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| ID | Type | Description | Link |
|---|---|---|---|
| MagnetisMM-3 | Other Identifier | Alias Study Number | |
| 2023-504479-25-00 | Registry Identifier | CTIS (EU) |
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The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elranatamab (cohort A) | Experimental | BCMA-CD3 bispecific antibody |
|
| Elranatamab (cohort B) | Experimental | BCMA-CD3 bispecific antibody |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab (PF-06863135) | Drug | BCMA-CD3 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria | 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. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline | 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. |
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Inclusion Criteria:
Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
Measurable disease, as defined by at least 1 of the following:
Refractory to at least one IMiD
Refractory to at least one PI
Refractory to at least one anti-CD38 antibody
Relapsed/refractory to last anti-myeloma regimen
Cohort A: has not received prior BCMA-directed therapy
Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
ECOG performance status ≤2
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
Not pregnant and willing to use contraception
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States | ||
| Chao Family Comprehensive Cancer Center and Ambulatory Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42287565 | Derived | Hibma JE, Irby D, Liu A, Elmeliegy M, King LE, Gifondorwa D, Jiang S, Poels KE, Soltantabar P, Lon HK, Shtylla B, Wang D, Williams JH, Nicholas T. Elranatamab Population Pharmacokinetics and Exposure-Response for Cytokine Release Syndrome in Patients with Relapsed or Refractory Multiple Myeloma. Clin Pharmacokinet. 2026 Jun 13. doi: 10.1007/s40262-026-01663-z. Online ahead of print. | |
| 42021581 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 187 participants were enrolled and assigned to study treatment. Results are reported at primary completion date. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at secondary completion date.
Participants with relapsed/refractory multiple myeloma (RRMM), who were refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-cluster of differentiation38 (CD38) monoclonal antibody were included. Study enrolled participants into 2 independent and parallel cohorts: cohort A and B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Participants who had not previously received a B-cell maturation antigen (BCMA)-directed therapy (BCMA-naïve participants) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W). The initial 4 enrolled participants received subcutaneous elranatamab with a priming regimen of 44 mg on Cycle 1 Day 1 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2023 | Jun 15, 2023 |
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| From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
| Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline | 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. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
| Duration of Response (DOR) as Per IMWG Criteria by BICR | DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) |
| Duration of Response as Per IMWG Criteria by Investigator Assessment | DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) |
| Complete Response Rate (CRR) as Per IMWG Criteria by BICR | CRR: % of participants with BOR of confirmed sCR/CR 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. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) |
| Complete Response Rate as Per IMWG Criteria by Investigator Assessment | CRR: % of participants with BOR of confirmed sCR/CR 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. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) |
| Objective Response Rate as Per IMWG Criteria by Investigator Assessment | 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. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) |
| Duration of Complete Response (DOCR) as Per IMWG Criteria by BICR | DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | From first documentation of sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) |
| Duration of Complete Response (DOCR) as Per IMWG Criteria by Investigator Assessment | DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | From first documentation of objective sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) |
| Progression Free Survival (PFS) as Per IMWG Criteria by BICR | PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) |
| Progression Free Survival (PFS) as Per IMWG Criteria by Investigator Assessment | PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) |
| Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of first dose until death due to any cause. | From the date of first dose until death due to any cause. Participants not known to have died were censored on the date of last known alive (up to approximately 20.14 months) |
| Time-to-Response (TTR) as Per IMWG Criteria by BICR | 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 was subsequently confirmed. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
| Time-to-Response (TTR) as Per IMWG Criteria by Investigator Assessment | 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 was subsequently confirmed. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) |
| Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria | MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | An adverse event (AE) 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. An AE was considered treatment-emergent relative to study intervention if the adverse event start date was during the on-treatment period (i.e. the time from the first dose of study intervention through the minimum of 90 days after last dose, or [start day of new anticancer therapy - 1 day]). CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening; Grade 5: death. | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) |
| Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Laboratory Parameters by NCI CTCAE v 5.0 | CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) |
| Number of Participants With Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria | CRS Grade 1: temperature >=38°C without hypotension or hypoxia; Grade 2: temperature >=38°C with hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula, facemask or blow-by; Grade 3: temperature >=38°C with hypotension requiring a vasopressor with or without vasopressin and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: temperature >=38°C with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation and mechanical ventilation); Grade 5: death. | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) |
| Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria | ICANS Grade 1: immune effector cell encephalopathy (ICE) score 7-9, participant awakens spontaneously; Grade 2: ICE score 3-6, participant awakens to voice; Grade 3: ICE score 0-2, participant awakens only to tactile stimulus, any clinical seizure focal or generalized that resolved rapidly or nonconvulsive seizures on electroencephalography that resolve with intervention or focal/local edema on neuroimaging; Grade 4: ICE score 0 (participant is unarousable and unable to perform ICE), participant unarousable or requires vigorous or repetitive tactile stimuli to arouse, life-threatening prolonged seizure (>5 min), repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness, diffuse cerebral edema on neuroimaging; decerebrate/decorticate posturing; cranial nerve VI palsy; papilledema, Cushing's triad; Grade 5: death. ICE: measures alterations in speech, orientation, handwriting, attention and receptive aphasia. | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) |
| Serum Concentration of Elranatamab | Total and free concentrations of Elranatamab on Cycle 4 Day 1 (C4D1) and Cycle 7 Day 1 (C7D1) were reported in this outcome measure. | Pre-dose on Day 1 of Cycle 4 and Pre-dose on Day 1 of Cycle 7 |
| Percentage of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) Against Elranatamab | From the date of first dose up to 20.14 months |
| Irvine |
| California |
| 92612 |
| United States |
| UCLA Hematology/Oncology Clinic | Los Angeles | California | 90095 | United States |
| UC Irvine Health - Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342 | United States |
| Northwestern Medical Group | Chicago | Illinois | 60611 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Loyola University Chicago performing research at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Regional Cancer Care Associates, LLC | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York | 11101 | United States |
| Weill Cornell Medical College - New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Weill Cornell Medical College - New York Presbyterian Hospital | New York | New York | 10065 | United States |
| St Francis Physician Services Inc | Greenville | South Carolina | 29601 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75204 | United States |
| St Vincent's Hospital (Melbourne) | Fitzroy | Victoria | 3065 | Australia |
| The Alfred | Melbourne | Victoria | 3004 | Australia |
| Epworth Healthcare | Richmond | Victoria | 3121 | Australia |
| CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| McGill University Health Centre - Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| CHU de Lille - Hopital Claude Huriez | Lille | 59037 | France |
| CHU de Nantes - Hôtel Dieu | Nantes | 44093 | France |
| Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique | Pierre-Bénite | 69495 | France |
| CHU de Poitiers, Pôle Régional de Cancérologie | Poitiers | 86021 | France |
| Universitätsklinikum Hamburg - Eppendorf | Hamburg | 20246 | Germany |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Gunma University Hospital | Maebashi | Gunma | 371-8511 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu | Poznan | 60-569 | Poland |
| Clinica Universitaria de Navarra | Madrid | 28027 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| Derived |
| Banerjee R, Mohan M, Shah B, Prince P, Gautam N, Beebe E, Pajerowski W, Cantu C, Meiseles H, Hughes D, Nador G, Sandin R, Hlavacek P, Li B, Meche A, Hyun Kim C, Perez Cruz I, Sumaya M, DiBonaventura M. Real-world treatment patterns and outcomes of patients with multiple myeloma initiating elranatamab: results from the ALTITUDE-1 and ALTITUDE-2 retrospective cohort studies. Future Oncol. 2026 May;22(11):1331-1340. doi: 10.1080/14796694.2026.2662504. Epub 2026 Apr 23. |
| 41968022 | Derived | Hebraud B, Charalampous C, Parrondo R, Chhabra S, Nagaraj M, DiBonaventura M, Duh MS, Bobbili PJ, Wang A, Frey-Koba S, Milce J, Levy M, Chafetz L, Faucher A, Johnson SMA, Hlavacek P, Cislo P, Hughes D, Nador G, Kumar SK. Comparison of Patient-Reported Outcomes for Elranatamab in MagnetisMM-3 Versus Real-World Physician Choice of Therapy for Triple-Class Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2026 Jun;26(6):e780-e792.e7. doi: 10.1016/j.clml.2026.03.014. Epub 2026 Mar 21. |
| 40830740 | Derived | Elmeliegy M, Soltantabar P, Hibma J, Ashman O, Wang D, Lon HK. Elranatamab Fixed Dosing: A Safe, Effective, and Convenient Dosing Approach. Target Oncol. 2025 Sep;20(5):821-831. doi: 10.1007/s11523-025-01170-4. Epub 2025 Aug 19. |
| 40826257 | Derived | Lon HK, Hibma J, Jiang S, Sullivan S, Vandendries E, Skoura A, Wang D, Elmeliegy M. Population Exposure-Response Efficacy Analysis of Elranatamab (PF-06863135) in Patients with Multiple Myeloma. Target Oncol. 2025 Sep;20(5):803-819. doi: 10.1007/s11523-025-01168-y. Epub 2025 Aug 18. |
| 40495704 | Derived | Gordan LN, Bensimon AG, Mu F, Kim N, Wu B, Lin D, Paner A, Fowler J, Marshall A, Van Sanden S, Ammann E, Goble J, Zhang X, Le HH, Min EE, Garrison LP Jr. Cost per responder for teclistamab and elranatamab in relapsed or refractory multiple myeloma in the United States. J Med Econ. 2025 Dec;28(1):910-920. doi: 10.1080/13696998.2025.2514909. Epub 2025 Jun 14. |
| 40000533 | Derived | Elmeliegy M, Viqueira A, Vandendries E, Hickman A, Conte U, Irby D, Hibma J, Lon HK, Piscitelli J, Soltantabar P, Skoura A, Jiang S, Wang D. Dose Optimization of Elranatamab to Mitigate the Risk of Cytokine Release Syndrome in Patients with Multiple Myeloma. Target Oncol. 2025 Mar;20(2):349-359. doi: 10.1007/s11523-025-01134-8. Epub 2025 Feb 25. |
| 38794892 | Derived | Iida S, Ito S, Yokoyama H, Ishida T, Nagai Y, Handa H, Ito S, Kamei Y, Nakamura M, Suzuki K. Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3. Jpn J Clin Oncol. 2024 Sep 4;54(9):991-1000. doi: 10.1093/jjco/hyae068. |
| 38078866 | Derived | Mol I, Hu Y, LeBlanc TW, Cappelleri JC, Chu H, Nador G, Aydin D, Schepart A, Hlavacek P. A matching-adjusted indirect comparison of the efficacy of elranatamab versus physician's choice of treatment in patients with triple-class exposed/refractory multiple myeloma. Curr Med Res Opin. 2024 Feb;40(2):199-207. doi: 10.1080/03007995.2023.2277850. Epub 2024 Jan 24. |
| 37582952 | Derived | Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, Rodriotaguez-Otero P, Martinez-Lopez J, Koehne G, Touzeau C, Jethava Y, Quach H, Depaus J, Yokoyama H, Gabayan AE, Stevens DA, Nooka AK, Manier S, Raje N, Iida S, Raab MS, Searle E, Leip E, Sullivan ST, Conte U, Elmeliegy M, Czibere A, Viqueira A, Mohty M. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023 Sep;29(9):2259-2267. doi: 10.1038/s41591-023-02528-9. Epub 2023 Aug 15. |
| FG001 | Cohort B | Participants who had previously received a BCMA-directed therapy (BCMA-exposed) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W). |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. |
| BG001 | Cohort B | BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria | 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. | Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
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| Secondary | Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline | 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. | Safety analysis set included all enrolled participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants with EMD at baseline. This outcome measure was planned only in Cohort A. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
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| Secondary | Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline | 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. | Safety analysis set included all enrolled participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants without EMD at baseline. This outcome measure was planned only in Cohort A. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
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| Secondary | Duration of Response (DOR) as Per IMWG Criteria by BICR | DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | Not Posted | Dec 2027 | From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response as Per IMWG Criteria by Investigator Assessment | DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | Not Posted | Dec 2027 | From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) as Per IMWG Criteria by BICR | CRR: % of participants with BOR of confirmed sCR/CR 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. | Not Posted | Dec 2027 | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate as Per IMWG Criteria by Investigator Assessment | CRR: % of participants with BOR of confirmed sCR/CR 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. | Not Posted | Dec 2027 | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate as Per IMWG Criteria by Investigator Assessment | 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. | Not Posted | Dec 2027 | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Response (DOCR) as Per IMWG Criteria by BICR | DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | Not Posted | Dec 2027 | From first documentation of sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Response (DOCR) as Per IMWG Criteria by Investigator Assessment | DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | Not Posted | Dec 2027 | From first documentation of objective sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) as Per IMWG Criteria by BICR | PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | Not Posted | Dec 2027 | From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) as Per IMWG Criteria by Investigator Assessment | PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | Not Posted | Dec 2027 | From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of first dose until death due to any cause. | Not Posted | Dec 2027 | From the date of first dose until death due to any cause. Participants not known to have died were censored on the date of last known alive (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time-to-Response (TTR) as Per IMWG Criteria by BICR | 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 was subsequently confirmed. | Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | Months | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) |
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| Secondary | Time-to-Response (TTR) as Per IMWG Criteria by Investigator Assessment | 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 was subsequently confirmed. | Not Posted | Dec 2027 | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria | MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria. | Not Posted | Dec 2027 | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | An adverse event (AE) 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. An AE was considered treatment-emergent relative to study intervention if the adverse event start date was during the on-treatment period (i.e. the time from the first dose of study intervention through the minimum of 90 days after last dose, or [start day of new anticancer therapy - 1 day]). CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening; Grade 5: death. | Not Posted | Dec 2027 | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Laboratory Parameters by NCI CTCAE v 5.0 | CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. | Not Posted | Dec 2027 | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria | CRS Grade 1: temperature >=38°C without hypotension or hypoxia; Grade 2: temperature >=38°C with hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula, facemask or blow-by; Grade 3: temperature >=38°C with hypotension requiring a vasopressor with or without vasopressin and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: temperature >=38°C with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation and mechanical ventilation); Grade 5: death. | Not Posted | Dec 2027 | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria | ICANS Grade 1: immune effector cell encephalopathy (ICE) score 7-9, participant awakens spontaneously; Grade 2: ICE score 3-6, participant awakens to voice; Grade 3: ICE score 0-2, participant awakens only to tactile stimulus, any clinical seizure focal or generalized that resolved rapidly or nonconvulsive seizures on electroencephalography that resolve with intervention or focal/local edema on neuroimaging; Grade 4: ICE score 0 (participant is unarousable and unable to perform ICE), participant unarousable or requires vigorous or repetitive tactile stimuli to arouse, life-threatening prolonged seizure (>5 min), repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness, diffuse cerebral edema on neuroimaging; decerebrate/decorticate posturing; cranial nerve VI palsy; papilledema, Cushing's triad; Grade 5: death. ICE: measures alterations in speech, orientation, handwriting, attention and receptive aphasia. | Not Posted | Dec 2027 | From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Elranatamab | Total and free concentrations of Elranatamab on Cycle 4 Day 1 (C4D1) and Cycle 7 Day 1 (C7D1) were reported in this outcome measure. | The pharmacokinetic (PK) analysis set was a subset of safety analysis set and included participants who had at least one post dose concentration measurement. Here, "Overall Number of Participants Analyzed" signifies maximum participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Pre-dose on Day 1 of Cycle 4 and Pre-dose on Day 1 of Cycle 7 |
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| Secondary | Percentage of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) Against Elranatamab | Not Posted | Dec 2027 | From the date of first dose up to 20.14 months | Participants |
From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A | BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. | 43 | 123 | 84 | 123 | 123 | 123 |
| EG001 | Cohort B | BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. | 30 | 64 | 44 | 64 | 63 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Blindness | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hepatitis fulminant | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Aspergilloma | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Parvovirus B19 infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia adenoviral | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Parvovirus B19 test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 antibody test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sarcopenia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Plasma cell myeloma refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
|
Due to character limitation in outcome measure description, SPD definition is provided here. SPD was defined as the sum of the products of the maximal perpendicular diameters of measured lesions. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at secondary completion date.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2022 | Jun 15, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| <0.0001 |
| Other |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|