A Phase 2 interventional study of Elranatamab in Smoldering Multiple Myeloma, sponsored by European Myeloma Network B.V.. Active, not recruiting at 18 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by European Myeloma Network B.V. · Phase 2, Interventional, and Treatment
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.
101 studies on the registry are indexed under Smoldering Multiple Myeloma; 33 are open to participants now.
This study's planned enrollment of 50 is above the median of 36 across 72 interventional studies indexed under Smoldering Multiple Myeloma.
Browse Smoldering Multiple Myeloma studies →European Myeloma Network B.V. is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Presence of at least 2 high risk factors, including
Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1)
Exclusion Criteria:
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):
Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle)
Drug: Elranatamab
Elranatamab will be administered via a subcutaneous injection (SC)
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
Time frame: average 24 weeks
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.
Time frame: 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.
Time frame: 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.
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 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.
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)
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.
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)
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
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 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.
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)
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.
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
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.
Time frame: from screening, cycle 1 and every 3 cycles there after up to end of treatment and 28 days after last treatment
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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European Myeloma Network B.V.