Can a new drug stop smoldering myeloma from becoming active cancer?

NCT ID NCT06183489

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Smoldering Multiple Myeloma smoldering plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • A.O. Papa Giovanni XXIII

    Bergamo, Italy

  • A.O. di Padova

    Padova, Italy

  • A.O.U. Careggi

    Florence, Italy

  • A.O.U. Maggiore della Carità Novara

    Novara, Italy

  • A.O.U. Policlinico S. Martino - Ematologia

    Genova, Italy

  • AOU Consorziale Policlinico di Bari

    Bari, Italy

  • C.H.U. de Nantes

    Nantes, France

  • CHD Vendée

    La Roche-sur-Yon, France

  • CHRU Hôpital Bretonneau

    Tours, France

  • CHU Poitiers - Pôle régional de Cancérologie

    Poitiers, France

  • CHU Saint Eloi Département d'Hématologie Clinique

    Montpellier, France

  • Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Italy

  • Erasmus MC

    Rotterdam, Netherlands

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, Italy

  • Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

    Meldola, Italy

  • Oslo Myeloma Center

    Oslo, 0450, Norway

  • Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara

    Roma, Italy

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

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