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

NCT04649359 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 2

Started

2021-02-02

Last updated

2026-05-19

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Elranatamab (PF-06863135)

Elranatamab (PF-06863135): BCMA-CD3 bispecific antibody

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria — 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.

Trial sites (40)

Facility	City	Region
Beverly Hills Cancer Center	Beverly Hills	California
Chao Family Comprehensive Cancer Center and Ambulatory Care	Irvine	California
UCLA Hematology/Oncology Clinic	Los Angeles	California
UC Irvine Health - Chao Family Comprehensive Cancer Center	Orange	California
Baptist Hospital of Miami	Miami	Florida
Miami Cancer Institute	Miami	Florida
Emory University	Atlanta	Georgia
Winship Cancer Institute, Emory University	Atlanta	Georgia
Blood and Marrow Transplant Group of Georgia	Atlanta	Georgia
Northwestern Medical Group	Chicago	Illinois
Northwestern Memorial Hospital	Chicago	Illinois
Loyola University Chicago performing research at Loyola University Medical Center	Maywood	Illinois
Loyola University Medical Center	Maywood	Illinois
Norton Women's and Children's Hospital	Louisville	Kentucky
Ochsner Clinic Foundation	New Orleans	Louisiana
Regional Cancer Care Associates, LLC	Hackensack	New Jersey
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy	Long Island City	New York
Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York
Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York
St Francis Physician Services Inc	Greenville	South Carolina
Baylor Scott & White Research Institute	Dallas	Texas
St Vincent's Hospital (Melbourne)	Fitzroy	Victoria
The Alfred	Melbourne	Victoria
Epworth Healthcare	Richmond	Victoria
CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont	Montreal	Quebec
McGill University Health Centre - Glen Site	Montreal	Quebec
CHU de Lille - Hopital Claude Huriez	Lille	France
CHU de Nantes - Hôtel Dieu	Nantes	France
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique	Pierre-Bénite	France
CHU de Poitiers, Pôle Régional de Cancérologie	Poitiers	France
Universitätsklinikum Hamburg - Eppendorf	Hamburg	Germany
Nagoya City University Hospital	Nagoya	Aichi-ken
Gunma University Hospital	Maebashi	Gunma
Kobe City Medical Center General Hospital	Kobe	Hyōgo
Tohoku University Hospital	Sendai	Miyagi
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy	Bydgoszcz	Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu	Poznan	Poland
Clinica Universitaria de Navarra	Madrid	Spain
Hospital Universitario 12 de Octubre	Madrid	Spain
Hospital Universitario Doctor Peset	Valencia	Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04649359 on ClinicalTrials.gov ↗ ← All trials in the USA