Home › Trials › NCT06183489

Elranatamab treatment for high-risk smoldering multiple myeloma

A Multi-center, Open-label, Phase 2 Study of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

Phase 2 Interventional European Myeloma Network B.V. · NCT06183489

This study is testing if a new treatment called Elranatamab can help adults with high-risk smoldering multiple myeloma feel better and stay safe from the disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Myeloma Network B.V. Research network
Drugs / interventionsElranatamab, prednisone
Locations25 sites (Helsinki and 24 other locations)
Trial IDNCT06183489 on ClinicalTrials.gov

What this trial studies

This multicenter, single-arm, open-label Phase 2 study evaluates the efficacy and safety of Elranatamab in patients with previously untreated high-risk smoldering multiple myeloma (SMM). Participants must be over 18 years old and have a diagnosis of SMM for five years or less, with measurable disease and specific high-risk factors. The study aims to provide insights into how well Elranatamab can manage this condition and its safety profile in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a diagnosis of high-risk smoldering multiple myeloma and specific measurable disease criteria.

Not a fit: Patients with low-risk smoldering multiple myeloma or those who have received prior treatment for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-risk smoldering multiple myeloma, potentially delaying progression to active multiple myeloma.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating multiple myeloma with novel therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Helsinki and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Smoldering Multiple Myelomahigh-risk smoldering Multiple MyelomaElranatamab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.