Smoldering Multiple MyelomaPhase 2ERASMMNCT06183489
Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
A Phase 2 study testing Elranatamab in people with Smoldering Multiple Myeloma, run by European Myeloma Network B.V. at 18 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Multiple Myeloma
- What is being tested?
- Elranatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 14 May 2024to Jul 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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,
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- BMPC >20%
- Serum involved/uninvolved FLC ratio > 20
- ECOG performance status score of 0 or 1
- Subjects 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 subjects 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 participate in the study.
- 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.
Who cannot join
- 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) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >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
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- 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 ischemia or active conduction system abnormalities
- 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
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Italy10 sites
AOU Consorziale Policlinico di Bari
Bari
A.O. Papa Giovanni XXIII
Bergamo
A.O.U. Careggi
Florence
A.O.U. Policlinico S. Martino - Ematologia
Genova
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola
A.O.U. Maggiore della Carità Novara
Novara
A.O. di Padova
Padova
Fondazione IRCCS Policlinico S. Matteo
Pavia
Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara
Roma
Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale
Udine
France5 sites
CHD Vendée
La Roche-sur-Yon
CHU Saint Eloi Département d'Hématologie Clinique
Montpellier
C.H.U. de Nantes
Nantes
CHU Poitiers - Pôle régional de Cancérologie
Poitiers
CHRU Hôpital Bretonneau
Tours
About this study
Official title: A Multi-center, Open-label, Phase 2 Study of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
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
- Smoldering Multiple Myeloma
- Being tested
- Elranatamab
- Keywords
- high-risk smoldering Multiple Myeloma, Elranatamab
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElranatamabDrug
Elranatamab will be administered via a subcutaneous injection (SC)
| Study group | Role | What they receive |
|---|---|---|
| Elranatamab | Experimental | Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle) Receives: Drug: Elranatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR) rate
Response of CR is defined as participants who achieve a CR or better (CR+sCR) according to IMWG response criteria, during the first 6 cycles of treatment and before a possible early termination of the treatment
Measured: average 24 weeks
Secondary outcomes (9)
Overall response rate (ORR)
Overall response rate (ORR) is defined as the proportion of participants achieving a confirmed PR or better according to the IMWG response criteria.
Measured: average 24 weeks
MRD-negative CR (MRD_CR)
MRD-negative CR (MRD_CR) is defined as the proportion of participants achieving a MRD negativity (at or below the threshold of 10-5 by NGS) and CR or better according to the IMWG response criteria.
Measured: average 24 weeks
Progression-free survival (PFS)
defined as the time from the date of 1st dose of study drug to the date of first confirmed PD, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first. If the participant is alive and w/o progression disease, the participant's data will be censored at the date of last disease assessment.
Measured: time from the date of 1st dose to to the date of disease progression or death, assed up to 4 years after last dose
Time to progression (TTP)
Time to progression (TTP) is defined as the time from the date of 1st dose of study drug to the date of first documented PD, as defined in the IMWG response criteria. If the participant is w/o progression disease or die, the participant's data will be censored at the date of last disease assessment.
Measured: time from the date of 1st dose to progression or death, assed up to 4 years after last dose
Progression free survival 2 (PFS2)
Progression free survival 2 (PFS2) is defined as the time from the date of 1st dose of study drug to the date of event, which is defined as death from any cause or PD as assessed by investigator that starts after the next line of therapy, whichever occurs first. If the participant starts next line of subsequent therapy without disease progression on study treatment, participant's data will be censored at the last disease assessment before starting next line of therapy. If participant starts next line of therapy after progression on study treatment and is still alive and not yet progress on next line of therapy, participant's data will be censored on the last date of follow-up.
Measured: time from the date of 1st dose to progression on the next line of treatment or death,assed up to 4 years after last dose
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of 1st dose of study drug to the date of death. If the participant is alive, the participant's data will be censored at the date the participant was last known to be alive
Measured: time from the date of 1st dose to date of death, assed up to 4 years after last dose
Time to response (TTR)
Time to response (TTR) is defined as the time from the date of 1st dose of study drug to the first documented response (≥PR). If the participant is alive, w/o progression disease and w/o documented response (≥PR), the participant's data will be censored at the date of last disease assessment. If the participant have a progression or die before a documented response (≥PR), the participant's data will have a competing event at the date of PFS event.
Measured: time frrom the date of 1st dose to the first documented response
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30)
The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-ofLife (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.
Measured: from screening, cycle 1 and every 3 cycles there after up to end of treatment and 28 days after last treatment
Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score
The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in subjects with MY. The module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment,Future Perspective, and Body Image. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Measured: from screening, cycle 1 and every 3 cycles there after up to end of treatment and 28 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start14 May 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoldering Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Myeloma Network B.V.
- Sponsor type
- Research network
- Collaborators
- Pfizer, EMN Trial Office S.r.l. Impresa Sociale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183489
- Sponsor's protocol ID
- EMN34/2023-505775-70-00
- Acronym
- ERASMM
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Phase 2 Study of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06183489
- Acronym / sponsor ID
- ERASMM / EMN34/2023-505775-70-00
- Conditions
- Smoldering Multiple Myeloma
- Keywords
- high-risk smoldering Multiple Myeloma, Elranatamab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- European Myeloma Network B.V.Research network
- Collaborators
- Pfizer, EMN Trial Office S.r.l. Impresa Sociale
- Study start
- 14 May 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elranatamab | Experimental | Drug: ElranatamabParticipant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- >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
Key exclusion criteria (24 listed)
- 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):
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElranatamabElranatamab will be administered via a subcutaneous injection (SC) | Drug | Elranatamab |
Primary outcome
Complete Remission (CR) rate
Time frame: average 24 weeks
Response of CR is defined as participants who achieve a CR or better (CR+sCR) according to IMWG response criteria, during the first 6 cycles of treatment and before a possible early termination of the treatment
9 secondary outcomes
Overall response rate (ORR)
Time frame: average 24 weeks
MRD-negative CR (MRD_CR)
Time frame: average 24 weeks
Progression-free survival (PFS)
Time frame: time from the date of 1st dose to to the date of disease progression or death, assed up to 4 years after last dose
Time to progression (TTP)
Time frame: time from the date of 1st dose to progression or death, assed up to 4 years after last dose
Progression free survival 2 (PFS2)
Time frame: time from the date of 1st dose to progression on the next line of treatment or death,assed up to 4 years after last dose
Overall survival (OS)
Time frame: time from the date of 1st dose to date of death, assed up to 4 years after last dose
Time to response (TTR)
Time frame: time frrom the date of 1st dose to the first documented response
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30)
Time frame: from screening, cycle 1 and every 3 cycles there after up to end of treatment and 28 days after last treatment
Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score
Time frame: from screening, cycle 1 and every 3 cycles there after up to end of treatment and 28 days after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elranatamab in people with Smoldering Multiple Myeloma, run by European Myeloma Network B.V. at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, France, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission (CR) rate (time frame: average 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.