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New treatment option for Smoldering Multiple Myeloma
Official title Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
ClinicalTrials.gov ID: NCT06183489
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for smoldering multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \>18 years of age
- 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...
- BMPCs ≥10% and \<60%
- Presence of at least 2 high risk factors, including
- Serum M protein ≥2 g/dL,
You likely can't join if
- Previous therapy with any systemic therapy for multiple myeloma.
- Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below...
- Increased calcium levels: Corrected serum calcium \>1 mg/dL above the ULN or \>11 mg/dL
- Renal insufficiency: Determined by glomerular filtration rate (GFR) \ 2 mg/dL
- Anemia (hemoglobin 2 g/dL below lower limit of normal or \<10 g/dL or both) transfusion support or concurrent treatment with erythropoietin...
- ≥ 1 bone lytic lesion
See the full eligibility criteria
- \>18 years of age
- 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.
- BMPCs ≥10% and \<60%
- Presence of at least 2 high risk factors, including
- Serum M protein ≥2 g/dL,
- BMPC \>20%
- Serum involved/uninvolved FLC ratio \> 20
- ECOG performance status score of 0 or 1
- people must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1)
- Absolute neutrophil count ≥1.0 x 109/L (ie, ≥1000/μL)
- Platelet count ≥75 x 109/L
- Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤2.5 x ULN
- Total bilirubin ≤1.5 x ULN, except in people with congenital bilirubinemia,such as Gilbert syndrome (in which case direct bilirubin ≤2.0 x ULN is required)
- 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...
- 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...
- Previous therapy with any systemic therapy for multiple myeloma.
- 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):
- Increased calcium levels: Corrected serum calcium \>1 mg/dL above the ULN or \>11 mg/dL
- Renal insufficiency: Determined by glomerular filtration rate (GFR) \ 2 mg/dL
- 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
- ≥ 1 bone lytic lesion
- BMPCs ≥60%
- Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L
- 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)
- Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma.
- 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.
- Subject has had plasmapheresis within 14 days of elegibility confirmation.
- 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...
- 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
- 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.
- Clinically relevant active infection or serious co-morbid medical conditions
- 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.
- Female subject who is pregnant or breast-feeding
- Serious medical or psychiatric illness likely to interfere with participation in study
- Uncontrolled diabetes mellitus
- Known HIV infection; Known active hepatitis B or C viral infection; known active COVID-19/SARS-CoV-2 infection
- Live attenuated vaccine administered within 4 weeks of the first dose of study intervention
- Ongoing treatment with corticosteroids : dose \>10mg prednisone etc.
- Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- La Roche-sur-Yon, France
- Lille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Poitiers, France
- Tours, France
- Athens, Greece
- Bari, Italy
- Bergamo, Italy
- Florence, Italy
- Genova, Italy
- Meldola, Italy
- Messina, Italy
- Novara, Italy
- Padova, Italy
- Parma, Italy
- Pavia, Italy
- Roma, Italy
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; La Roche-sur-Yon, France; Lille, France; Montpellier, France; Nantes, France; Nice, France and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.