Recent Updates
Recently added Catalysts

Elranatamab

Phase 3

Multiple Myeloma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials9
Total Enrollment3,926
FDA Designations
No designations recorded
Clinical Trials (9)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06152575MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)PHASE3 RECRUITING 492Feb 8, 2024Dec 30, 2027Jun 5, 2026271 United States, Argentina +25
NCT05623020A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for TransplantPHASE3 RECRUITING 1,116Nov 10, 2022Oct 3, 2033May 14, 202689 Australia, Canada +14
NCT05317416Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After TransplantPHASE3 ACTIVE NOT_RECRUITING 854Mar 25, 2022Oct 31, 2029Apr 16, 2026209 United States, Australia +25
NCT05020236A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other TreatmentsPHASE3 RECRUITING 944Oct 4, 2021May 31, 2027May 5, 202690 United States, Argentina +20
NCT05014412A 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 TreatmentPHASE2 COMPLETED 86Oct 7, 2021Dec 12, 2025Feb 10, 202650 United States, Japan +2
NCT04649359MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAbPHASE2 ACTIVE NOT_RECRUITING 187Feb 2, 2021Dec 31, 2026May 19, 202640 United States, Australia +6
NCT06215118A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)PHASE1 RECRUITING 87Feb 20, 2024Mar 9, 2028May 22, 202643 United States, Australia +1
NCT05675449A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple MyelomaPHASE1 ACTIVE NOT_RECRUITING 59Dec 14, 2022Feb 29, 2028Apr 13, 202636 United States, Israel
NCT03269136PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple MyelomaPHASE1 COMPLETED 101Nov 29, 2017Jan 19, 2024Mar 18, 202537 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Progression free survival per International Myeloma Working Group criteria
Up to approximately 5 years

From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first

Part 1 Dose Limiting Toxicity
From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
Part 2: Progression free survival per IMWG
From randomization up to 97 months.
Part 2: Minimal Residual Disease negative CR rate
At 12 months after randomization
Progression Free Survival
Assessed for up to approximately 5 years

Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

Part 1 Safety Lead-In: Incidence of dose limiting toxicities
First 42 days after first elranatamab dose
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Part 3: Frequency of treatment-emergent adverse events
First 84 days after first elranatamab dose
Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2
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 high-flow nasal cannula/ facemask, nonrebreather mask, or Venturi mask; G 4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G 1: Mild, G 2: Moderate, G 3: severe, and G 4: life-threatening consequences; urgent intervention indicated. G 5: death related to AE.

Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)

ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.

Part 1: Number of participants with dose limiting toxicity (DLT)
Cycle 1, about 28 days

Dose limiting toxicity rate based on dose limiting toxicity evaluable participants

Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
Assessed from baseline up to 90 days after last dose of study treatment

Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.

Part 1 Number of participants with dose limiting toxicity (DLT)
From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days.

Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.

Part 2A Number of participants with dose limiting toxicity
From the first dose of maplirpacept through the first cycle of combination treatment, about 64 days.

Dose limiting toxicity based on dose limiting toxicity evaluable participants.

Part 2B Number of participants with dose limiting Toxicity
From first dose of elranatamab through the first cycle of combination treatment, about 42 days.

Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.

Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03
Cycle 1 (21 Days)

Hematological: Grade 4 neutropenia lasting \>5 days; Febrile neutropenia \<1000/mm\^3 with a single temperature of \>38.3 degree Celsius (C) or a sustained temperature of \>=38 degree C for more than one hour; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with \>= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting \>=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to \<=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.

Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)

ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by \>=90% or to \<200 mg/24 hr. If serum and urine M-protein were unmeasurable, \>=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.

Part 2: Duration of Response (DOR) as Per IMWG Criteria
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 34.3 months)

DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum \& urine \& disappearance of any soft tissue plasmacytomas\&\<5% plasma cells in bone marrow aspirates.VGPR: serum \& urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.

Secondary Endpoints
Overall survival
Up to approximately 5 years
Progression free survival on next-line treatment per International Myeloma Working Group criteria
Up to approximately 5 years
Objective response rate per International Myeloma Working Group criteria
Up to approximately 5 years
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ElranatamabEXPERIMENTALParticipants will receive elranatamab monotherapy
Investigator's ChoiceACTIVE_COMPARATORParticipants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
Part 1, Dose Level 1: Elranatamab + Daratumumab + LenalidomideEXPERIMENTAL -
Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + LenalidomideEXPERIMENTAL -
Part 2 Randomized Arm A: Elranatamab + Daratumumab + LenalidomideEXPERIMENTAL -
Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + DexamethasoneACTIVE_COMPARATOR -
Part 1: Elranatamab + LenalidomideEXPERIMENTAL -
Arm A - Part 1EXPERIMENTALElranatamab
Arm B - Part 1ACTIVE_COMPARATORLenalidomide
Arm B - Part 2ACTIVE_COMPARATORLenalidomide
Arm C - Part 2EXPERIMENTALElranatamab
Part 1 Safety Lead-In Dose Escalation: Elranatamab + DaratumumabEXPERIMENTAL -
Part 2 Randomized Arm A: ElranatamabEXPERIMENTAL -
Part 2 Randomized Arm B: Elranatamab + DaratumumabEXPERIMENTAL -
Part 2 Randomized Arm C: Daratumumab + Pomalidomide + DexamethasoneACTIVE_COMPARATOR -
Part 3 Arm D: ElranatamabEXPERIMENTAL -
Part 3 Arm E: Elranatamab + DaratumumabEXPERIMENTAL -
Part 1EXPERIMENTALEvaluation of step-up priming dosing
Part 2AEXPERIMENTALDose determination
Part 2BEXPERIMENTALDose expansion
Part 2CEXPERIMENTALTo explore higher dose intensity
Elranatamab (cohort A)EXPERIMENTALBCMA-CD3 bispecific antibody
Elranatamab (cohort B)EXPERIMENTALBCMA-CD3 bispecific antibody
Part 1 Dose EscalationEXPERIMENTALNon-randomized elranatamab plus iberdomide
Part 2 Dose RandomizationEXPERIMENTALRandomized elranatamab plus iberdomide
Part 2A Dose EscalationEXPERIMENTALNon randomized Elranatamab plus Maplirpacept
Part 2B Dose RandomizationEXPERIMENTALRandomized dose level Elranatamab plus Maplirpacept
PF-06863135EXPERIMENTALBCMA-CD3 bispecific antibody
PF-06863135 + dexamethasoneEXPERIMENTALBCMA-CD3 bispecific antibody + dexamethasone
PF-06863135 + lenalidomideEXPERIMENTALBCMA-CD3 bispecific antibody + lenalidomide
PF-06863135 + pomalidomideEXPERIMENTALBCMA-CD3 bispecific antibody + pomalidomide
Interventions
NameTypeDescription
ElranatamabDRUGElranatamab will be administered subcutaneously
ElotuzumabDRUGElotuzumab will be administered intravenously
PomalidomideDRUGPomalidomide will be administered orally
DexamethasoneDRUGDexamethasone will be administered orally
BortezomibDRUGBortezomib will be administered subcutaneously or intravenously
CarfilzomibDRUGCarfilzomib will be administered intravenously
DaratumumabDRUGPart 1 Dose Level 1 is not randomized. All other cohorts are randomized.
LenalidomideDRUGPart 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Elranatamab (PF-06863135)DRUGBCMA-CD3 bispecific antibody
IberdomideDRUGcereblon-modulating agent
MaplirpaceptDRUGCD47-SIRP alpha-directed
PF-06863135 monotherapy IV or SCDRUGPF-06863135 will be administered intravenously or subcutaneously.
PF-06863135 + dexamethasoneDRUGPF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
PF-06863135 + lenalidomideDRUGPF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
PF-06863135 + pomalidomideDRUGPF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites271

Inclusion Criteria: * Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide. * Documented evidence of progr...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileCroatiaCzechiaDenmarkFinlandFranceGermanyGreeceIsraelItalyJapanNetherlandsNorwayPortugalSlovakiaSloveniaSouth KoreaSpainSwedenTaiwanUnited KingdomChinaPolandSwitzerlandAustriaHungaryIndiaTurkey (Türkiye)MexicoNew Zealand
Unlock Eligibility Criteria
Competitive Landscape -Multiple Myeloma 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT06152575lastUpdatePostDate: changed
LOWJun 5, 2026NCT06152575lastUpdatePostDate: changed
LOWJun 5, 2026NCT06152575lastUpdatePostDate: changed
LOWJun 5, 2026NCT06152575lastUpdatePostDate: changed
LOWMay 29, 2026NCT06152575lastUpdatePostDate: changed
LOWMay 29, 2026NCT06152575lastUpdatePostDate: changed
LOWMay 29, 2026NCT06152575lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT05623020primaryCompletionDate: changed
LOWMay 26, 2026NCT06215118primaryCompletionDate: changed
LOWMay 26, 2026NCT05020236primaryCompletionDate: changed
LOWMay 26, 2026NCT06152575primaryCompletionDate: changed
HIGHMay 26, 2026NCT05675449Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT05317416Enrollment: 811 → 854
LOWMay 26, 2026NCT04649359primaryCompletionDate: changed
LOWMay 24, 2026NCT05675449studyFirstPostDate: changed
LOWMay 24, 2026NCT05623020studyFirstPostDate: changed
LOWMay 24, 2026NCT06215118studyFirstPostDate: changed
LOWMay 24, 2026NCT05020236studyFirstPostDate: changed
LOWMay 24, 2026NCT06152575studyFirstPostDate: changed
LOWMay 24, 2026NCT05317416studyFirstPostDate: changed