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Clinical Trials in Spain / NCT04649359
Active, not recruiting Phase 2

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 Spain 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
No
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)

FacilityCityRegionStatus
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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Other trials for the same condition

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting
Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma Active, not recruiting
A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma Recruiting
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 Spain