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| ID | Type | Description | Link |
|---|---|---|---|
| MagnetisMM-9 | Other Identifier | Alias Study Number |
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The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses.
Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.
The purpose of the study (Part 1 and Part 2) of the study is to evaluate the safety (in particular the rate of Grade ≥ 2 CRS) of a step-up priming dose regimen of elranatamab in participants with relapsed/refractory multiple myeloma. In addition, this study will assess the safety of different dosing regimens of elranatamab and if it can provide a clinical benefit in those participants. 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 |
|---|---|---|---|
| Part 1 | Experimental | Evaluation of step-up priming dosing |
|
| Part 2A | Experimental | Dose determination |
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| Part 2B | Experimental | Dose expansion |
|
| Part 2C | Experimental | To explore higher dose intensity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab | Drug | BCMA-CD3 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2 | 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. | Parts 1 and 2: Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs): Part 2A | Hematological: grade 4 neutropenia lasting >5 days; febrile neutropenia; grade >=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with grade >=2 bleeding. Non-hematological: grade >=4 adverse events (AEs); grade 3 CRS (except CRS events: not been maximally treated or improved to grade <=1 within 48 hours); grade 3 AEs (except: AEs attributed to a CRS event; grade 3 nausea, vomiting and diarrhea that improve to grade <= 2 within 72 hours after maximal medical management has been initiated, grade 3 fatigue lasting <1 week; grade 3 AEs that recover to baseline or grade 1 within 5 days); confirmed drug-induced liver injury meeting Hy's law criteria; grade 3-4 laboratory abnormalities; other clinically important or persistent AEs; Grade 3 injection site reaction. CTCAE version 5.0: Grade 1: Mild AE, Grade 2: Moderate, Grade 3: severe, and grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. |
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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
ECOG performance status ≤1
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 |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic |
| 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. | |
| 40826257 |
| 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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Results are reported only for primary outcome measure and those secondary outcome measures whose analysis was final at primary completion date (15-June-2023). Remaining secondary outcome measures results would be reported once analysis is final.
In this study Part 2C was exploratory and there was no participant enrolled in Part 2C as it was not conducted. A total of 86 participants with relapsed/ refractory multiple myeloma were enrolled in this study and 85 participants were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 | Participants received elranatamab 4 milligram (mg) on Cycle (C) 1 Day 1 (D) [C1D1] and 20 mg on C1D4 and then 76 mg every week (QW) for 6 cycles. Thereafter, participants with partial response (PR) or better response persisting for greater than equal to (>=) 2 months on QW received 76 mg every 2 weeks (Q2W) and/or 116 mg or 152 mg every 4 weeks (Q4W) from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| 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 | Dec 20, 2023 | Jun 11, 2024 |
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| Part 2A: 28 days starting from the first 116 or 152 mg dose |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [All Causalities and Treatment Related]: Parts 1 and 2 | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed below: Results in death, requires inpatient hospitalization or prolongation of existing hospitalization, life-threatening, congenital anomaly/birth defect etc. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. | Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days) |
| Number of Participants With Maximum Grade 3 or 4 and Grade 5 AEs [All Causalities and Treatment Related] Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5: Parts 1 and 2 | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. AEs were graded according to NCI CTCAE version 5.0 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE. | Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days) |
| Number of Participants With Adverse Events of Special Interest (AESI)- CRS and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) [All Causalities and Treatment Related]: Parts 1 and 2 | CRS and ICANS were assessed according to ASTCT criteria. ASTCT for ICANS: Grade 1 [immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously]; Grade 2 [ICE score 3-6, awakens to voice]; Grade 3 [ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging]; Grade 4 [ICE 0 (unarousable and unable to perform ICE), Unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, Life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, Diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad]. | Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days) |
| Number of Participants With Hematological Measures With Baseline CTCAE Grade >=2 Shifted to a Maximum CTCAE Grade 3-4: Parts 1 and 2 | Hematology results were graded according to the NCI CTCAE version 5.0 for relevant parameters, Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated, Grade 5 indicates death related to AE. Hematological measures included Hemoglobin, Platelet count, WBC count, Plasma cell count. Absolute: Neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes, Plasma cells etc. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Number of Participants With Clinical Chemistry Parameters With Baseline CTCAE Grade >=2 Shifted to a Maximum CTCAE Grade 3-4: Parts 1 and 2 | Clinical chemistry data included BUN (Blood urea nitrogen), Creatinine, Glucose (non-fasting), Total Calcium, Sodium, Potassium, Chloride, Magnesium, Phosphorus or Phosphates, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total bilirubin, Alkaline phosphatase, Albumin, Chloride, Total CO2 (bicarbonate), Total protein, Lactate dehydrogenase (LDH), Uric acid, Serum beta-2 microglobulin. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Number of Participants With Liver Function Tests Abnormalities: Parts 1 and 2 | Alanine aminotransferase, aspartate aminotransferase, Alkaline Phosphatase, and total bilirubin (TBILI) were used to assess possible drug induced liver toxicity. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria as Determined by Investigator: Parts 1 and 2 | ORR: % of participants with objective response. stringent complete response (sCR):CR; ii) normal serum free light chain (FLC) ratio; absence of clonal cells in bone marrow biopsy (BMB)/ bone marrow aspirate (BMA) by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was normal serum FLC ratio of 0.26-1.65. VGPR:Serum and urine M-protein detectable by immunofixation but not on electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h; if only measurable disease is by serum FLC levels, VGPR:>=90% decrease in difference between involved and uninvolved serum FLC levels; in addition if present at baseline, >90% reduction compared to baseline in size of soft tissue plasmacytomas. PR:≥50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by ≥90% or to <200 mg/24 h. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Complete Response Rate (CRR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | CRR was defined as the percentage of participants with a BOR of confirmed sCR/CR per IMWG response criteria as determined by investigator. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Time to Response (TTR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | Time to response 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. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Duration of Response (DOR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | DOR: time from the first documentation of objective response, until confirmed PD, or death due to any cause, whichever occurred first. PD: Increase of >=25% from lowest confirmed response value in any 1 or more of following: serum M-component (absolute increase must be >=0.5 g/dL); serum M-protein increase >=1 g/dL, if lowest M component was >=5 g/dL; urine M-protein (absolute increase must be >=200 mg/24 h). In participants without measurable serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (absolute increase must be >10 mg/dL). In participants without measurable serum, urine M-protein levels and involved serum FLC levels, BM plasma-cell % irrespective of baseline status (must be >=10%). Appearance of a new lesion, >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of a previous lesion >1 cm in short axis. >=50% increase in circulating plasma cells (minimum of 200 cells per mcL) if only measure of disease. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Duration of Complete Response Rate (DOCR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | DOCR was defined as the time from the first documentation of sCR or CR that was subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurred first. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Progression Free Survival (PFS) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | PFS was defined as the time from the date of first dose until confirmed PD per IMWG criteria, or death due to any cause, whichever occurred first. Analysis was performed using Kaplan-Meier method. Participants with no PD event or death or who started a new anticancer therapy prior to an event or with an event after a gap of 2 or more missing disease assessments were censored on the date of last adequate disease assessment. Participants who did not have an adequate post-baseline disease assessment were censored on the date of first dose of study intervention unless death occurred on or before the time of the second planned disease assessment (<=8 weeks after the date of first dose) in which case the death was considered an event. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Overall Survival (OS): Parts 1 and 2 | OS was defined as the time from the date of first dose until death due to any cause. If a participant was not known to have died, survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier method. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria: Parts 1 and 2 | MRD negativity rate was defined as the percentage of participants with negative MRD (assessed by central laboratory) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first. Sequencing MRD negative included: 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as <2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10^5 nucleated cells. | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Pre- and Post-dose Concentrations of Elranatamab: Parts 1 and 2 | Parts 1 and 2: Till study completion approximately 3 years 7 months |
| Number of Participants With Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against Elranatamab: Parts 1 and 2 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Cancer Care & Hematology - Fort Collins | Fort Collins | Colorado | 80528 | United States |
| Poudre Valley Health System (PVHS) | Fort Collins | Colorado | 80528 | United States |
| UCHealth Cancer Care & Hematology - Greeley | Greeley | Colorado | 80634 | United States |
| UCHealth Cancer Care & Hematology - Loveland | Loveland | Colorado | 80538 | United States |
| UF Health Shands Cancer Hospital | Gainesville | Florida | 32608 | United States |
| UF Health Shands Hospital Pharmacy Investigational Drug Service - Main | Gainesville | Florida | 32610 | United States |
| UF Health Shands Hospital | Gainesville | Florida | 32610 | United States |
| East Jefferson General Hospital Bone Marrow Transplant Clinic | Metairie | Louisiana | 70006 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| The Regents of the University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| MSK Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| MSK Monmouth | Middletown | New Jersey | 07748 | United States |
| MSK Bergen | Montvale | New Jersey | 07645 | United States |
| MSK Commack | Commack | New York | 11725 | United States |
| MSK Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York | 11101 | United States |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| MSK Nassau | Uniondale | New York | 11553 | United States |
| Cleveland Clinic Taussig Cancer Institute | Cleveland | Ohio | 44195 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| St. David's South Austin Medical Center | Austin | Texas | 78704 | United States |
| Texas Oncology-South Austin | Austin | Texas | 78745 | United States |
| Blood Cancer and Stem Cell Transplant Clinic | San Antonio | Texas | 78229 | United States |
| Methodist Healthcare System of San Antonio dba Methodist Hospital | San Antonio | Texas | 78229 | United States |
| Methodist Hospital Investigational Pharmacy | San Antonio | Texas | 78229 | United States |
| Methodist Plaza Clinical Trials Office | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Japanese Red Cross Medical Center | Shibuya-ku | Tokyo | 150-8935 | Japan |
| University Hospital,Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| University College London Hospitals NHS Foundation Trust NIHR | London | W1T 7HA | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Surrey | SM2 5PT | United Kingdom |
| 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. |
| 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. |
| FG001 | Part 2A: Dose Level 1 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| FG002 | Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| FG003 | Part 2B | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants who received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for >= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| BG001 | Part 2A: Dose Level 1 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| BG002 | Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| BG003 | Part 2B | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2 | 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. | Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. Data for this outcome is presented for all participants in Part 1 and 2 of the study (combined) per study design, as all treatment groups utilized the same elranatamab priming regimen (4 mg on Day 1/20 mg on Day 4, followed by 76mg QW) during Cycle 1. | Posted | Count of Participants | Participants | Parts 1 and 2: Cycle 1 (28 days) |
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| Secondary | Number of Participants With Dose Limiting Toxicities (DLTs): Part 2A | Hematological: grade 4 neutropenia lasting >5 days; febrile neutropenia; grade >=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with grade >=2 bleeding. Non-hematological: grade >=4 adverse events (AEs); grade 3 CRS (except CRS events: not been maximally treated or improved to grade <=1 within 48 hours); grade 3 AEs (except: AEs attributed to a CRS event; grade 3 nausea, vomiting and diarrhea that improve to grade <= 2 within 72 hours after maximal medical management has been initiated, grade 3 fatigue lasting <1 week; grade 3 AEs that recover to baseline or grade 1 within 5 days); confirmed drug-induced liver injury meeting Hy's law criteria; grade 3-4 laboratory abnormalities; other clinically important or persistent AEs; Grade 3 injection site reaction. CTCAE version 5.0: Grade 1: Mild AE, Grade 2: Moderate, Grade 3: severe, and grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. | All enrolled participants in Part 2A who received the planned 2 doses of 116 mg or 152 mg of study intervention during the DLT observation period or who received at least 1 dose of 116 mg or 152 mg of study intervention and experience DLT(s) during the DLT observation period. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 and Part 2B of the study. | Posted | Count of Participants | Participants | Part 2A: 28 days starting from the first 116 or 152 mg dose |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [All Causalities and Treatment Related]: Parts 1 and 2 | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed below: Results in death, requires inpatient hospitalization or prolongation of existing hospitalization, life-threatening, congenital anomaly/birth defect etc. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. | Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Grade 3 or 4 and Grade 5 AEs [All Causalities and Treatment Related] Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5: Parts 1 and 2 | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. AEs were graded according to NCI CTCAE version 5.0 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE. | Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events of Special Interest (AESI)- CRS and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) [All Causalities and Treatment Related]: Parts 1 and 2 | CRS and ICANS were assessed according to ASTCT criteria. ASTCT for ICANS: Grade 1 [immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously]; Grade 2 [ICE score 3-6, awakens to voice]; Grade 3 [ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging]; Grade 4 [ICE 0 (unarousable and unable to perform ICE), Unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, Life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, Diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad]. | Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematological Measures With Baseline CTCAE Grade >=2 Shifted to a Maximum CTCAE Grade 3-4: Parts 1 and 2 | Hematology results were graded according to the NCI CTCAE version 5.0 for relevant parameters, Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated, Grade 5 indicates death related to AE. Hematological measures included Hemoglobin, Platelet count, WBC count, Plasma cell count. Absolute: Neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes, Plasma cells etc. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Chemistry Parameters With Baseline CTCAE Grade >=2 Shifted to a Maximum CTCAE Grade 3-4: Parts 1 and 2 | Clinical chemistry data included BUN (Blood urea nitrogen), Creatinine, Glucose (non-fasting), Total Calcium, Sodium, Potassium, Chloride, Magnesium, Phosphorus or Phosphates, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total bilirubin, Alkaline phosphatase, Albumin, Chloride, Total CO2 (bicarbonate), Total protein, Lactate dehydrogenase (LDH), Uric acid, Serum beta-2 microglobulin. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Liver Function Tests Abnormalities: Parts 1 and 2 | Alanine aminotransferase, aspartate aminotransferase, Alkaline Phosphatase, and total bilirubin (TBILI) were used to assess possible drug induced liver toxicity. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria as Determined by Investigator: Parts 1 and 2 | ORR: % of participants with objective response. stringent complete response (sCR):CR; ii) normal serum free light chain (FLC) ratio; absence of clonal cells in bone marrow biopsy (BMB)/ bone marrow aspirate (BMA) by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was normal serum FLC ratio of 0.26-1.65. VGPR:Serum and urine M-protein detectable by immunofixation but not on electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h; if only measurable disease is by serum FLC levels, VGPR:>=90% decrease in difference between involved and uninvolved serum FLC levels; in addition if present at baseline, >90% reduction compared to baseline in size of soft tissue plasmacytomas. PR:≥50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by ≥90% or to <200 mg/24 h. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | CRR was defined as the percentage of participants with a BOR of confirmed sCR/CR per IMWG response criteria as determined by investigator. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | Time to response 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 | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | DOR: time from the first documentation of objective response, until confirmed PD, or death due to any cause, whichever occurred first. PD: Increase of >=25% from lowest confirmed response value in any 1 or more of following: serum M-component (absolute increase must be >=0.5 g/dL); serum M-protein increase >=1 g/dL, if lowest M component was >=5 g/dL; urine M-protein (absolute increase must be >=200 mg/24 h). In participants without measurable serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (absolute increase must be >10 mg/dL). In participants without measurable serum, urine M-protein levels and involved serum FLC levels, BM plasma-cell % irrespective of baseline status (must be >=10%). Appearance of a new lesion, >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of a previous lesion >1 cm in short axis. >=50% increase in circulating plasma cells (minimum of 200 cells per mcL) if only measure of disease. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Response Rate (DOCR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | DOCR was defined as the time from the first documentation of sCR or CR that was subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurred first. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2 | PFS was defined as the time from the date of first dose until confirmed PD per IMWG criteria, or death due to any cause, whichever occurred first. Analysis was performed using Kaplan-Meier method. Participants with no PD event or death or who started a new anticancer therapy prior to an event or with an event after a gap of 2 or more missing disease assessments were censored on the date of last adequate disease assessment. Participants who did not have an adequate post-baseline disease assessment were censored on the date of first dose of study intervention unless death occurred on or before the time of the second planned disease assessment (<=8 weeks after the date of first dose) in which case the death was considered an event. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS): Parts 1 and 2 | OS was defined as the time from the date of first dose until death due to any cause. If a participant was not known to have died, survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier method. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria: Parts 1 and 2 | MRD negativity rate was defined as the percentage of participants with negative MRD (assessed by central laboratory) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first. Sequencing MRD negative included: 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as <2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10^5 nucleated cells. | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Pre- and Post-dose Concentrations of Elranatamab: Parts 1 and 2 | Not Posted | Oct 2026 | Parts 1 and 2: Till study completion approximately 3 years 7 months | Participants | |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against Elranatamab: Parts 1 and 2 | Not Posted | Oct 2026 | Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months) | Participants |
Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
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: number of deaths are reported from Day 1 of the study up to 90 days post last dose and deaths which occurred after 90 days post last dose of study drug are also included.
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 | Part 1 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for >= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 13 | 33 | 23 | 33 | 33 | 33 |
| EG001 | Part 2A: Dose Level 1 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 8 | 12 | 11 | 12 | 12 | 12 |
| EG002 | Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 4 | 11 | 8 | 11 | 10 | 11 |
| EG003 | Part 2B | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 8 | 29 | 21 | 29 | 28 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Deafness bilateral | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia proteus | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Muscle neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Non-systematic Assessment |
| |
| Small intestine adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
|
ASTCT: American Society for Transplantation and Cellular Therapy.
CTCAE: Common Terminology Criteria for Adverse Events.
g/dl: Gram/deciliter
mg: Milligram
BM: Bone marrow
Cm: Centimeter
SPD: Sum of the products of diameters
mcl: Microliter
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 | Jul 31, 2022 | Jun 11, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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 |
|
| OG001 | Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
|
|
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG002 | Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG003 | Part 2B | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
|
|
| Part 2A: Dose Level 1 |
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG002 | Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG003 | Part 2B | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
|
|
| OG001 | Part 2A: Dose Level 1 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG002 | Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| OG003 | Part 2B | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for >=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
|
|