A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
CompletedPhase 2Results postedLast updated 10 February 2026
What this trial tests
Phase 2 trial testing Elranatamab in Multiple Myeloma in 86 participants. Completed in 12 December 2025.
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2Primary· Parts 1 and 2: Cycle 1 (28 days)
CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, Grade (G) 1: fever (temperature \>=38 degree Celsius), hypotension and/or hypoxia none; G 2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/ facemask or blow-by; G 3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring
Group
Value
95% CI
All Participants
12
Number of Participants With Dose Limiting Toxicities (DLTs): Part 2ASecondary· Part 2A: 28 days starting from the first 116 or 152 mg dose
Hematological: grade 4 neutropenia lasting \>5 days; febrile neutropenia; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with grade \>=2 bleeding. Non-hematological: grade \>=4 adverse events (AEs); grade 3 CRS (except CRS events: not been maximally treated or improved to grade \<=1 within 48 hours); grade 3 AEs (except: AEs attributed to a CRS event; grade 3 nausea, vomiting and diarrhea that improve to grade \<= 2 within 72 hours after maximal medical management has been initiated, grade 3 fatigue lasting \<1 week; grade 3 AEs that recover to baseli
Group
Value
95% CI
Part 2A: Dose Level 1
1
Part 2A: Dose Level 2
1
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [All Causalities and Treatment Related]: Parts 1 and 2Secondary· Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed below: Results in death, requires inpatient hospitalization or prolongation of existing hospitalization, life-threatening, congenital anomaly/birth defect etc. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received stu
All cause: AE
Group
Value
95% CI
Part 1
33
Part 2A: Dose Level 1
12
Part 2A: Dose Level 2
11
Part 2B
29
All cause: SAE
Group
Value
95% CI
Part 1
23
Part 2A: Dose Level 1
11
Part 2A: Dose Level 2
8
Part 2B
21
Treatment related: AE
Group
Value
95% CI
Part 1
32
Part 2A: Dose Level 1
12
Part 2A: Dose Level 2
11
Part 2B
25
Treatment related: SAE
Group
Value
95% CI
Part 1
17
Part 2A: Dose Level 1
10
Part 2A: Dose Level 2
6
Part 2B
5
Number of Participants With Maximum Grade 3 or 4 and Grade 5 AEs [All Causalities and Treatment Related] Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5: Parts 1 and 2Secondary· Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. AEs were graded according to NCI CTCAE version 5.0 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent
All cause: Grades 3/4
Group
Value
95% CI
Part 1
26
Part 2A: Dose Level 1
9
Part 2A: Dose Level 2
6
Part 2B
20
All cause: Grade 5
Group
Value
95% CI
Part 1
5
Part 2A: Dose Level 1
2
Part 2A: Dose Level 2
4
Part 2B
5
Treatment related: Grades 3/4
Group
Value
95% CI
Part 1
23
Part 2A: Dose Level 1
10
Part 2A: Dose Level 2
9
Part 2B
16
Treatment related: Grade 5
Group
Value
95% CI
Part 1
0
Part 2A: Dose Level 1
0
Part 2A: Dose Level 2
0
Part 2B
0
Number of Participants With Adverse Events of Special Interest (AESI)- CRS and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) [All Causalities and Treatment Related]: Parts 1 and 2Secondary· Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
CRS and ICANS were assessed according to ASTCT criteria. ASTCT for ICANS: Grade 1 \[immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously\]; Grade 2 \[ICE score 3-6, awakens to voice\]; Grade 3 \[ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging\]; Grade 4 \[ICE 0 (unarousable and unable to perform ICE), Unarousable or requires vigorous or repetitive tactile stimu
All cause: CRS
Group
Value
95% CI
Part 1
20
Part 2A: Dose Level 1
10
Part 2A: Dose Level 2
10
Part 2B
14
All cause: ICANS
Group
Value
95% CI
Part 1
1
Part 2A: Dose Level 1
1
Part 2A: Dose Level 2
2
Part 2B
0
Treatment related: CRS
Group
Value
95% CI
Part 1
20
Part 2A: Dose Level 1
10
Part 2A: Dose Level 2
10
Part 2B
13
Treatment related: ICANS
Group
Value
95% CI
Part 1
1
Part 2A: Dose Level 1
1
Part 2A: Dose Level 2
2
Part 2B
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses.
Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07382739 — A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Mye
· Phase 2
· recruiting
NCT07320326 — ASPIRE: A Registry Study Of Chinese Patients With TCE-RRMM Treated By Elranatamab
· not yet recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide
· Phase 1, PHASE2
· recruiting
NCT06581848 — Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
· active not recruiting
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NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
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NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
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NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 10 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05014412.