A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment (MagnetisMM-9)

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 602-8566
    • University Hospital,Kyoto Prefectural University of Medicine
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Japanese Red Cross Medical Center
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals Nhs Foundation Trust
  • London, United Kingdom, W1T 7HA
    • University College London Hospitals NHS Foundation Trust NIHR
  • Surrey, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • Colorado
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Fort Collins, Colorado, United States, 80528
      • Poudre Valley Health System (PVHS)
    • Fort Collins, Colorado, United States, 80528
      • Cancer Care & Hematology - Fort Collins
    • Greeley, Colorado, United States, 80634
      • UCHealth Cancer Care & Hematology - Greeley
    • Loveland, Colorado, United States, 80538
      • UCHealth Cancer Care & Hematology - Loveland
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health Shands Hospital
    • Gainesville, Florida, United States, 32608
      • UF Health Shands Cancer Hospital
    • Gainesville, Florida, United States, 32610
      • UF Health Shands Hospital Pharmacy Investigational Drug Service - Main
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • East Jefferson General Hospital
    • Metairie, Louisiana, United States, 70006
      • East Jefferson General Hospital Bone Marrow Transplant Clinic
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The Regents of the University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • MSK Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • MSK Monmouth
    • Montvale, New Jersey, United States, 07645
      • MSK Bergen
  • New York
    • Commack, New York, United States, 11725
      • MSK Commack
    • Harrison, New York, United States, 10604
      • MSK Westchester
    • Long Island City, New York, United States, 11101
      • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
    • Uniondale, New York, United States, 11553
      • MSK Nassau
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology-South Austin
    • Austin, Texas, United States, 78704
      • St. David's South Austin Medical Center
    • San Antonio, Texas, United States, 78229
      • Blood Cancer and Stem Cell Transplant Clinic
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare System of San Antonio dba Methodist Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital Investigational Pharmacy
    • San Antonio, Texas, United States, 78229
      • Methodist Plaza Clinical Trials Office
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute, University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

• Measurable disease, as defined by at least 1 of the following:

  1. Serum M-protein >0.5 g/dL by SPEP
  2. Urinary M-protein excretion >200 mg/24 hours by UPEP
  3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
• 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:

• Smoldering multiple myeloma
• Active Plasma cell leukemia
• POEMS syndrome
• Amyloidosis
• Waldenström's macroglobulinemia
• Known active CNS involvement or clinical signs of myelomatous meningeal involvement
• Stem cell transplant within 12 weeks prior to enrollment or active GVHD
• Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
• Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
• Live attenuated vaccine within 4 weeks of the first dose
• Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
• Known or suspected hypersensitivity to the study intervention, or any of its excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Evaluation of step-up priming dosing	Drug: Elranatamab; BCMA-CD3 bispecific antibody
Experimental: Part 2A; Dose determination	Drug: Elranatamab; BCMA-CD3 bispecific antibody
Experimental: Part 2B; Dose expansion	Drug: Elranatamab; BCMA-CD3 bispecific antibody
Experimental: Part 2C; To explore higher dose intensity	Drug: Elranatamab; BCMA-CD3 bispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): December 12, 2025

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; monoclonal antibody; RRMM; Phase 2; BCMA; Elranatamab; Targeted T-cell; MagnetisMM; B-Cell Maturation Antigen; Relapse/Refractory; MM9
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: C1071009; MagnetisMM-9 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No