner-Klinikum gGmbH
Department Name
Klinik für Innere Medizin
Principal Investigator Name
Volker Runde
Principal Investigator Email
volker.runde@kkle.de
Contact Person Name
Volker Runde
Contact Person Email
volker.runde@kkle.de
Site Name
Mannheimer Onkologie Praxis
Department Name
Onkologie Praxis
Principal Investigator Name
Manfred Hensel
Principal Investigator Email
hensel@mannheimer-onkologie-praxis.de
Contact Person Name
Manfred Hensel
Site Name
Asklepios Klinik St George
Department Name
Abt. für Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Hans Salwender
Principal Investigator Email
h.salwender@asklepios.com
Contact Person Name
Hans Salwender
Contact Person Email
h.salwender@asklepios.com
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Maike de Wit
Principal Investigator Email
Maike.deWit@vivantes.de
Contact Person Name
Maike de Wit
Contact Person Email
Maike.deWit@vivantes.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizin 5
Principal Investigator Name
Barbara Ferstl
Principal Investigator Email
Barbara.Ferstl@uk-erlangen.de
Contact Person Name
Barbara Ferstl
Contact Person Email
Barbara.Ferstl@uk-erlangen.de
Site Name
Muehlenkreiskliniken AöR
Department Name
Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin
Principal Investigator Name
Hans-Joachim Tischler
Contact Person Name
Hans-Joachim Tischler
Site Name
Klinikum Frankfurt (Oder) GmbH
Department Name
Medizinische Klinik I
Principal Investigator Name
Olaf Hopfer
Principal Investigator Email
olaf.hopfer@klinikumffo.de
Contact Person Name
Olaf Hopfer
Contact Person Email
olaf.hopfer@klinikumffo.de
Site Name
Klinikum Region Hannover GmbH
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Martin Müller
Principal Investigator Email
Martin.mueller@krh.eu
Contact Person Name
Martin Müller
Contact Person Email
Martin.mueller@krh.eu
Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
Medizinische Klinik A
Principal Investigator Name
Martin Hoffmann
Principal Investigator Email
HoffmanM@klilu.de
Contact Person Name
Martin Hoffmann
Contact Person Email
HoffmanM@klilu.de

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Heidelberg AöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Third parties

  • {"country":"","full_name":"Bristol Myers Squibb (Celgene)","duties_or_roles":"Monetary support / source of monetary support","organisation_type":""}
  • {"country":"","full_name":"Sanofi-Aventis Deutschland GmbH","duties_or_roles":"Monetary support / source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Isatuximab
Active Substance
Isatuximab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
10 mg/kg i.v. (induction and maintenance schedules as per protocol)
Dose Levels
Induction: 10 mg/kg i.v. C1: days 1, 8, 15, 22, 29; C2-3: days 1, 15, 29. Maintenance: 10 mg/kg i.v. C1: days 1,8,15,22; C2-3: days 1 and 15; C4+ day 1 every 28 days.
Frequency
Multiple infusions per cycle as specified (see dose_levels)
Maximum Dose
10 mg/kg (maxDailyDoseAmount reported 10 mg/kg)
Investigational Product Name
Lenalidomide
Active Substance
Lenalidomide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Starting Dose
25 mg p.o. daily during induction (days 1-14 and days 22-35 per 42-day cycle); Maintenance: 10 mg p.o. daily (increase to 15 mg after 3 months if tolerated)
Dose Levels
Induction: 25 mg/day p.o. d1–14 and d22–35 per 42-day cycle. Maintenance: 10 mg/day continuous, increase to 15 mg/day after 3 months if tolerated.
Frequency
Daily as per schedule
Maximum Dose
25 mg (maxDailyDoseAmount reported 25 mg)
Investigational Product Name
VELCADE (Bortezomib)
Active Substance
Bortezomib
Modality
Small molecule
Routes Of Administration
Subcutaneous injection (solution for injection)
Route
Subcutaneous
Authorisation Status
Authorised (marketing authorisation present for product listed)
Starting Dose
1.3 mg/m2 s.c. per administration (as used in induction schedule)
Dose Levels
Bortezomib 1.3 mg/m2 s.c. on days 1, 4, 8, 11, 22, 25, 29, 32 (induction schedule)
Frequency
Multiple doses per 42-day cycle as specified
Maximum Dose
1.3 mg/m2 (maxDailyDoseAmount reported 1.3 mg/m2)
Investigational Product Name
Dexamethasone
Active Substance
Dexamethasone
Modality
Small molecule (corticosteroid)
Routes Of Administration
Oral (and i.v. for some maintenance descriptions)
Route
Oral (and intravenous where specified)
Authorisation Status
Authorised
Starting Dose
20 mg p.o. (induction and maintenance schedules vary; e.g., induction: 20 mg/d on specified days; maintenance first cycle days 1,8,15,22)
Dose Levels
Induction: dexamethasone p.o. 20 mg/d on specified days (see protocol). Maintenance: dexamethasone 20 mg p.o. (first cycle days 1,8,15,22) or 20 mg i.v. as specified for Arm IIB first cycle.
Frequency
Intermittent per cycle as specified
Maximum Dose
20 mg (maxDailyDoseAmount reported 20 mg)
Combination Treatment
Yes

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