Actively Recruiting
Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
Led by Stichting European Myeloma Network · Updated on 2024-10-18
50
Participants Needed
25
Research Sites
372 weeks
Total Duration
On this page
Sponsors
S
Stichting European Myeloma Network
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.
CONDITIONS
Official Title
Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Diagnosed with smoldering multiple myeloma for 5 years or less with measurable disease defined as serum M protein of at least 1 g/dL, urine M protein at least 200 mg/24 hours, or involved serum free light chain (FLC) 100 mg/L or greater with abnormal serum FLC ratio
- Bone marrow plasma cells (BMPCs) between 10% and less than 60%
- Presence of at least two high-risk factors: serum M protein 2 g/dL or more, BMPC more than 20%, or serum involved/uninvolved FLC ratio greater than 20
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Meet specific laboratory parameters within 15 days before starting treatment, including absolute neutrophil count 1.0 x 10^9/L or higher, platelet count 75 x 10^9/L or higher, AST and ALT less than or equal to 2.5 times the upper limit of normal, total bilirubin less than or equal to 1.5 times the upper limit of normal (with exceptions for congenital bilirubinemia)
- Signed informed consent form
- Women of childbearing potential must have a negative pregnancy test at screening and before starting study drug and agree to use two acceptable methods of birth control during and for 5 months after treatment
You will not qualify if you...
- Previous systemic therapy for multiple myeloma
- Evidence of calcium, renal failure, anemia, bone lesions, or myeloma defining events related to smoldering multiple myeloma
- Corrected serum calcium more than 1 mg/dL above upper limit of normal or over 11 mg/dL
- Renal insufficiency with GFR less than 40 mL/min/1.73 m² or serum creatinine over 2 mg/dL
- Anemia with hemoglobin 2 g/dL below normal or less than 10 g/dL
- One or more bone lytic lesions
- Bone marrow plasma cells 60% or more
- Serum involved/uninvolved FLC ratio 100 or more with involved FLC 100 mg/L or greater
- More than one bone focal lesion greater than or equal to 5 mm on whole body MRI or PET-CT
- Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma
- Diagnosis of Waldenström's macroglobulinemia or conditions with IgM M-protein without clonal plasma cell infiltration with bone lesions
- Plasmapheresis within 14 days of eligibility confirmation
- Recent myocardial infarction, severe heart failure, uncontrolled angina, serious arrhythmias, or active ischemia
- Ongoing grade 2 or higher peripheral neuropathy, history of Guillain-Barré syndrome or severe polyneuropathy
- Major surgery within 2 weeks before eligibility or planned surgery during study participation
- Active infection or serious comorbid conditions
- Prior malignancies except certain treated cancers free for 5 years
- Pregnancy or breastfeeding
- Serious medical or psychiatric illness interfering with participation
- Uncontrolled diabetes mellitus
- Known HIV, active hepatitis B or C, or active COVID-19 infection
- Live attenuated vaccine within 4 weeks before first dose
- Ongoing corticosteroid treatment over 10 mg prednisone equivalent
- Under legal guardianship or deprived of freedom by judicial decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Helsinki University Hospital
Helsinki, Finland
Not Yet Recruiting
2
CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
3
CHRU de Lille - Hopital Claude Huriez
Lille, France
Not Yet Recruiting
4
CHU Saint Eloi Département d'Hématologie Clinique
Montpellier, France
Actively Recruiting
5
CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE
Nantes, France
Actively Recruiting
6
CHU NICE - Hôpital Archet
Nice, France
Actively Recruiting
7
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, France
Actively Recruiting
8
CHRU Hôpital Bretonneau
Tours, France
Actively Recruiting
9
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens, Greece
Actively Recruiting
10
AOU Consorziale Policlinico di Bari
Bari, Italy
Not Yet Recruiting
11
A.O. Papa Giovanni XXIII
Bergamo, Italy
Actively Recruiting
12
A.O.U. Careggi
Florence, Italy
Actively Recruiting
13
A.O.U. Policlinico S. Martino - Ematologia
Genova, Italy
Not Yet Recruiting
14
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, Italy
Actively Recruiting
15
Ospedale Papardo
Messina, Italy
Actively Recruiting
16
A.O.U. Maggiore della Carità Novara
Novara, Italy
Actively Recruiting
17
A.O. di Padova
Padova, Italy
Not Yet Recruiting
18
A.O.U. di Parma - U.O Ematologia e CTMO
Parma, Italy
Not Yet Recruiting
19
Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy
Not Yet Recruiting
20
Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara
Roma, Italy
Actively Recruiting
21
Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Actively Recruiting
22
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
23
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Actively Recruiting
24
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
25
Oslo Myeloma Center
Oslo, Norway, 0450
Actively Recruiting
Research Team
S
Silvia Villa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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