Can a new drug stop smoldering myeloma from becoming active cancer?
NCT ID NCT06183489
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether the drug elranatamab can help people with high-risk smoldering multiple myeloma, a condition where abnormal plasma cells are present but have not yet caused active disease. About 50 adults with this condition will receive elranatamab as a subcutaneous injection. Researchers will measure how many participants achieve a complete remission or better during the first six cycles of treatment, and they will also track safety and overall response rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- elranatamab, an investigational drug given as a subcutaneous injection
- What this could lead to
- If it works, elranatamab could delay or prevent progression to active multiple myeloma, potentially offering a treatment option for people with high-risk smoldering disease.
- What could go wrong
- This is an early-phase, single-arm study with only 50 participants, so results may not generalize. Elranatamab can cause side effects like immune reactions and infections, and it is not yet known if it will meaningfully change the course of the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. \>18 years of age 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: 1. Previous therapy with any systemic therapy for multiple myeloma. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A.O. Papa Giovanni XXIII
Bergamo, Italy
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A.O. di Padova
Padova, Italy
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A.O.U. Careggi
Florence, Italy
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A.O.U. Maggiore della Carità Novara
Novara, Italy
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A.O.U. Policlinico S. Martino - Ematologia
Genova, Italy
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AOU Consorziale Policlinico di Bari
Bari, Italy
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C.H.U. de Nantes
Nantes, France
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CHD Vendée
La Roche-sur-Yon, France
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CHRU Hôpital Bretonneau
Tours, France
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CHU Poitiers - Pôle régional de Cancérologie
Poitiers, France
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CHU Saint Eloi Département d'Hématologie Clinique
Montpellier, France
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Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
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Erasmus MC
Rotterdam, Netherlands
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Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy
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Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, Italy
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Oslo Myeloma Center
Oslo, 0450, Norway
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Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara
Roma, Italy
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St. Antonius Ziekenhuis
Nieuwegein, Netherlands
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Other studies related to the condition(s) this trial covers.
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- New italian network aims to catch rare blood disease earlier