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NCT03617731

PHASE3

Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)

Sponsor: University of Heidelberg Medical Center

View on ClinicalTrials.gov

Summary

Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide/bortezomib/dexamethasone (RVd) and in lenalidomide maintenance treatment

Official title: A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

662

Start Date

2018-10-18

Completion Date

2028-06

Last Updated

2026-02-03

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

DRUG

Lenalidomide

25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB)

DRUG

Bortezomib

all arms: 1,3 mg/m\^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles

DRUG

Dexamethasone

20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 and 22,23 and 25,26 and 29,30 and 32,33 in induction cycles 1-3 (Arms IA and IB). Maintenance cycle 1 on day 1, 8, 15, 22 Dexamethasone 20 mg/d per os (Arm IIA). In Arm IIB Dexamethasone 20 mg i.v. on days of Isatuximab infusion in the first maintenance cycle (d 1, 8, 15, 22), dexamethasone will be administered intravenously as part of the premedication. If an isatuximab dose is skipped or discontinued dexamethasone should be administered orally.

DRUG

Isatuximab

10 mg/kg in the vein( i.v) on day 1,8,15, 22, 29 in induction cycle 1 on day 1, 15 and 29 in induction cycle 2 and 3 (Arm IB). 10 mg/kg i.v. on day 1,8, 15 and 22 in maintenance cycle 1, 10 mg/kg i.v. on day 1 and 15 in maintenance cycle 2 and 3, 10 mg/kg i.v. on day 1 in maintenance cycle 4 - 39 (Arm IIB)

Inclusion Criteria: 1. Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (diagnostic criteria (IMWG updated criteria (2014)1) see appendix IA. For some patients systemic therapy may be required though these diagnostic criteria are not fulfilled. In this case the GMMG study office has to be consulted prior to inclusion.) 2. Patient is eligible for high dose therapy and autologous stem cell transplantation. 3. Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:2 * Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l) * Urine light-chain (M-protein) of ≥ 200 mg/24 hours * Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal 4. Age 18 - 70 years inclusive 5. WHO performance status 0-2 6. Negative pregnancy test at inclusion (females of childbearing potential) 7. 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. 8. 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 9. Ability of patient to understand character and individual consequences of the clinical trial 10. Provide written informed consent (must be available before enrolment in the trial) Exclusion Criteria 1. 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. 2. Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow) 3. Plasma cell leukemia 4. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression. (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 5. Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction \< 40% 6. 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. 7. Patients with active or history of hepatitis B or C 8. HIV positivity 9. Patients with active, uncontrolled infections 10. Patients with severe renal insufficiency (Creatinine Clearance \< 30ml/min) 11. 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) 12. Patients with a history of 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 13. Patients with acute diffuse infiltrative pulmonary and/or pericardial disease 14. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia 15. Platelet count \< 75 x 109/l 16. Haemoglobin \< 8.0 g/dl, unless related to myeloma 17. Absolute neutrophil count (ANC) \< 1.0 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed) 18. Corrected serum calcium \> 14 mg/dl (\> 3.5 mmol/l) 19. Unable or unwilling to undergo thromboprophylaxis 20. Pregnancy and lactation 21. 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. 22. 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. No patients will be allowed to enrol in this trial more than once. \-

Locations (72)

Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

Aachen, Germany

Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin

Bad Saarow, Germany

Charité, Campus Benjamin Franklin , III. Medizinische Abteilung (Hämatologie/Onkologie)

Berlin, Germany

Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

Berlin, Germany

HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

Berlin, Germany

Studiengesellschaft Onkologie Bielefeld GbR

Bielefeld, Germany

Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

Bielefeld, Germany

Medizinische Universitätsklinik, Knappschaftskrankenhaus

Bochum, Germany

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie

Bonn, Germany

Johanniter Krankenhaus Bonn

Bonn, Germany

Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

Bonn, Germany

Städtisches Klinikum Braunschweig, Med. Klinik III, Hämatologie und Onkologie

Braunschweig, Germany

Klinikum Chemnitz GmbH, Innere Medizin III

Chemnitz, Germany

Uniklinik Köln, Klinik I für Innere Medizin

Cologne, Germany

Carl-Thiem-Klinikum Cottbus gGmbH, II. Medizinische Klinik

Cottbus, Germany

Onkologisches Studienzentrum Darmstadt

Darmstadt, Germany

Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

Darmstadt, Germany

Universitätsklinikum Carl Gustav Carus Dresden, an der Technischen Universität Dresden, Medizinische Klinik und Poliklinik I

Dresden, Germany

HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf

Duisburg, Germany

Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatologie und Palliativmedizin

Düsseldorf, Germany

Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie

Düsseldorf, Germany

Universitätsklinik Erlangen

Erlangen, Germany

St. Antonius-Hospital Eschweiler, Klinik für Hämatologie / Onkologie

Eschweiler, Germany

Universitätsklinikum Essen, Klinik für Hämatologie

Essen, Germany

Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

Essen, Germany

Gemeinschaftspraxis Prof. Dr. Michael Kiehl und Dipl. Med. Wolfgang Stein

Frankfurt (Oder), Germany

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Germany

Agaplesion Markus Krankenhaus, Med. Klinik I

Frankfurt am Main, Germany

Krankenhaus Nordwest, Institut für Klinisch-Onkologische Forschung

Frankfurt am Main, Germany

Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

Frankfurt am Main, Germany

Klinikum Fulda, Klinisches Studienzentrum GmbH

Fulda, Germany

Universitätsklinik der Justus-Liebig-Universität, Medizinische Klinik IV

Giessen, Germany

Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch, Klinik für Hämatologie - Onkologie

Goch, Germany

Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie

Hagen, Germany

Asklepios Klinik Hamburg St. Georg

Hamburg, Germany

Universitätsklinikum Hamburg Eppendorf, Zentrum für Onkologie, Studienzentrale der II. Medizinischen Klinik

Hamburg, Germany

Asklepios Klinik Hamburg Altona, II. Med. Klinik

Hamburg, Germany

Immunologisch-onkologisches MVZ am Siloah Krankenhaus

Hanover, Germany

KRH Klinikum Siloah, Klinik für Hämatologie und Onkologie

Hanover, Germany

Onkologische Schwerpunktpraxis Heidelberg

Heidelberg, Germany

Krankenhaus St. Vincentius der evangelischen Stadtmission Heidelberg, Abt. Hämatologie, Onkologie, Rheumatologie

Heidelberg, Germany

University Hospital Heidelberg, Med. Klinik V

Heidelberg, Germany

SLK Kliniken Heilbronn, Med. Klinik III

Heilbronn, Germany

Marien Hospital Herne

Herne, Germany

Universitätsklinikum des Saarlandes, Innere Medizin I

Homburg (Saar), Germany

Westpfalz-Klinikum GmbH, Klinik für Innere Medizin I

Kaiserslautern, Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

Praxisklinik für Hämatologie und Onkologie

Koblenz, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie am Caritas Krankenhaus

Lebach, Germany

Universitätsklinikum Leipzig AöR, Medizinische Klinik und Poliklinik I-Hämatologie und Zelltherapie, Internistische Onkologie, Hämostaseologie

Leipzig, Germany

Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen am Rhein, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik

Mainz, Germany

III. Medizinische Klinik Hämatologie und Internistische Onkologie

Mannheim, Germany

Mannheimer Onkologie Praxis

Mannheim, Germany

Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

Marburg, Germany

Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin

Minden, Germany

Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

Mönchengladbach, Germany

Universitätsklinikum Münster, Med. Klinik A

Münster, Germany

Klinikum Osnabrück GmbH

Osnabrück, Germany

Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie

Paderborn, Germany

Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

Regensburg, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie, Onkologisches Zentrum

Saarlouis, Germany

Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

Schwäbisch Hall, Germany

ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

Siegburg, Germany

Onkologische Schwerpunktpraxis Speyer

Speyer, Germany

Klinikum Stuttgart, Stuttgart Cancer Center, Tumorzentrum Eva Mayr-Stihl

Stuttgart, Germany

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, Germany

University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II

Tübingen, Germany

Bundeswehrkrankenhaus Ulm, Abteilung Innere Medizin - Hämatologie und internistische Onkologie

Ulm, Germany

Schwarzwald-Baar Klinikum, Innere Medizin II

Villingen-Schwenningen, Germany

Rems-Murr-Kliniken gGmbH

Winnenden, Germany

Clinical Research Directory

Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)