Clinical trial • Phase II • Oncology
ELRANATAMAB for Smoldering multiple myeloma | High-risk smoldering multiple myeloma
Phase II trial of ELRANATAMAB for Smoldering multiple myeloma | High-risk smoldering multiple myeloma. open-label. 105 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Smoldering multiple myeloma | High-risk smoldering multiple myeloma
- Trial Stage
- Phase II
- Drug Modality
- Other antibody | Small molecule | Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 11-10-2023
- First CTIS Authorization Date
- 13-02-2024
Trial design
open-label Phase II trial in Greece, Finland, Italy and others.
- Open Label
- Yes
- Target Sample Size
- 105
Eligibility
Recruits 105 No vulnerable populations selected for inclusion. Persons under guardianship/trusteeship or deprived of freedom are explicitly excluded. Consent must be provided by the subject or a legally acceptable representative as stated in the ICF..
- Pregnancy Exclusion
- Female subject who is pregnant or breast-feeding.
- Vulnerable Population
- No vulnerable populations selected for inclusion. Persons under guardianship/trusteeship or deprived of freedom are explicitly excluded. Consent must be provided by the subject or a legally acceptable representative as stated in the ICF.
Inclusion criteria
- {"criterion_text":"- ≥ 18 years of age"}
- {"criterion_text":"- Diagnosis of SMM for ≤5 years with measurable disease, defined as serum M protein: ≥1g/dL or urine M protein ≥200 mg/24 hours or involved serum FLC ≥100 mg/Land abnormal serum FLC ratio."}
- {"criterion_text":"- BMPCs ≥10% and <60%"}
- {"criterion_text":"- Presence of at least 2 high risk factors, including a. Serum M protein ≥2 g/dL, b. BMPC >20% c. Serum involved/uninvolved FLC ratio > 20"}
- {"criterion_text":"- ECOG performance status score of 0 or 1"}
- {"criterion_text":"- Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1) a. Absolute neutrophil count ≥1.0 x 10^9 /L (ie, ≥1000/μL) b. Platelet count ≥75 x 10^9 /L c. Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) d. Alanine aminotransferase (ALT) ≤2.5 x ULN e. Total bilirubin ≤1.5 x ULN, except in subjects with congenital bilirubinemia,such as Gilbert syndrome (in which case direct bilirubin ≤2.0 x ULN is required)"}
- {"criterion_text":"- Subject must sign an informed consent form (ICF) or their legally acceptable representative must sign indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study."}
- {"criterion_text":"- Women of childbearing potential must have a negative serum or urine pregnancy test at screening and before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (One highly effective method and one additional effective method) used at the same time, and continuing for at least 5 months after the last dose of Elranatamab. Women must also agree to notify pregnancy during the study."}
Exclusion criteria
- {"criterion_text":"- Previous therapy with any systemic therapy for multiple myeloma."}
- {"criterion_text":"- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer free of disease for 5 years."}
- {"criterion_text":"- Female subject who is pregnant or breast-feeding."}
- {"criterion_text":"- Serious medical or psychiatric illness likely to interfere with participation in study."}
- {"criterion_text":"- Uncontrolled diabetes mellitus"}
- {"criterion_text":"- Known HIV infection; Known active hepatitis B or C viral infection; known active COVID-19/SARS-CoV-2 infection."}
- {"criterion_text":"- Live attenuated vaccine administered within 4 weeks of the first dose of study intervention."}
- {"criterion_text":"- Ongoing treatment with corticosteroids : dose >10mg prednisone"}
- {"criterion_text":"- Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision."}
- {"criterion_text":"- Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): a. Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL b. Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL c. Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted d. ≥ 1 bone lytic lesion e. BMPCs ≥60% f. Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L g. Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter)"}
- {"criterion_text":"- Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma."}
- {"criterion_text":"- Subject has a diagnosis of Waldenström’s macroglobulinemia, or other conditions in which IgM Mprotein is present in theabsence of a clonal plasma cell infiltration with lytic bone lesions."}
- {"criterion_text":"- Subject has had plasmapheresis within 14 days of C1D1."}
- {"criterion_text":"- Myocardial infarction within 6 months prior to enrolment according to NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities."}
- {"criterion_text":"- Ongoing Grade 2 or higher peripheral sensory/motor peripheral neuropathy (PN), history of GBS or GBS variants, or history of grade 3 or higher peripheral motor polyneuropathy."}
- {"criterion_text":"- Subject has had major surgery within 2 weeks before eligibility confirmation or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study."}
- {"criterion_text":"- Clinically relevant active infection or serious co-morbid medical conditions."}
- {"criterion_text":"- Participants with known or suspected hypersensitivity to the study interventions or any of their excipients"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Complete remission rate at the end of cycle 6, assessed by International Myeloma Working Group [IMWG] criteria.","definition_or_measurement_approach":"Assessed by International Myeloma Working Group (IMWG) criteria"}
- {"endpoint_text":"- Rate of grade >3-4 non hematologic adverse events, assessed according to CTCAE 5.0.","definition_or_measurement_approach":"Assessed according to CTCAE 5.0"}
Recruitment
- Planned Sample Size
- 105
- Recruitment Window Months
- 91
- Consent Approach
- Subjects must sign an informed consent form (ICF) or their legally acceptable representative must sign. Country-specific ICF documents are provided (country-language ICFs available in English, Finnish, Greek, Italian, French, Dutch, Norwegian as per uploaded country ICF documents). Women of childbearing potential must have a negative pregnancy test at screening and before starting study drug and agree to contraception/abstinence conditions and to notify pregnancy.
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 105
Greece
- Latest Decision Or Authorization Date
- 14-08-2025
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Alexandra Hospital
- Department Name
- 04-001:Clinical Therapeutics
- Contact Person Name
- Evangelos Terpos
- Contact Person Email
- eterpos@med.uoa.gr
Finland
- Latest Decision Or Authorization Date
- 13-08-2025
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Helsinki University Central Hospital
- Department Name
- 19-002:Department of hematoligy
- Contact Person Name
- Juha Lievonen
- Contact Person Email
- uha.lievonen@hus.fi
Italy
- Latest Decision Or Authorization Date
- 02-02-2026
- Number Of Sites
- 12
- Number Of Participants
- 36
Sites
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- 01-049:UO Ematologia e Centro Trapianti Midollo Osseo
- Contact Person Name
- Nicola Giuliani
- Contact Person Email
- nicola.giuliani@unipr.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- 01-019:UO EMATOLOGIA CON TRAPIANTO
- Contact Person Name
- Pellegrino Musto
- Contact Person Email
- pellegrino.musto@uniba.it
- Site Name
- Azienda Sanitaria Locale Di Pescara
- Department Name
- 01-053:UOC Ematologia Clinica
- Contact Person Name
- Carmine Liberatore
- Contact Person Email
- Liberatore.carmine@hsr.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- 01-036:Oncologia Medica
- Contact Person Name
- Claudio Cerchione
- Contact Person Email
- claudio.cerchione@irst.emr.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- 01-051:UOC Ematologia
- Contact Person Name
- Silvia Mangiacavalli
- Contact Person Email
- S.Mangiacavalli@smatteo.pv.it
- Site Name
- Careggi University Hospital
- Department Name
- 01-030:SOD Ematologia
- Contact Person Name
- Elisabetta Antonioli
- Contact Person Email
- antoniolie@aou-careggi.toscana.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- 01-010:SCDU Ematologia
- Contact Person Name
- Gloria Margiotta-Casaluci
- Contact Person Email
- gloria.margiotta@med.uniupo.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- 01-007:Ematologia e Terapia Cellulari
- Contact Person Name
- Sara Aquino
- Contact Person Email
- sara.aquino@hsanmartino.it
- Site Name
- Azienda Ospedaliera Papa Giovanni XXIII
- Department Name
- 01-003: Medicina Trasfusionale ed Ematologia
- Contact Person Name
- Monica Galli
- Contact Person Email
- monicagalli@asst-pg23.it
- Site Name
- Azienda Ospedaliera Papardo
- Department Name
- 01-037:UOC Ematologia
- Contact Person Name
- Donato Mannina
- Contact Person Email
- donamanni@gmail.com
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- 01-015:Clinica Ematologica
- Contact Person Name
- Francesca Patriarca
- Contact Person Email
- francesca.patriarca@asufc.sanita.fvg.it
- Site Name
- Azienda Ospedale-Universita Padova
- Department Name
- 01-011:UOC Ematologia
- Contact Person Name
- Renato Zambello
- Contact Person Email
- rani.zambello@gmail.com
Norway
- Latest Decision Or Authorization Date
- 14-06-2024
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- 23-007:Avd Blodsykdommer
- Contact Person Name
- Fredrik Schjesvold
- Contact Person Email
- fredrikschjesvold@gmail.com
France
- Latest Decision Or Authorization Date
- 29-01-2026
- Number Of Sites
- 6
- Number Of Participants
- 33
Sites
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- 12-028 Hématologie et thérapie cellulaire
- Contact Person Name
- Thomas Chalopin
- Contact Person Email
- t.chalopin@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- 12-033 Hématologie Clinique
- Contact Person Name
- Valentine RICHEZ-OLIVIER
- Contact Person Email
- richez-olivier.v@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- 12-022 Hématologie et thérapie cellulaire
- Contact Person Name
- Xavier Leleu
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- University Hospital Of Montpellier
- Department Name
- 12-015 Hématologie clinique
- Contact Person Name
- Laure Vincent
- Contact Person Email
- l-vincent@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- 12-016 Hématologie clinique
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- cyrille.touzeau@chu-nantes.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- 12-032 Onco-hématologie
- Contact Person Name
- Komivi Agbestivi
- Contact Person Email
- komivi.agbetsivi@ght85.fr
Netherlands
- Latest Decision Or Authorization Date
- 13-01-2026
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- University Hospital Maastricht
- Department Name
- 02-037:Hematologie
- Contact Person Name
- Janine van Elssen-Hodenius
- Contact Person Email
- janine.van.elssen@mumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- 02-044:Hematologie
- Contact Person Name
- Annemiek Broijl
- Contact Person Email
- a.broyl@erasmusmc.nl
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- 02-038:Hematologie
- Contact Person Name
- Inger Nijhof
- Contact Person Email
- i.nijhof@antoniusziekenhuis.nl
Sponsor
Primary sponsor
- Full Name
- European Myeloma Network B.V.
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Netherlands
Contract research organisations
- Name
- Excelya Greece CRO Single Member S.A.
- Responsibilities
- Start-Up activities; sponsorDuties codes: [1,15]; contact: clinicalRa-greece@excelya.com
- Name
- PPD Development LP
- Responsibilities
- sponsorDuties codes: [4]; contact: Lindsay.Turnpin@ppd.com
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: [1,11,12,8,9]; contact: Clinicaltrial.Enquiries@parexel.com
Third parties
- {"country":"Italy","full_name":"Emn Trial Office S.r.l. Impresa Sociale","duties_or_roles":"sponsorDuties codes: [4]; contact: torinocentrallab@emn.org","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"sponsorDuties codes: [1, 15]; value for code 15: Start-Up activities; contact: clinicalRa-greece@excelya.com","organisation_type":"Pharmaceutical company / CRO"}
- {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"sponsorDuties codes: [15]; value for code 15: IMP Packaging and labelling; contact: contact@clinigencsm.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [4]; contact: Lindsay.Turnpin@ppd.com","organisation_type":"Pharmaceutical company / CRO"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [1,11,12,8,9]; contact: Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company / CRO"}
- {"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"sponsorDuties codes: [4]; contact: myeloma.hematology@erasmusmc.nl","organisation_type":"Hospital/Clinic/Other health care facility"}
Co-sponsors
- Emn Trial Office S.r.l. Impresa Sociale
Investigational products
- Investigational Product Name
- ELRANATAMAB
- Active Substance
- ELRANATAMAB
- Modality
- Other antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Maximum Dose
- maxDailyDoseAmount 76 mg; maxTotalDoseAmount 2096 mg
- Investigational Product Name
- RoActemra 20 mg/mL concentrate for solution for infusion
- Active Substance
- TOCILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- marketingAuthorisation EU/1/08/492/003 (authorised)
- Maximum Dose
- maxDailyDoseAmount 800 mg; maxTotalDoseAmount 800 mg
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus: 2
- Maximum Dose
- maxDailyDoseAmount 20 mg; maxTotalDoseAmount 60 mg
- Investigational Product Name
- PARACETAMOL
- Active Substance
- PARACETAMOL
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus: 2
- Maximum Dose
- maxDailyDoseAmount 500 mg; maxTotalDoseAmount 1500 mg
- Investigational Product Name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus: 2
- Maximum Dose
- maxDailyDoseAmount 25 mg; maxTotalDoseAmount 75 mg
- Combination Treatment
- Yes
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