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Elranatamab

Phase 3

Multiple Myeloma, Newly Diagnosed | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jul 9, 2026

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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment924
FDA Designations
No designations recorded
Clinical trial landscape

Elranatamab · 16 trials · 19 indications

Phase 3 5Phase 2 7Phase 1 4
NCT06918002Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM PatientsMultiple Myeloma, Newly Diagnosed
RECRUITING824 Analytics
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)Multiple Myeloma
RECRUITING492 Analytics
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 TransplantMultiple Myeloma
RECRUITING1,116 Analytics
NCT05317416Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After TransplantMultiple Myeloma
ACTIVE NOT_RECRUITING854 Analytics
NCT05020236A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other TreatmentsMultiple Myeloma
RECRUITING944 Analytics
PHASE3RECRUITING
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
Multiple Myeloma, Newly DiagnosedUnlock trial analytics
PHASE3RECRUITING
MagnetisMM-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)
Multiple MyelomaUnlock trial analytics
PHASE3RECRUITING
A 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 Transplant
Multiple MyelomaUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
Multiple MyelomaUnlock trial analytics
PHASE3RECRUITING
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
Multiple MyelomaUnlock trial analytics
Study Endpoints
Primary Endpoints
Part 1 (induction/consolidation) from Randomization 1 (R1): to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Minimal Residual Disease (MRD) negativity rate
at end of consolidation, up to 36 months

To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of MRD negativity rate.

Part 2 (maintenance) from Randomization 2 (R2): to assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of Progression Free Survival (PFS).
from the date of second randomization to the date of confirmed PD (IMWG criteria,) or death from any cause, whichever came first, assessed up to 93 monts

To assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of PFS.

Key secondary objectives: Part 1 (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS
PFS defined as the time interval from the date of first randomization to the date of confirmed Progression Disease (IMWG criteria) or death from any cause, whichever occurs first., assessed up to 128 months

To assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS

Key secondary objectives: Part I (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Overal Survival (OS)
up to 128 months

To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of OS

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
Evaluation of Elra consolidation therapy
12 weeks ( 3 cycles)

Evaluation of completion of (Elra) consolidation following definitive therapy in patients with PBL, defined as the proportion of patients completing at least 3 cycles

Estimate the complete response in HIV+/ HIV- patients
6 months

Estimate the complete response (CR) rate (per 2014 LUGANO criteria)Ref . in HIV-positive and HIV-negative patients after 6 months of consolidation.

Evaluate the safety and tolerability of Elra consolidation
6 months

To evaluate the safety and tolerability of Elra consolidation, including the incidence, severity, and management of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), assessed by ASTCT consensus criteria.

Incidence of Cytokine Release Syndrome (CRS) in Cycle 1
From Cycle 1 Day 1 to Cycle 1 Day 28 for all participants. Each cycle is 28 days.

Evaluate the number of participants with events of CRS during Cycle 1 of study treatment. CRS events will be graded per the American Society for Transplantation and Cellular Therapy grading (ASTCT 2019).

Rate of MRD negativity after completion of Maintenance 1
At 60 weeks

Rate of participants with MRD negativity (defined as \<10-5) after completion of the Maintenance 1 portion of the study.

Hospitalization rate
2 weeks

Hospitalization rate, defined as the number of patients who are hospitalized within the first 2 weeks of Cycle 1 of treatment, due to any cause, divided by the number of patients who are treated with elranatamab.

Rate of grade 3+ infections
24 months

Rate of grade 3+ infections as grade by NCI CTCAE v5 within the first 24 months of treatment, defined as the number of patients who experience a grade 3+ infection within 24 months of treatment, divided by the number of patients who are treated with elranatamab.

Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)
Cycle 1 (28 days)

Grade(G)4 neutropenia \>5 day; febrile neutropenia (absolute neutrophil count \[ANC\] \<1000/millimeter cube (mm\^3) with single temperature \>38.3 degree Celsius (deg C) or sustained temp\>=38 deg C for \>1 hour(H); G\>=3 neutropenia with infection; G4 thrombocytopenia (unless baseline count \>=25,000/mm\^3 and \<50,000/mm\^3, in which case G4 thrombocytopenia to be accompanied by \>=G2 bleeding); Platelet count \<10,000/mm\^3; G3 thrombocytopenia with \>=G2 bleeding; G\>=4 AE; G3 cytokine release syndrome(CRS) except CRS not maximally treated/improved to \<=G1 within 48H; G3 AE except AE attributed to CRS, G3 nausea,vomiting,diarrhea improved to G\<=2 within 72H after medical management, G3 fatigue \<1 week, G3 AE recovered to baseline/G1 within 5 day; confirmed drug-induced liver injury; G3-4 laboratory (lab) abnormality except G3-4 lab abnormality improved to G\<=2 within 72H after medical management \& without sequelae;G3 injection site reaction; G2/other clinically important AE may be considered DLT.

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 (approximately up to 16 months)

ORR: Percentage 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.

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.

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.

Number of Participants With Dose Limiting Toxicities (DLTs)
Up to 4 weeks

DLT was defined as any of the following: Treatment Emergent Adverse Events (AEs) occurring in Cycle 0 and Cycle 1 (total 4 weeks): Grade (G) 4 neutropenia lasting greater than (\>)7 days; febrile neutropenia (absolute neutrophil count \[ANC\] less than (\<)1,000 per millimeter cube (/mm\^3) with single temperature \>38.3 degree Celsius (deg C), or sustained temperature of greater than or equal to (\>=) 38deg C for \>1 hour \[h\]); G\>=3 neutropenia with infection; G4 thrombocytopenia (unless the baseline count was \>=25,000/mm\^3 and \<50,000/mm\^3, in which case G4 thrombocytopenia was to be accompanied by \>=G2 bleeding), Platelet count \<10,000/mm\^3 was considered a DLT irrespective of other factors; G3 thrombocytopenia with \>=G2 bleeding; G4 AEs; G3 AE \>=5 days despite optimal supportive care (except AEs attributed to cytokine release syndrome \[CRS\]); G3 CRS (except CRS that have not been maximally treated or improved to \<=G1 within 48h); confirmed drug induced liver injury.

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
Part 1 (induction/consolidation) from R1: to assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care
End of consolidation phase, up to 36 months
Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab
end of maintenance, up to 58 months
assess safety & Tolerability during induction, and during consolidation and maintenance therapy: Adverse events (AE), serious Adrverse events (SAE) and And adverse events of special interest (AESI) rates - Incidence of Treatment-Emergent Adverse Events
through study completion, up to 128 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
D-VRD induction, ASCT and D-VRD consolidation (arm A)ACTIVE_COMPARATORStandard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, and 2 cycles of D-VRd consolidation therapy
D-VRD induction followed by elranatamab and lenalidomide consolidation (arm B)EXPERIMENTALStandard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.
daratumumab + lenalidomide maintenance (Arm C)ACTIVE_COMPARATORDaratumumab + Lenalidomide for two years (maintenance)
elranatamab maintenance (Arm D)EXPERIMENTALElranatamab monotherapy for two years (maintenance)
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 -
Single-arm Open label study of Elra of pts with PBLEXPERIMENTALPatients will receive Elra subcutaneously for up to six 28-day cycles, beginning with a step-up dosing schedule (12 mg on day 1, 32 mg on day 4, followed by 76 mg weekly on days 8, 15, and 22 of Cycle 1). Patients will transition to 76 mg every 2 weeks (days 1 and 15) during Cycles 2 and 3, followed by an interim PET/CT assessment at the end of Cycle 3. During Cycles 4 through 6, all patients will receive 76 mg every 4 weeks (on day 1 of each cycle).
Safety Lead-in (Cohort 1)EXPERIMENTALParticipants will receive a single intravenous (IV) dose of tocilizumab prior to the first step-up dose (SUD) of elranatamab. Elranatamab will be administered subcutaneously (SC) each cycle. Cycles will be 28 days. 6 participants will be enrolled into this Lead-In Cohort 1 to evaluate safety of regimen before proceeding to enroll into Expansion cohort.
Expansion (Cohort 2)EXPERIMENTALParticipants will receive a single intravenous (IV) dose of tocilizumab prior to the first step-up dose (SUD) of elranatamab. Elranatamab will be administered subcutaneously (SC) each cycle. Cycles will be 28 days. 40 participants will be enrolled into this Expansion Cohort 2.
Arm A (Elranatamab + Daratumumab)EXPERIMENTALParticipants will receive step up dosing of Elranatamab subcutaneously in first cycle followed by weekly dosing for the remainder of the cycle 1. In cycle 2 and 3, elranatamab will be administered every two weeks (Consolidation portion). This will be followed by elranatamab every 4 weeks for 12 cycles in the Maintenance 1 portion. Daratumumab will be given subcutaneously at a fixed dose every 4 weeks starting at Cycle 2 and 3 of Consolidation and for 12 cycles in the Maintenance 1 portion of the study. After completion of Maintenance 1, participants with MRD negativity will receive Elranatamab monotherapy every 4 weeks for additional 12 cycles in Maintenance 2 portion. Participants with MRD positivity will proceed to Arm A1. Participants will undergo therapy in the assigned arm until disease progression, permanent discontinuation (irrespective of reason), death or completion of planned therapy. Cycles will be 28 days. Consolidation consists of 3 cycles; Maintenance 1 consists of 12
Arm B (ASCT + lenalidomide/daratumumab)ACTIVE_COMPARATORParticipants will undergo ASCT according to standard of care institutional practices in the Consolidation portion of the study followed by twelve 28-day cycles of Lenalidomide and Daratumumab in the Maintenance 1 portion. After completion of Maintenance 1, participants with MRD negativity will receive Lenalidomide monotherapy for additional 12 cycles in Maintenance 2 portion. Participants with MRD positivity will proceed to Arm B1. Participants will undergo therapy in the assigned arm until disease progression, permanent discontinuation (irrespective of reason), death or completion of planned therapy. Cycles will be 28 days. Consolidation consists of ASCT; Maintenance 1 consists of 12 cycles; Maintenance 2 consists of 12 cycles. Up to 50 participants will be enrolled to this arm.
Arm A1 (Late Intensification)EXPERIMENTALParticipants randomized to Arm A that have MRD positivity after Maintenance 1 will undergo ASCT according to standard of care institutional practices followed by twelve 28-day cycles of maintenance treatment with Lenalidomide and Daratumumab in the Late Intensification portion of the study.
Arm B1 (Late Intensification)EXPERIMENTALParticipants randomized to Arm B that have MRD positivity after Maintenance 1 will receive Elranatamab in combination with Daratumumab for three 28-day cycles as consolidation, followed by Elranatamab in combination with Daratumumab for additional twelve 28-day cycles of maintenance treatment in the Late Intensification portion of the study.
Elranatamab injectionEXPERIMENTALThe administration of two step-up elranatamab doses (12 mg and 32 mg) and full dose 76 mg. The dosing interval for the first Cycle (each cycle q28 days) is every week. Cycles 2-3, the dosing interval increases to q2weeks. Cycles 4-12, the dosing interval increases to q4weeks. Cycles 13+, further dosing interval increases to q8weeks will be scheduled if a participant meets criteria for IMWG complete response (CR) in Cycle 12 (bone marrow required at Cycle 12 to confirm). If a participant does not meet CR criteria at Cycle 12, they will be continued on Q4W dosing.
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
Elranatamab (PF-06863135)EXPERIMENTALBCMA-CD3 bispecific antibody
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 is given to arm B patients in association with lenalidomide (for consolidation) and arm D patients in monotherapy (for maintenance) as experimental arms
Lenalidomide (Revlimid®)DRUGIn association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C)
Daratumumab SC (Darzalex)DRUGDaratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A
Autologous Stem Cell TransplantationPROCEDUREASCT is performed in consolidation for Arm A patients after induction therapy with D-VRD
Bortezomib (Velcade®)DRUGBortezomib is given in associtaion with daratumumab, lenalidomide and dexamethasone in induction (all patients) and consolidation Arm A
DexamethasoneDRUGDexamethasone is given in association with daratumumab, bortezomib and lenalidomide in induction (all patients) and consolidation Arm A
ElotuzumabDRUGElotuzumab will be administered intravenously
PomalidomideDRUGPomalidomide 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 (Elra)DRUGElra will be administered subcutaneously on day 1, day 4, then weekly on day 8, 15 and day 22 completing 1 cycle. Up to 6 cycles may be given.
TocilizumabDRUGA single (one time) intravenous (IV) dose of tocilizumab 8 mg/kg will be administered 1-4 hours prior to the first step-up dose (SUD) of elranatamab in Cycle 1. Cycles will be 28 days.
Elranatamab injectionDRUGElranatamab (Elrexfio) is a humanized bispecific antibody that targets both BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells.
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
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Eligibility Criteria
Age Range18 Years to 69 Years
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: 1. Male or female subjects, aged over 18 but \< 70 years old 2. Patients have provided voluntary written informed consent before performing any study-related procedure. 3. Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and a...

Countries:FranceUnited StatesArgentinaAustraliaBelgiumBrazilCanadaChileCroatiaCzechiaDenmarkFinlandGermanyGreeceIsraelItalyJapanNetherlandsNorwayPortugalSlovakiaSloveniaSouth KoreaSpainSwedenTaiwanUnited KingdomAustriaChinaNew ZealandPolandPuerto RicoSwitzerlandHungaryIndiaTurkey (Türkiye)Mexico
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