Multiple MyelomaPhase 2NCT04649359
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
A Phase 2 study testing Elranatamab (PF-06863135) in people with Multiple Myeloma, run by Pfizer at 78 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Elranatamab (PF-06863135)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 78 sitesin 10 countries
- Study dates
- 2 Feb 2021to 25 Aug 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
- Measurable disease, as defined by at least 1 of the following:
- Serum M-protein >0.5 g/dL by SPEP
- Urinary M-protein excretion >200 mg/24 hours by UPEP
- Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- Refractory to at least one IMiD
Show all 14Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
78 sites in 10 countries.
78 sites in 10 countries
United States37 sites
Winship Cancer Institute @ Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern Medical Group
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Baylor University Medical Center
Dallas, Texas, 75246
St. Francis Hospital
Greenville, South Carolina, 29601
Saint Francis Hospital Cancer Center
Greenville, South Carolina, 29607
St Francis Eastside
Greenville, South Carolina, 29615
Hackensack University Medical Center
Hackensack, New Jersey, 07601
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237
University of Iowa - Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
The Regents of the University of California
Irvine, California, 92697
Memorial Sloan Kettering Cancer Center-Investigational Drug Service Pharmacy
Long Island City, New York, 11101
UCLA Hematology/Oncology Clinic
Los Angeles, California, 90095
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
Loyola University Chicago performing research at Loyola University Medical Center
Maywood, Illinois, 60153
Baptist Hospital of Miami
Miami, Florida, 33176
Miami Cancer Institute
Miami, Florida, 33176
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10021
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Japan7 sites
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Gunma University Hospital
Maebashi, Gunma, 371-8511
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935
Iwate Medical University Hospital
Yahaba-cho, Iwate, 028-3695
Yamagata University Hospital
Yamagata, 990-9585
Spain7 sites
Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clinic de Barcelona
Barcelona, 08036
Clinica Universitaria de Navarra
Madrid, 28027
Hospital Universitario 12 de Octubre
Madrid, 28041
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruna, 15706
Hospital Universitario Doctor Peset
Valencia, 46017
France6 sites
CHU de Lille - Hopital Claude Huriez
Lille, 59037
CHU de Nantes - Hôtel Dieu
Nantes, 44093
Hopital Saint-Louis
Paris, 75010
Hôpital Saint-Antoine
Paris, 75012
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
Pierre-Bénite, 69495
CHU de Poitiers, Pôle Régional de Cancérologie
Poitiers, 86021
Canada5 sites
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1
Australia4 sites
Epworth Healthcare
East Melbourne, Victoria, 3002
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065
The Alfred
Melbourne, Victoria, 3004
Epworth Healthcare
Richmond, Victoria, 3121
Belgium4 sites
ZNA-Middelheim
Antwerp, 2020
ZNA Stuivenberg
Antwerp, 2060
Universitair Ziekenhuis Antwerpen
Edegem, 2650
CHU UCL Namur site Godinne
Yvoir, 5530
Germany4 sites
Klinikum Chemnitz gGmbH
Chemnitz, 09113
Universitätsklinikum Hamburg - Eppendorf
Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinik Schleswig-Holstein
Kiel, 24105
Poland3 sites
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, 60-569
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-367
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
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
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.
- Conditions
- Multiple Myeloma
- Being tested
- Elranatamab (PF-06863135)
- Keywords
- Myeloma, Multiple Myeloma, relapsed Multiple Myeloma, refractory Multiple Myeloma, PF-06863135, BCMA, bispecific, bispecific antibody, BCMA-CD3 bispecific, Elranatamab, MagnetisMM-3
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elranatamab (PF-06863135)Drug
BCMA-CD3 bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Elranatamab (cohort A) | Experimental | BCMA-CD3 bispecific antibody Receives: Drug: Elranatamab (PF-06863135) |
| Elranatamab (cohort B) | Experimental | BCMA-CD3 bispecific antibody Receives: Drug: Elranatamab (PF-06863135) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein \& urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: >=90% \& >=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, >=90% \& >=50% reduction in soft tissue plasmacytomas' size.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Secondary outcomes (21)
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline
ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein \& urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: >=90% \& >=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, >=90% \& >=50% reduction in soft tissue plasmacytomas' size.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline
ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein \& urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: >=90% \& >=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, >=90% \& >=50% reduction in soft tissue plasmacytomas' size.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Duration of Response (DOR) as Per IMWG Criteria by BICR
DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Measured: From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Duration of Response as Per IMWG Criteria by Investigator Assessment
DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Measured: From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Complete Response Rate (CRR) as Per IMWG Criteria by BICR
CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Complete Response Rate as Per IMWG Criteria by Investigator Assessment
CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Objective Response Rate as Per IMWG Criteria by Investigator Assessment
ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein \& urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: >=90% \& >=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, >=90% \& >=50% reduction in soft tissue plasmacytomas' size.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Duration of Complete Response (DOCR) as Per IMWG Criteria by BICR
DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Measured: From first documentation of sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Duration of Complete Response (DOCR) as Per IMWG Criteria by Investigator Assessment
DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Measured: From first documentation of objective sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Progression Free Survival (PFS) as Per IMWG Criteria by BICR
PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Measured: From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Progression Free Survival (PFS) as Per IMWG Criteria by Investigator Assessment
PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Measured: From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Overall Survival (OS)
Overall survival (OS) was defined as the time from the date of first dose until death due to any cause.
Measured: From the date of first dose until death due to any cause. Participants not known to have died were censored on the date of last known alive (up to approximately 20.14 months)
Time-to-Response (TTR) as Per IMWG Criteria by BICR
TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Time-to-Response (TTR) as Per IMWG Criteria by Investigator Assessment
TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria
MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria.
Measured: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Number of Participants With Treatment Emergent Adverse Events (TEAE) Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment-emergent relative to study intervention if the adverse event start date was during the on-treatment period (i.e. the time from the first dose of study intervention through the minimum of 90 days after last dose, or [start day of new anticancer therapy - 1 day]). CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening; Grade 5: death.
Measured: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Laboratory Parameters by NCI CTCAE v 5.0
CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
Measured: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Number of Participants With Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria
CRS Grade 1: temperature >=38°C without hypotension or hypoxia; Grade 2: temperature >=38°C with hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula, facemask or blow-by; Grade 3: temperature >=38°C with hypotension requiring a vasopressor with or without vasopressin and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: temperature >=38°C with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation and mechanical ventilation); Grade 5: death.
Measured: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria
ICANS Grade 1: immune effector cell encephalopathy (ICE) score 7-9, participant awakens spontaneously; Grade 2: ICE score 3-6, participant awakens to voice; Grade 3: ICE score 0-2, participant awakens only to tactile stimulus, any clinical seizure focal or generalized that resolved rapidly or nonconvulsive seizures on electroencephalography that resolve with intervention or focal/local edema on neuroimaging; Grade 4: ICE score 0 (participant is unarousable and unable to perform ICE), participant unarousable or requires vigorous or repetitive tactile stimuli to arouse, life-threatening prolonged seizure (>5 min), repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness, diffuse cerebral edema on neuroimaging; decerebrate/decorticate posturing; cranial nerve VI palsy; papilledema, Cushing's triad; Grade 5: death. ICE: measures alterations in speech, orientation, handwriting, attention and receptive aphasia.
Measured: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Serum Concentration of Elranatamab
Total and free concentrations of Elranatamab on Cycle 4 Day 1 (C4D1) and Cycle 7 Day 1 (C7D1) were reported in this outcome measure.
Measured: Pre-dose on Day 1 of Cycle 4 and Pre-dose on Day 1 of Cycle 7
Percentage of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) Against Elranatamab
Measured: From the date of first dose up to 20.14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start2 Feb 2021
- Primary completion17 Jun 2022
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649359
- Sponsor's protocol ID
- C1071003
- Other IDs
- MagnetisMM-3, 2023-504479-25-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 6 Nov 2020
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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 Aug;65(8):1173-1192. doi: 10.1007/s40262-026-01663-z. Epub 2026 Jun 13.
PubMed 42287565Banerjee R, Mohan M, Shah B, Prince P, Gautam N, Beebe E, Pajerowski W, Cantu C, Meiseles H, Hughes D, Nador G, Sandin R, Hlavacek P, Li B, Meche A, Hyun Kim C, Perez Cruz I, Sumaya M, DiBonaventura M. Real-world treatment patterns and outcomes of patients with multiple myeloma initiating elranatamab: results from the ALTITUDE-1 and ALTITUDE-2 retrospective cohort studies. Future Oncol. 2026 May;22(11):1331-1340. doi: 10.1080/14796694.2026.2662504. Epub 2026 Apr 23.
PubMed 42021581Hebraud B, Charalampous C, Parrondo R, Chhabra S, Nagaraj M, DiBonaventura M, Duh MS, Bobbili PJ, Wang A, Frey-Koba S, Milce J, Levy M, Chafetz L, Faucher A, Johnson SMA, Hlavacek P, Cislo P, Hughes D, Nador G, Kumar SK. Comparison of Patient-Reported Outcomes for Elranatamab in MagnetisMM-3 Versus Real-World Physician Choice of Therapy for Triple-Class Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2026 Jun;26(6):e780-e792.e7. doi: 10.1016/j.clml.2026.03.014. Epub 2026 Mar 21.
PubMed 41968022Elmeliegy M, Soltantabar P, Hibma J, Ashman O, Wang D, Lon HK. Elranatamab Fixed Dosing: A Safe, Effective, and Convenient Dosing Approach. Target Oncol. 2025 Sep;20(5):821-831. doi: 10.1007/s11523-025-01170-4. Epub 2025 Aug 19.
PubMed 40830740Lon 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.
PubMed 40826257Gordan LN, Bensimon AG, Mu F, Kim N, Wu B, Lin D, Paner A, Fowler J, Marshall A, Van Sanden S, Ammann E, Goble J, Zhang X, Le HH, Min EE, Garrison LP Jr. Cost per responder for teclistamab and elranatamab in relapsed or refractory multiple myeloma in the United States. J Med Econ. 2025 Dec;28(1):910-920. doi: 10.1080/13696998.2025.2514909. Epub 2025 Jun 14.
PubMed 40495704Elmeliegy 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.
PubMed 40000533Iida S, Ito S, Yokoyama H, Ishida T, Nagai Y, Handa H, Ito S, Kamei Y, Nakamura M, Suzuki K. Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3. Jpn J Clin Oncol. 2024 Sep 4;54(9):991-1000. doi: 10.1093/jjco/hyae068.
PubMed 38794892Mol I, Hu Y, LeBlanc TW, Cappelleri JC, Chu H, Nador G, Aydin D, Schepart A, Hlavacek P. A matching-adjusted indirect comparison of the efficacy of elranatamab versus physician's choice of treatment in patients with triple-class exposed/refractory multiple myeloma. Curr Med Res Opin. 2024 Feb;40(2):199-207. doi: 10.1080/03007995.2023.2277850. Epub 2024 Jan 24.
PubMed 38078866Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, Rodriotaguez-Otero P, Martinez-Lopez J, Koehne G, Touzeau C, Jethava Y, Quach H, Depaus J, Yokoyama H, Gabayan AE, Stevens DA, Nooka AK, Manier S, Raje N, Iida S, Raab MS, Searle E, Leip E, Sullivan ST, Conte U, Elmeliegy M, Czibere A, Viqueira A, Mohty M. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023 Sep;29(9):2259-2267. doi: 10.1038/s41591-023-02528-9. Epub 2023 Aug 15.
PubMed 37582952