Trial · NCT05090566
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
NCT05090566, Phase 2, Terminated, Pfizer; results first posted 2026-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma. Trials, record NCT05090566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05090566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
- NCT number
- NCT05090566
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Multiple Myeloma
- Interventions
- Elranatamab + Nirogacestat, Elranatamab + lenalidomide + dexamethasone
- First posted
- 2021-10-25
- Last updated
- 2026-04-24
- Other registries' IDs
- eudract:2021-003885-11
- Results first posted
- 2026-02-23
- Limitations and caveats
- Phase 2 of SSA was not conducted, based on sponsor's decision.
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days) | DLT- Hematological:Grade (G)4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia, infection; G4 thrombocytopenia; G3 thrombocytopenia and G\>=2 bleeding. Non-hematological: G\>=4 adverse events(AEs); G3 cytokine release syndrome(CRS) \[except CRS not been maximally treated or improved to G\<=1 in 48 hours\]; G3 AEs (except AEs attributed to CRS, G3 nausea, vomiting, diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G3-4 laboratory abnormalities(except not associated with clinical sequelae and improve to G=\<2 in 72 hours); G2 clinically important/persistent AEs(cause significant dose delay/reduction) may be DLT; G3 injection site reaction, allergic reaction, anaphylaxis. Common Terminology Criteria for Adverse Events(CTCAE) version 5.0: G1:mild AE, G2:moderate, G3:severe, G4:life-threatening consequences; urgent intervention indicated, G5:death related to AE. |
| Primary | SSB: Number of Participants With DLTs- Phase 1b | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days) | Hematological: G4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia with infection; G4 thrombocytopenia; G3 thrombocytopenia with G\>=2 bleeding. Non-hematological: G\>=4 AEs; G3 CRS (except CRS events: not been maximally treated or improved to grade \<=1 within 48 hours); G3 AEs (except: AEs attributed to CRS, G3 nausea, vomiting and diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G 3-4 laboratory abnormalities (except: not associated with clinical sequelae and improve to G=\<2 within 72 hours); Other clinically important/persistent AEs (that cause significant dose delay/reduction) may be DLT; G3 injection site reaction. CTCAE version 5.0: G1: Mild AE, G2: Moderate, G3: Severe, G4: Life-threatening consequences; urgent intervention indicated, G5: Death related to AE. |
| Secondary | SSA: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs- Phase 1b | From treatment initiation till study completion | An adverse event was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention, including both serious and all non-serious adverse events. A serious adverse event (SAE): any untoward medical occurrence that, at any dose resulting in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. Relatedness of any AE to treatment to be judged by investigator. |
| Secondary | SSA: Number of Participants With Severity of AEs According to Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Grading Criteria 2019- Phase 1b | From treatment initiation till study completion | 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, G1: fever (temperature \>=38 degree Celsius), hypotension and/or hypoxia none; G2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/facemask or blow-by; G3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/facemask, nonrebreather mask, or Venturi mask; G4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G1: mild, G2: moderate, G3: severe, G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. |
| Secondary | SSA: Number of Participants With Severity of AEs According to Immune Effector Cell-associated Neurotoxicity Syndrome ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b | From treatment initiation till study completion | ASTCT for ICANS \[immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition). G1: ICE score 7-9, awakens spontaneously; G2: ICE score 3-6, awakens to voice; G3: ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on electroencephalography that resolve with intervention, focal/local oedema on neuroimaging; G4: ICE score 0 (unarousable and unable to perform ICE), unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, life-threatening prolonged seizure (\>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad; G5: death. |
| Secondary | SSA: Number of Participants With Laboratory Abnormalities- Phase 1b | From treatment initiation till study completion | Number of participants with laboratory abnormalities will be reported in this outcome measure. |
| Secondary | SSA: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | ORR: % of participants with objective response. Stringent complete response(sCR): CR \& normal serum free light chain (sFLC) ratio \&absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum \&urine, disappearance of soft tissue plasmacytomas \&\<5% plasma cells in BMA. If disease measurable by sFLC only, preceding criteria \&normal sFLC ratio. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100 mg/24h; PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M-protein by \>=90% or to \<200 mg/24 hours (If disease measurable by sFLC only: VGPR \& PR: \>=90% \&\>=50% decrease in difference respectively between involved \& uninvolved sFLC levels). In addition, if present at baseline, VGPR \& PR: \>=90% \&\>=50% reduction compared with baseline in soft tissue plasmacytomas' size. |
| Secondary | SSA: Complete Response Rate (CRR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | CRR was defined as the percentage of participants with a Best Overall Response (BOR) of confirmed sCR/CR per IMWG response criteria as determined by investigator. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio \<=4:1 or \>=1:2 for κ and λ participants, respectively, after counting \>=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio \<=4:1 or \>=1:2 for κ and λ participants, respectively, after counting \>=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). |
| Secondary | SSA: Time to Response (TTR) as Per IMWG Criteria as Determined by Investigator-Phase 1b | From treatment initiation till study completion | TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed. |
| Secondary | SSA: Duration of Response (DOR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | DOR (for participants (pts) with objective response (OR) per IMWG)=time from the first OR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) \>=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc \>=0.5 g/dL) (b)Serum M-protein inc \>=1 g/dL if lowest M component \>=5 g/dL (c)Urine M-protein (abs inc \>=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc \>10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc \>=10%) (ii)appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>= 50% inc in longest diameter of a prior lesion \>1 cm in short axis (iii)\>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days) | DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each investigational product (IP) were not evaluable for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | SSB: Number of Participants With DLTs- Phase 1b | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days) | DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each IP were not evaluable for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | SSA: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Severity of AEs According to Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Grading Criteria 2019- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Severity of AEs According to Immune Effector Cell-associated Neurotoxicity Syndrome ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Laboratory Abnormalities- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Complete Response Rate (CRR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Time to Response (TTR) as Per IMWG Criteria as Determined by Investigator-Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Duration of Response (DOR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | 0 | Participants | ||
| SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | 0 | Participants | ||
| SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3 | 4 | Participants | ||
| SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | 0 | Participants | ||
| SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A | 2 | Participants | ||
| SSB: Number of Participants With DLTs- Phase 1b | SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | 3 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | 2 | |
| Overall Study | STARTED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | 6 | |
| Overall Study | STARTED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3 | 10 | |
| Overall Study | STARTED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | 10 | |
| Overall Study | STARTED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A | 6 | |
| Overall Study | STARTED | SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | 12 | |
| Overall Study | COMPLETED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | 0 | |
| Overall Study | COMPLETED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | 0 | |
| Overall Study | COMPLETED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3 | 0 | |
| Overall Study | COMPLETED | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,645
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | 3 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3 | 5 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | 4 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A | 4 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | 8 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | All Participants | 24 | 46 | |
| other | Leukopenia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | 0 | 2 | |
| other | Leukopenia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3 | 1 | 10 |
1 to 10 of 1,645Source ClinicalTrials.gov
See all 1,645 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | 1 | 2 |
| Total, all-cause mortality | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | 3 | 6 |
| Total, all-cause mortality | SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3 | 3 | 10 |
| Total, all-cause mortality | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | 2 | 10 |
| Total, all-cause mortality | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A | 1 | 6 |
| Total, all-cause mortality | SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | 5 | 12 |
| Total, all-cause mortality | All Participants | 15 | 46 |
| Total, other adverse events | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | 2 | 2 |
| Total, other adverse events | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | 6 | 6 |
| Total, other adverse events | SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3 | 10 | 10 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT05090566/registered?page=2