MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

• ClinicalTrials.gov Identifier: NCT04649359
• Recruitment Status: Active, not recruiting
• First Posted: December 2, 2020
• Results First Posted: October 25, 2023
• Last Update Posted: April 30, 2024
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Elranatamab (PF-06863135)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 188 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
• Actual Study Start Date: February 2, 2021
• Actual Primary Completion Date: June 17, 2022
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Elranatamab (cohort A); BCMA-CD3 bispecific antibody	Drug: Elranatamab (PF-06863135); BCMA-CD3 bispecific antibody
Experimental: Elranatamab (cohort B); BCMA-CD3 bispecific antibody	Drug: Elranatamab (PF-06863135); BCMA-CD3 bispecific antibody

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) ]
   ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.

Secondary Outcome Measures :

1. Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) ]
   ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.
2. Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) ]
   ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.
3. Duration of Response (DOR) as Per IMWG Criteria by BICR [ Time Frame: From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) ]
   DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
4. Duration of Response as Per IMWG Criteria by Investigator Assessment [ Time Frame: From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) ]
   DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
5. Complete Response Rate (CRR) as Per IMWG Criteria by BICR [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) ]
   CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.
6. Complete Response Rate as Per IMWG Criteria by Investigator Assessment [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) ]
   CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.
7. Objective Response Rate as Per IMWG Criteria by Investigator Assessment [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) ]
   ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.
8. Duration of Complete Response (DOCR) as Per IMWG Criteria by BICR [ Time Frame: From first documentation of sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) ]
   DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
9. Duration of Complete Response (DOCR) as Per IMWG Criteria by Investigator Assessment [ Time Frame: From first documentation of objective sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) ]
   DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
10. Progression Free Survival (PFS) as Per IMWG Criteria by BICR [ Time Frame: From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) ]
    PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
11. Progression Free Survival (PFS) as Per IMWG Criteria by Investigator Assessment [ Time Frame: From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months) ]
    PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
12. Overall Survival (OS) [ Time Frame: From the date of first dose until death due to any cause. Participants not known to have died were censored on the date of last known alive (up to approximately 20.14 months) ]
    Overall survival (OS) was defined as the time from the date of first dose until death due to any cause.
13. Time-to-Response (TTR) as Per IMWG Criteria by BICR [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months) ]
    TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
14. Time-to-Response (TTR) as Per IMWG Criteria by Investigator Assessment [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) ]
    TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
15. Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria [ Time Frame: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months) ]
    MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria.
16. Number of Participants With Treatment Emergent Adverse Events (TEAE) Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) ]
    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment-emergent relative to study intervention if the adverse event start date was during the on-treatment period (i.e. the time from the first dose of study intervention through the minimum of 90 days after last dose, or [start day of new anticancer therapy - 1 day]). CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening; Grade 5: death.
17. Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Laboratory Parameters by NCI CTCAE v 5.0 [ Time Frame: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) ]
    CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
18. Number of Participants With Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria [ Time Frame: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) ]
    CRS Grade 1: temperature >=38°C without hypotension or hypoxia; Grade 2: temperature >=38°C with hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula, facemask or blow-by; Grade 3: temperature >=38°C with hypotension requiring a vasopressor with or without vasopressin and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: temperature >=38°C with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation and mechanical ventilation); Grade 5: death.
19. Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria [ Time Frame: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months) ]
    ICANS Grade 1: immune effector cell encephalopathy (ICE) score 7-9, participant awakens spontaneously; Grade 2: ICE score 3-6, participant awakens to voice; Grade 3: ICE score 0-2, participant awakens only to tactile stimulus, any clinical seizure focal or generalized that resolved rapidly or nonconvulsive seizures on electroencephalography that resolve with intervention or focal/local edema on neuroimaging; Grade 4: ICE score 0 (participant is unarousable and unable to perform ICE), participant unarousable or requires vigorous or repetitive tactile stimuli to arouse, life-threatening prolonged seizure (>5 min), repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness, diffuse cerebral edema on neuroimaging; decerebrate/decorticate posturing; cranial nerve VI palsy; papilledema, Cushing's triad; Grade 5: death. ICE: measures alterations in speech, orientation, handwriting, attention and receptive aphasia.
20. Serum Concentration of Elranatamab [ Time Frame: Pre-dose on Day 1 of Cycle 4 and Pre-dose on Day 1 of Cycle 7 ]
    Total and free concentrations of Elranatamab on Cycle 4 Day 1 (C4D1) and Cycle 7 Day 1 (C7D1) were reported in this outcome measure.
21. Percentage of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) Against Elranatamab [ Time Frame: From the date of first dose up to 20.14 months ]

Eligibility Criteria

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

Criteria

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
• Cohort A: has not received prior BCMA-directed therapy
• Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
• ECOG performance status ≤2
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
• Not pregnant and willing to use contraception

Exclusion Criteria:

• Smoldering multiple myeloma
• Active Plasma cell leukemia
• Amyloidosis
• POEMS syndrome
• Stem cell transplant within 12 weeks prior to enrollment
• 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.
• 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)

Contacts and Locations

Locations

United States, California

Beverly Hills Cancer Center

Beverly Hills, California, United States, 90211

UCLA Hematology/Oncology Clinic

Los Angeles, California, United States, 90095

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States, 90095

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868-3201

United States, Florida

Baptist Hospital of Miami

Miami, Florida, United States, 33176

Miami Cancer Institute

Miami, Florida, United States, 33176

United States, Georgia

Winship Cancer Institute @ Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Emory University Hospital

Atlanta, Georgia, United States, 30322

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States, 30342

Northside Hospital

Atlanta, Georgia, United States, 30342

United States, Illinois

Northwestern Medical Group

Chicago, Illinois, United States, 60611

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Loyola University Chicago performing research at Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, Indiana

Franciscan Health

Indianapolis, Indiana, United States, 46237

Indiana Blood and Marrow Transplantation-Administrative Offices

Indianapolis, Indiana, United States, 46237

Indiana Blood and Marrow Transplantation-Clinic

Indianapolis, Indiana, United States, 46237

United States, Iowa

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

United States, Kentucky

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States, 40207

Norton Women's and Children's Hospital

Louisville, Kentucky, United States, 40207

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care

New York, New York, United States, 10021

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States, 10021

Weill Cornell Medical College - New York-Presbyterian Hospital

New York, New York, United States, 10021

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States, 10065

United States, Pennsylvania

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

United States, South Carolina

St. Francis Hospital

Greenville, South Carolina, United States, 29601

Saint Francis Hospital Cancer Center

Greenville, South Carolina, United States, 29607

St Francis Eastside

Greenville, South Carolina, United States, 29615

United States, Texas

Baylor University Medical Center

Dallas, Texas, United States, 75246

Australia, Victoria

Epworth Healthcare

East Melbourne, Victoria, Australia, 3002

St Vincent's Hospital (Melbourne)

Fitzroy, Victoria, Australia, 3065

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

The Alfred

Melbourne, Victoria, Australia, 3004

Epworth Healthcare

Richmond, Victoria, Australia, 3050

Belgium

ZNA-Middelheim

Antwerpen, Belgium, 2020

ZNA Stuivenberg

Antwerpen, Belgium, 2060

Universitair Ziekenhuis Antwerpen

Edegem, Belgium, 2650

CHU UCL Namur site Godinne

Yvoir, Belgium, 5530

Canada, Alberta

Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Tom Baker Cancer Centre

Calgary, Alberta, Canada, T2N 4N2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, Quebec

CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada, H1T 2M4

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada, H4A 3J1

France

CHU de Lille - Hopital Claude Huriez

Lille, France, 59037

CHU de Nantes - Hôtel Dieu

Nantes Cedex 1, France, 44093

Hôpital Saint-Antoine

Paris Cedex 12, France, 75571

Hopital Saint-Louis

Paris, France, 75010

Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

Pierre Benite Cedex, France, 69495

CHU de Poitiers, Pôle Régional de Cancérologie

Poitiers Cedex, France, 86021

Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 09113

Universitätsklinikum Hamburg - Eppendorf

Hamburg, Germany, 20246

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Universitätsklinik Schleswig-Holstein

Kiel, Germany, 24105

Japan

Nagoya City University Hospital

Nagoya, Aichi, Japan, 467-8602

Gunma University Hospital

Maebashi, Gunma, Japan, 371-8511

Kobe City Medical Center General Hospital

Kobe-city, Hyogo, Japan, 650-0047

Iwate Medical University Hospital

Yahaba-cho, Shiwa-gun, Iwate, Japan, 028-3695

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan, 150-8935

Yamagata University Hospital

Yamagata, Japan, 990-9585

Poland

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

Bydgoszcz, Poland, 85-168

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

Poznan, Poland, 60-569

Uniwersytecki Szpital Kliniczny im.Jana Mikulicza -Radeckiego we Wroclawiu

Wroclaw, Poland, 50-367

Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruna, Spain, 15706

Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Clinica Universitaria de Navarra

Pamplona, Navarra, Spain, 31008

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Clinica Universitaria de Navarra

Madrid, Spain, 28027

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Universitario Doctor Peset

Valencia, Spain, 46017

United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] March 22, 2023

Statistical Analysis Plan  [PDF] October 26, 2022

More Information

Additional Information:

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

Open Science Registry 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04649359
• Other Study ID Numbers: C1071003; 2020-004533-21 ( EudraCT Number ); MagnetisMM-3 ( Other Identifier: Alias Study Number )
• First Posted: December 2, 2020
• Results First Posted: October 25, 2023
• Last Update Posted: April 30, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Myeloma; Multiple Myeloma; relapsed Multiple Myeloma; refractory Multiple Myeloma; PF-06863135; BCMA; bispecific; bispecific antibody; BCMA-CD3 bispecific; Elranatamab; MagnetisMM-3

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases