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    Summary
    EudraCT Number:2022-000996-38
    Sponsor's Protocol Code Number:GMMG-HD8/DSMM-XIX
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2022-000996-38
    A.3Full title of the trial
    A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib and dexamethasone induction therapy with either intravenous or subcutaneous isatuximab in transplant-eligible patients with newly diagnosed multiple myeloma
    Randomisierte Phase 3-Nichtunterlegenheitsstudie zur Untersuchung einer Induktionstherapie mit Lenalidomid, Bortezomib und Dexamethason mit intravenöser oder subkutaner Gabe von Isatuximab für Patienten mit neudiagnostiziertem Multiplen Myelom, die für eine Hochdosis-Chemotherapie mit nachfolgender autologer Stammzelltransplantation geeignet sind
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial in patients with newly diagnosed myeloma to assess non-inferiority of induction therapy with isatuximab/lenalidomide/ bortezomib/ dexamethasone when isatuximab is administered subcutaneously versus intravenously
    Studie für Patienten mit zuvor unbehandeltem Multiplen Myelom zur Untersuchung der Wirksamkeit der Induktionstherapie mit Isatuximab/Lenalidomid/ Bortezomib/ Dexamethason bei Gabe von Isatuximab unter die Haut (subkutan) gegenüber einer Gabe in die Vene (intravenös) als Vergleichsmethode
    A.3.2Name or abbreviated title of the trial where available
    GMMG-HD8/DSMM-XIX
    A.4.1Sponsor's protocol code numberGMMG-HD8/DSMM-XIX
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRuprecht-Karls-Universität Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis Recherche & Developpement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGMMG Study Office
    B.5.2Functional name of contact pointGMMG Studiensekretariat
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 130.3
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)6221-568198
    B.5.5Fax number+49(o)6221-561957
    B.5.6E-mails.gmmg@med.uni-heidelberg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIsatuximab
    D.3.2Product code SAR650984
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.4EV Substance CodeSUB187359
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIsatuximab
    D.3.2Product code SAR650984
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.4EV Substance CodeSUB187359
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed symptomatic multiple myeloma
    Symptomatisches Multiples Myelom, Primärtherapie
    E.1.1.1Medical condition in easily understood language
    Symptomatic, newly diagnosed (previously untreated) multiple myeloma
    Bisher unbehandeltes, symptomatisches Multiples Myelom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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).
    Nachweis der Nicht-Unterlegenheit von subkutaner Isatuximab-Applikation im Vergleich mit intravenöser Isatuximab-Gabe hinsichtlich VGPR-Raten oder besser nach Induktionstherapie (gemäß IMWG Response- Kriterien).
    E.2.2Secondary objectives of the trial
    Key secondary objectives
    (1) Comparison of 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.

    Further secondary objectives
    - Rates of NGS-MRD negativity (sensitivity 10-5, from BMA) independent of standard IMWG response after first HDM/ASCT
    - Rates of MRD negativity by NGF (sensitivity 10-5, from BMA) independent of standard IMWG response2 after induction therapy
    - Rates of NGF-MRD negativity (sensitivity 10-5, from BMA) independent of standard IMWG response2 after first HDM/ASCT
    - Rates of best overall response to treatment (BOR)
    - Progression-free survival (PFS)
    Hauptsächliche sekundäre Ziele:
    •Vergleich der ”Patient-Reported-Outcomes (PRO)” bezüglich der Applikationsmethode von Isatuximab (intravenös vs. subkutan) in der Induktionstherapie
    •Nicht-Unterlegenheit der MRD-Negativität (Sensitivitätsgrenze 10-5) durch Next-Generation- Sequencing (NGS) unabhängig von der Standard-IMWG-Response nach Induktion
    Weitere sekundäre Ziele
    - Raten der NGS-MRD Negativität nach erster HDM/ASCT
    - Raten der MRD-Negativität (NGF) nach Induktionstherapie
    - Raten der MRD-Negativität (NGF) nach erster HDM/ASCT
    - RAten der "best overall response to treatment (BOR)"
    - Progressionsfreies Überleben (PFS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A subgroup of patients (selected trial sites) will be investigated by DWI-MRI and/or PET-CT
    included in the trial protocol
    E.3Principal inclusion criteria
    - Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria according to IMWG)
    - Patient is eligible for HDM (200 mg/m2 melphalan) and ASCT
    - 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
    - Serum FLC assay: involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal
    - Age 18-70 years at trial inclusion
    - WHO performance status 0-2
    - Negative pregnancy test at inclusion in women of childbearing potential
    - For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy
    - All patients must agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy
    - Ability of patient to understand character and individual consequences of the clinical trial
    - Written informed consent (must be available before enrolment in the trial)
    •Bestätigte Diagnose eines neu diagnostizierten behandlungsbedürftigen Multiplen Myeloms (nach überarbeiteten IMWG-Kriterien; Rajkumar et al, 2014, Lancet Oncol.)
    •Patient ist für eine Hochdosis-Chemotherapie und autologe Stammzelltransplantation geeignet
    •Messbare Krankheitsaktivität: Quantifizierbares monoklonales Protein (M-Protein) bestimmt durch mind. eine der folgenden drei Messungen:
    -Serum M-Protein ≥10 g/l (für IgA ≥5 g/l) oder
    -Urin Bence-Jones-Protein (M-Protein) ≥200 mg/24h oder
    -Konzentration der betroffenen freien Leichtkette im Serum (sFLC) ≥10 mg/dl und abnorme sFLC-Ratio
    •Alter: 18 bis einschließlich 70 Jahre
    •WHO Performance Status 0-2
    •Ausreichende Leber-, Nieren-, Knochenmark- und Herzfunktion (Ausschluss klinisch relevanter Einschränkungen)
    •Negativer Schwangerschaftstest bei Einschluss (gebärfähige Frauen)
    •Einverständnis der Patienten, die regulatorischen Anforderungen zur Schwangerschaftsverhütung bei Lenalidomid-Einnahme einzuhalten
    •Schriftlich erklärte Einwilligung
    E.4Principal exclusion criteria
    - Systemic AL amyloidosis
    - Plasma cell leukemia
    - Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression.
    - Severe cardiac dysfunction
    - Significant hepatic dysfunction
    - 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
    - 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.
    -systemische AL-Amyloidose
    -Plasmazell-Leukämie
    -vorherige Chemotherapie oder Radiotherapie während der letzen 5 Jahre (außer lokaler Strahlentherapie im Fall eines lokalen Fortschreitens des Myeloms)
    -schwere Einschränkung der Herzfunktion
    -signifikante Einschränkung der Leberfunktion
    -HIV Positivität
    -aktiven, unkontrollierte Infektionen
    -schwere Niereninsuffizienz oder Hämodialyse
    -Periphere Neuropathie oder neuropathischer Schmerz (ab Grad 2)
    -vorangegangene maligne Erkrankung in den letzten 5 Jahren mit Ausnahme der folgenden Krebserkrankungen nach kurativer Therapie: Basalzellkarzinom der Haut, Plattenepithelkarzinom der Haut, Cervix-Karzinom Stadium 0 oder jegliches "In-situ-Malignom"
    E.5 End points
    E.5.1Primary end point(s)
    Rates of VGPR or better (according to standard IMWG response criteria), defined as proportion of patients with at least VGPR after induction therapy
    Rate an VGPR oder besser (gemäß IMWG Response-Kriterien)
    E.5.1.1Timepoint(s) of evaluation of this end point
    after induction therapy
    Nach Induktionstherapie.
    E.5.2Secondary end point(s)
    Key secondary endpoints
    (1) PRO outcomes score assessed by CTSQ (subdomain “satisfaction with therapy”) for SC vs. IV isatuximab application on induction therapy
    (2) Rates of NGS-MRD negativity (sensitivity 10-5, from BMA) after induction therapy
    Hauptsächliche sekundäre Endpunkte
    (1)"Patient reported outcome" ausgewertet nach "CTSQ" (Unterpunkt "Zufriedenheit mit der Therapie") im Hinblick auf die subkutane gegenüber der intravenösen Applikation von Isatuximab während der Induktionstherapie
    (2)Rate der MRD-Negativität (mittels NGS, Sensitivität von 10^-5, bestimmt an Knochenmarkaspirat) nach der Induktionstherapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    after induction therapy
    nach Induktionstherapie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient reported outcome, quality of life
    Vergleich der ”Patient-Reported-Outcomes (PRO)”, Lebensqualität
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned93
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    clinical end of the trial: LVLS
    overall end of the trial: at completion of trial report
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 412
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state450
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 514
    F.4.2.2In the whole clinical trial 514
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    See Chapter 9.1.1 of the trial protocol
    After regular EOS, i.e. after first HDM/ASCT patients may receive further consolidation (e.g. second HDM/ASCT) and/or maintenance treatment according to local practice and current recommendations for the treatment of patients with newly-diagnosed MM, accounting for patient´s individual disease and patient-specific characteristics.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Universitätsklinikum Würzburg, Med. Klinik und Poliklinik II, and DSMM study group
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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