Trial Title:
Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma
NCT ID:
NCT05804032
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Bortezomib
Antibodies, Monoclonal
Conditions: Keywords:
Neoplasms
Paraproteinemias
Lymphoproliferative Disorders
Immunoproliferative Disorders
Lenalidomide
Bortezomib
Dexamethasone
Isatuximab
Monoclonal antibodies
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Isatuximab
Description:
IV isatuximab will be administered weekly in the first cycle (Cycle 1) on days 1, 8, 15,
22, 29, and biweekly on the 2 subsequent cycles at days 1, 15 and 29, at the dose of 10
mg/kg.
Arm group label:
Arm A - Intravenous isatuximab
Other name:
Sarclisa
Intervention type:
Drug
Intervention name:
Isatuximab
Description:
SC isatuximab will be administered on days 1, 8, 15, 22, 29 of cycle 1, and on days 1, 15
and 29 of cycles 2-3, at the dose of 1400 mg
Arm group label:
Arm B - Subcutaneous isatuximab
Other name:
Sarclisa
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Both arms: 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3
Arm group label:
Arm A - Intravenous isatuximab
Arm group label:
Arm B - Subcutaneous isatuximab
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Both arms: 1.3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction
cycles
Arm group label:
Arm A - Intravenous isatuximab
Arm group label:
Arm B - Subcutaneous isatuximab
Other name:
Velcade
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
20 mg per os on day 1-2, 4-5, 8-9, 11-12, 15; and 22-23, 25-26, 29-30, 32-33 in induction
cycles 1-3.
Arm group label:
Arm A - Intravenous isatuximab
Arm group label:
Arm B - Subcutaneous isatuximab
Summary:
The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous
isatuximab administration in transplant-eligible patients with newly diagnosed multiple
myeloma.
Detailed description:
Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for
patients with confirmed diagnosis of untreated multiple myeloma requiring systemic
therapy.
Investigational Medicinal Product: Isatuximab, subcutaneous administration via a wearable
injector system.
Randomization: Patients are randomized in one of 2 study arms (A or B) before induction
therapy. Patients randomized in arm A will receive 3 cycles of the monoclonal antibody
isatuximab intravenously, combined with RVd regimen (Lenalidomide, Bortezomib,
Dexamethasone). Each cycle will last for 42 days. Patients in arm B will receive 3 cycles
RVd plus isatuximab subcutaneously. After induction therapy, patients will receive
standard intensification (usually cyclophosphamide-based mobilization therapy, stem cell
collection and high-dose melphalan followed by autologous stem cell transplantation
(HDM/ASCT)). End of study will be after the first HDM/ASCT.
There is one primary objective:
Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous
(IV) isatuximab, both in combination with RVd, with respect to rates of VGPR or better
after induction therapy (according to standard International Myeloma Working Group (IMWG)
response criteria).
Key secondary objectives are:
1. Comparison of patient-reported outcomes (PRO) regarding route of administration of
isatuximab (SC vs. IV) on induction therapy as assessed by modified CTSQ (modified
9-item questionnaire).
2. Non-inferiority of rates of MRD negativity (assessed by NGS from BMA; sensitivity
10^-5) independent of standard IMWG response after induction therapy.
The duration of the trial for each patients is expected to be approximately 10 months
(induction and intensification treatment).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria
according to IMWG)
- Patient is eligible for high-dose melphalan (200 mg/m^2 melphalan) and autologous
stem cell transplantation
- Measurable MM disease according to IMWG criteria, defined as any quantifiable
monoclonal protein value, defined by at least one of the following three
measurements: serum M-protein ≥ 10 g/L; urine light-chain (M-protein) of ≥ 200 mg/24
hours; involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal
- Age 18-70 years at trial inclusion
Exclusion Criteria:
- Patient has known hypersensitivity (or contraindication) to any of the components of
study therapy
- Systemic amyloid light-chain amyloidosis (except for localized AL amyloidosis
limited to the skin or the bone marrow)
- Plasma cell leukemia
- Previous chemotherapy or radiotherapy during the past 5 years except local
radiotherapy in case of local MM progression
- Severe cardiac dysfunction (NYHA classification III-IV)
- Patients with active or uncontrolled hepatitis B or C or detectable liver disease
due to hepatitis B or C
- HIV positivity
- Patients with active, uncontrolled infections
- Patients with severe renal insufficiency or requiring hemodialysis
- Patients with peripheral neuropathy or neuropathic pain, grade 2 or higher (as
defined by the NCI Common Terminology Criteria for Adverse Events)
- Patients with a history of any active malignancy during the past 5 years with the
exception of following malignancies after curative therapy: basal cell carcinoma of
the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ
malignancy
- Platelet count < 75 x 10^9/L
- Haemoglobin ≤ 8.0 g/dL, unless related to MM
- 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)
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
- Pregnancy and lactation
For further details on inclusion/exclusion criteria please refer to the study protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinikum Krems
Address:
City:
Krems
Zip:
3500
Country:
Austria
Status:
Recruiting
Facility:
Name:
Ordensklinikum Linz
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Landeskrankenhaus Feldkirch-Rankweil
Address:
City:
Rankweil
Zip:
6830
Country:
Austria
Status:
Recruiting
Facility:
Name:
Universitätsklinikum der Paracelsus, 3. Med. Abteilung/Onkologie Ambulanz
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Universitätsklinikum St. Pölten - Lilienfeld
Address:
City:
St. Pölten
Zip:
3100
Country:
Austria
Status:
Recruiting
Facility:
Name:
Phyrn-Eisenwurzen Klinikum Steyr
Address:
City:
Steyr
Zip:
4400
Country:
Austria
Status:
Recruiting
Facility:
Name:
Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Augsburg, II. Medizinische Klinik Hämatologie/Onkologie
Address:
City:
Augsburg
Zip:
86156
Country:
Germany
Status:
Recruiting
Facility:
Name:
Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin
Address:
City:
Bad Saarow
Zip:
15526
Country:
Germany
Status:
Recruiting
Facility:
Name:
MedZentrum Klinikum Bayreuth GmbH
Address:
City:
Bayreuth
Zip:
95445
Country:
Germany
Status:
Recruiting
Facility:
Name:
Charité, III. Medizinische Abteilung (Hämatologie/Onkologie)
Address:
City:
Berlin
Zip:
12200
Country:
Germany
Status:
Recruiting
Facility:
Name:
Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie
Address:
City:
Berlin
Zip:
12351
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinik für Hämatologie und Stammzelltransplantation, Helios Klinikum Berlin-Buch
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Facility:
Name:
Vivantes Klinikum Spandau
Address:
City:
Berlin
Zip:
13585
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Bielefeld Praxis, Studiengesellschaft Onkologie
Address:
City:
Bielefeld
Zip:
33604
Country:
Germany
Status:
Recruiting
Facility:
Name:
Evangelisches Klinikum Bethel
Address:
City:
Bielefeld
Zip:
33611
Country:
Germany
Status:
Recruiting
Facility:
Name:
Johanniter-Krankenhaus Bonn
Address:
City:
Bonn
Zip:
53113
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Bonn, Medizinische Klinik III
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Status:
Recruiting
Facility:
Name:
Städtisches Klinikum Braunschweig
Address:
City:
Braunschweig
Zip:
38114
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Klinikum Bremen-Mitte
Address:
City:
Bremen
Zip:
28205
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Chemnitz gGmbH
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Recruiting
Facility:
Name:
Carl-Thiem-Klinikum Cottbus gGmbH, 2. Medizinische Klinik
Address:
City:
Cottbus
Zip:
03048
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Darmstadt, Medizinische Klinik V Hämatologie/Onkologie
Address:
City:
Darmstadt
Zip:
64283
Country:
Germany
Status:
Recruiting
Facility:
Name:
St.-Johannes-Hospital
Address:
City:
Dortmund
Zip:
44137
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Helios St. Johannes Klinik Duisburg, Medizinische Klinik 2
Address:
City:
Duisburg
Zip:
47166
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie
Address:
City:
Düsseldorf
Zip:
40225
Country:
Germany
Status:
Recruiting
Facility:
Name:
Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatalogie und Palliativmedizin
Address:
City:
Düsseldorf
Zip:
40479
Country:
Germany
Status:
Recruiting
Facility:
Name:
St. Antonius-Hospital Eschweiler, Klinik für Hämatologie / Onkologie
Address:
City:
Eschweiler
Zip:
52249
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
KEM I Evang. Kliniken Essen-Mitte gGmbH, Evangelisches Krankenhaus Essen-Werden gGmbH, Klinik für Hämatologie, Onkologie und Stammzelltransplantation
Address:
City:
Essen
Zip:
45239
Country:
Germany
Status:
Recruiting
Facility:
Name:
Malteser Krankenhaus, St. Franziskus Hospital, Hämatologie/Onkologie
Address:
City:
Flensburg
Zip:
24939
Country:
Germany
Status:
Recruiting
Facility:
Name:
Centrum für Hämatologie und Onkologie Bethanien
Address:
City:
Frankfurt am Main
Zip:
60389
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Frankfurt, Medizinische Klinik 2, Hämatologie/Onkologie
Address:
City:
Frankfurt am Main
Zip:
60590
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Freiburg
Address:
City:
Freiburg
Zip:
79110
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C
Address:
City:
Greifswald
Zip:
17475
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Göttingen
Address:
City:
Göttingen
Zip:
37075
Country:
Germany
Status:
Recruiting
Facility:
Name:
Katholisches Krankenhaus Hagen gGmbH, Klinik für Hämatologie und Onkologie
Address:
City:
Hagen
Zip:
58097
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Halle
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Asklepios Kliniken Hamburg GmbH
Address:
City:
Hamburg-Altona
Zip:
20099
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Facility:
Name:
Onkologische Schwerpunktpraxis Heidelberg
Address:
City:
Heidelberg
Zip:
69115
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Heidelberg, Medizinische Klinik V
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Facility:
Name:
SLK Kliniken Heilbronn, Medizinische Klinik III
Address:
City:
Heilbronn
Zip:
74078
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin 1
Address:
City:
Homburg
Zip:
66421
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II, Abteilung Hämatologie und internistische Onkologie
Address:
City:
Jena
Zip:
07740
Country:
Germany
Status:
Recruiting
Facility:
Name:
Westpfalz-Klinikum
Address:
City:
Kaiserslautern
Zip:
67655
Country:
Germany
Status:
Recruiting
Facility:
Name:
Städtisches Klinikum Karlsruhe
Address:
City:
Karlsruhe
Zip:
76133
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikverbund Allgäu, Klinikum Kempten, Hämatologie / Onkologie
Address:
City:
Kempten
Zip:
87439
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Gemeinschaftsklinikum Mittelrhein
Address:
City:
Koblenz
Zip:
56073
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Köln
Address:
City:
Köln
Zip:
50937
Country:
Germany
Status:
Recruiting
Facility:
Name:
Gemeinschaftspraxis für Hämatologie und Onkologie
Address:
City:
Lebach
Zip:
66822
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Leipzig
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum der Stadt Ludwigshafen
Address:
City:
Ludwigshafen
Zip:
67063
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Address:
City:
Lübeck
Zip:
23538
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Magdeburg
Address:
City:
Magdeburg
Zip:
39120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Medizinische Klinik und Poliklinik
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Facility:
Name:
Mannheimer Onkologie Praxis
Address:
City:
Mannheim
Zip:
68161
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Mannheim, III. Medizinische Klinik
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Facility:
Name:
Philipps-Universität Marburg, Abteilung Hämatologie, Onkologie und Immunologie am Universitätsklinikum Gießen und Marburg GmbH
Address:
City:
Marburg
Zip:
35037
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Hochsauerland
Address:
City:
Meschede
Zip:
59870
Country:
Germany
Status:
Recruiting
Facility:
Name:
Kliniken Ostalb - Standort Stauferklinikum, Hämatologie und Onkologie
Address:
City:
Mutlangen
Zip:
73557
Country:
Germany
Status:
Recruiting
Facility:
Name:
Kliniken Maria Hilf GmbH, Medizinische Klinik I
Address:
City:
Mönchengladbach
Zip:
41063
Country:
Germany
Status:
Recruiting
Facility:
Name:
Rotkreuzklinikum
Address:
City:
München
Zip:
80634
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Münster, 1. Medizinische Klinik A
Address:
City:
Münster
Zip:
48149
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinik Oldenburg
Address:
City:
Oldenburg
Zip:
26133
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Osnabrück
Address:
City:
Osnabrück
Zip:
49076
Country:
Germany
Status:
Recruiting
Facility:
Name:
Brüderkrankenhaus St. Josef
Address:
City:
Paderborn
Zip:
33098
Country:
Germany
Status:
Recruiting
Facility:
Name:
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
Address:
City:
Regensburg
Zip:
93049
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III (Tumorerkrankungen, Palliativmedizin)
Address:
City:
Schwäbisch Hall
Zip:
74523
Country:
Germany
Status:
Recruiting
Facility:
Name:
ZAHO-Zentrum für ambulante Hämatologie und Onkologie
Address:
City:
Siegburg
Zip:
53721
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Zentrum für ambulante Hämatologie und Onkologie (ZAHO)
Address:
City:
Siegburg
Zip:
53721
Country:
Germany
Status:
Recruiting
Facility:
Name:
Onkologische Schwerpunktpraxis Speyer
Address:
City:
Speyer
Zip:
67346
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital
Address:
City:
Stuttgart
Zip:
70174
Country:
Germany
Status:
Recruiting
Facility:
Name:
Robert-Bosch-Krankenhaus
Address:
City:
Stuttgart
Zip:
70376
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universität Tübingen, Medizinische Universitätsklinik, Innere Medizin II: Onkologie, Hämatologie, Klinische Immunologie und Rheumatologie
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Ulm
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Facility:
Name:
University of Würzburg, Med. Klinik und Poliklinik II
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Start date:
April 14, 2023
Completion date:
July 24, 2026
Lead sponsor:
Agency:
University of Heidelberg Medical Center
Agency class:
Other
Collaborator:
Agency:
Deutsche Studiengruppe Multiples Myelom (DSMM)
Agency class:
Other
Collaborator:
Agency:
KKS Netzwerk
Agency class:
Other
Collaborator:
Agency:
Sanofi
Agency class:
Industry
Source:
University of Heidelberg Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05804032
