Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
NCT ID: NCT06183489
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2024-05-14
2031-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Elranatamab
Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle)
Elranatamab
Elranatamab will be administered via a subcutaneous injection (SC)
Interventions
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Elranatamab
Elranatamab will be administered via a subcutaneous injection (SC)
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. BMPCs ≥10% and \<60%
4. Presence of at least 2 high risk factors, including
1. Serum M protein ≥2 g/dL,
2. BMPC \>20%
3. Serum involved/uninvolved FLC ratio \> 20
5. ECOG performance status score of 0 or 1
6. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1)
1. Absolute neutrophil count ≥1.0 x 109/L (ie, ≥1000/μL)
2. Platelet count ≥75 x 109/L
3. Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN)
4. Alanine aminotransferase (ALT) ≤2.5 x ULN
5. 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)
7. 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.
8. 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
2. 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):
1. Increased calcium levels: Corrected serum calcium \>1 mg/dL above the ULN or \>11 mg/dL
2. 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
3. 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
4. ≥ 1 bone lytic lesion
5. BMPCs ≥60%
6. Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L
7. 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)
3. Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma.
4. Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
5. Subject has had plasmapheresis within 14 days of elegibility confirmation.
6. 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
7. 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
8. Subject has had major surgery within 2 weeks before elegibility 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.
9. Clinically relevant active infection or serious co-morbid medical conditions
10. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer free of disease since 5 years.
11. Female subject who is pregnant or breast-feeding
12. Serious medical or psychiatric illness likely to interfere with participation in study
13. Uncontrolled diabetes mellitus
14. Known HIV infection; Known active hepatitis B or C viral infection; known active COVID-19/SARS-CoV-2 infection
15. Live attenuated vaccine administered within 4 weeks of the first dose of study intervention
16. Ongoing treatment with corticosteroids : dose \>10mg prednisone etc.
17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Stichting European Myeloma Network
NETWORK
Responsible Party
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Locations
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Helsinki University Hospital
Helsinki, , Finland
CHD Vendée
La Roche-sur-Yon, , France
CHRU de Lille - Hopital Claude Huriez
Lille, , France
CHU Saint Eloi Département d'Hématologie Clinique
Montpellier, , France
CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE
Nantes, , France
CHU NICE - Hôpital Archet
Nice, , France
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, , France
CHRU Hôpital Bretonneau
Tours, , France
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens, , Greece
AOU Consorziale Policlinico di Bari
Bari, , Italy
A.O. Papa Giovanni XXIII
Bergamo, , Italy
A.O.U. Careggi
Florence, , Italy
A.O.U. Policlinico S. Martino - Ematologia
Genova, , Italy
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, , Italy
Ospedale Papardo
Messina, , Italy
A.O.U. Maggiore della Carità Novara
Novara, , Italy
A.O. di Padova
Padua, , Italy
A.O.U. di Parma - U.O Ematologia e CTMO
Parma, , Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, , Italy
Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara
Roma, , Italy
Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale
Udine, , Italy
Maastricht UMC
Maastricht, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Oslo Myeloma Center
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Lievonen
Role: primary
Tiab
Role: primary
Manier
Role: primary
Vincent
Role: primary
Cyrille TOUZEAU, MD
Role: primary
Richez - Olivier
Role: primary
Leleu
Role: primary
Chalopin
Role: primary
Evangelos Terpos
Role: primary
Pellegrino Musto, Prof.
Role: primary
Rambaldi
Role: primary
Antonioli
Role: primary
Aquino
Role: primary
Cerchione
Role: primary
Mannina
Role: primary
Margiotta Casaluci
Role: primary
Zambello
Role: primary
Giuliani
Role: primary
Mangiacavalli
Role: primary
Liberatore
Role: primary
Patriarca
Role: primary
van Elsen
Role: primary
Nijhoff
Role: primary
Broijl
Role: primary
Friedrik Schjesvold
Role: primary
Other Identifiers
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EMN34/2023-505775-70-00
Identifier Type: -
Identifier Source: org_study_id
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