| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06152575 | 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) | PHASE3 | RECRUITING | 492 | — | — | Feb 8, 2024 | Dec 30, 2027 | Jun 5, 2026 | 271 | United States, Argentina +25 |
| NCT05623020 | 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 | PHASE3 | RECRUITING | 1,116 | — | — | Nov 10, 2022 | Oct 3, 2033 | May 14, 2026 | 89 | Australia, Canada +14 |
| NCT05317416 | Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant | PHASE3 | ACTIVE NOT_RECRUITING | 854 | — | — | Mar 25, 2022 | Oct 31, 2029 | Apr 16, 2026 | 209 | United States, Australia +25 |
| NCT05020236 | A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments | PHASE3 | RECRUITING | 944 | — | — | Oct 4, 2021 | May 31, 2027 | May 5, 2026 | 90 | United States, Argentina +20 |
| NCT05014412 | 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 | PHASE2 | COMPLETED | 86 | — | — | Oct 7, 2021 | Dec 12, 2025 | Feb 10, 2026 | 50 | United States, Japan +2 |
| NCT04649359 | MagnetisMM-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 mAb | PHASE2 | ACTIVE NOT_RECRUITING | 187 | — | — | Feb 2, 2021 | Dec 31, 2026 | May 19, 2026 | 40 | United States, Australia +6 |
| NCT06215118 | A 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 | 87 | — | — | Feb 20, 2024 | Mar 9, 2028 | May 22, 2026 | 43 | United States, Australia +1 |
| NCT05675449 | A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma | PHASE1 | ACTIVE NOT_RECRUITING | 59 | — | — | Dec 14, 2022 | Feb 29, 2028 | Apr 13, 2026 | 36 | United States, Israel |
| NCT03269136 | PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma | PHASE1 | COMPLETED | 101 | — | — | Nov 29, 2017 | Jan 19, 2024 | Mar 18, 2025 | 37 | United States, Canada |
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
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.
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.
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants
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.
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
Dose limiting toxicity based on dose limiting toxicity evaluable participants.
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Elranatamab | EXPERIMENTAL | Participants will receive elranatamab monotherapy |
| Investigator's Choice | ACTIVE_COMPARATOR | Participants 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 + Lenalidomide | EXPERIMENTAL | - |
| Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide | EXPERIMENTAL | - |
| Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide | EXPERIMENTAL | - |
| Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + Dexamethasone | ACTIVE_COMPARATOR | - |
| Part 1: Elranatamab + Lenalidomide | EXPERIMENTAL | - |
| Arm A - Part 1 | EXPERIMENTAL | Elranatamab |
| Arm B - Part 1 | ACTIVE_COMPARATOR | Lenalidomide |
| Arm B - Part 2 | ACTIVE_COMPARATOR | Lenalidomide |
| Arm C - Part 2 | EXPERIMENTAL | Elranatamab |
| Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab | EXPERIMENTAL | - |
| Part 2 Randomized Arm A: Elranatamab | EXPERIMENTAL | - |
| Part 2 Randomized Arm B: Elranatamab + Daratumumab | EXPERIMENTAL | - |
| Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone | ACTIVE_COMPARATOR | - |
| Part 3 Arm D: Elranatamab | EXPERIMENTAL | - |
| Part 3 Arm E: Elranatamab + Daratumumab | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | Evaluation of step-up priming dosing |
| Part 2A | EXPERIMENTAL | Dose determination |
| Part 2B | EXPERIMENTAL | Dose expansion |
| Part 2C | EXPERIMENTAL | To explore higher dose intensity |
| Elranatamab (cohort A) | EXPERIMENTAL | BCMA-CD3 bispecific antibody |
| Elranatamab (cohort B) | EXPERIMENTAL | BCMA-CD3 bispecific antibody |
| Part 1 Dose Escalation | EXPERIMENTAL | Non-randomized elranatamab plus iberdomide |
| Part 2 Dose Randomization | EXPERIMENTAL | Randomized elranatamab plus iberdomide |
| Part 2A Dose Escalation | EXPERIMENTAL | Non randomized Elranatamab plus Maplirpacept |
| Part 2B Dose Randomization | EXPERIMENTAL | Randomized dose level Elranatamab plus Maplirpacept |
| PF-06863135 | EXPERIMENTAL | BCMA-CD3 bispecific antibody |
| PF-06863135 + dexamethasone | EXPERIMENTAL | BCMA-CD3 bispecific antibody + dexamethasone |
| PF-06863135 + lenalidomide | EXPERIMENTAL | BCMA-CD3 bispecific antibody + lenalidomide |
| PF-06863135 + pomalidomide | EXPERIMENTAL | BCMA-CD3 bispecific antibody + pomalidomide |
| Name | Type | Description |
|---|---|---|
| Elranatamab | DRUG | Elranatamab will be administered subcutaneously |
| Elotuzumab | DRUG | Elotuzumab will be administered intravenously |
| Pomalidomide | DRUG | Pomalidomide will be administered orally |
| Dexamethasone | DRUG | Dexamethasone will be administered orally |
| Bortezomib | DRUG | Bortezomib will be administered subcutaneously or intravenously |
| Carfilzomib | DRUG | Carfilzomib will be administered intravenously |
| Daratumumab | DRUG | Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. |
| Lenalidomide | DRUG | Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. |
| Elranatamab (PF-06863135) | DRUG | BCMA-CD3 bispecific antibody |
| Iberdomide | DRUG | cereblon-modulating agent |
| Maplirpacept | DRUG | CD47-SIRP alpha-directed |
| PF-06863135 monotherapy IV or SC | DRUG | PF-06863135 will be administered intravenously or subcutaneously. |
| PF-06863135 + dexamethasone | DRUG | PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally. |
| PF-06863135 + lenalidomide | DRUG | PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally |
| PF-06863135 + pomalidomide | DRUG | PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally |
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...