Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

187

Study ID:

NCT04649359

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 65 Locations for this study

See Locations Near You

Beverly Hills Cancer Center
Beverly Hills California, 90211, United States
UCLA Hematology/Oncology Clinic
Los Angeles California, 90095, United States
UCLA Ronald Reagan Medical Center
Los Angeles California, 90095, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Baptist Hospital of Miami
Miami Florida, 33176, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Winship Cancer Institute @ Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Blood and Marrow Transplant Group of Georgia
Atlanta Georgia, 30342, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Northwestern Medical Group
Chicago Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Loyola University Chicago performing research at Loyola University Medical Center
Maywood Illinois, 60153, United States
Indiana Blood and Marrow Transplantation-Administrative Offices
Indianapolis Indiana, 46237, United States
Indiana Blood and Marrow Transplantation-Clinic
Indianapolis Indiana, 46237, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Norton Cancer Institute, St. Matthews Campus
Louisville Kentucky, 40207, United States
Norton Women's and Children's Hospital
Louisville Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York New York, 10021, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York New York, 10021, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York New York, 10065, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
St. Francis Hospital
Greenville South Carolina, 29601, United States
Saint Francis Hospital Cancer Center
Greenville South Carolina, 29607, United States
St Francis Eastside
Greenville South Carolina, 29615, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
Epworth Healthcare
East Melbourne Victoria, 3002, Australia
St Vincent's Hospital (Melbourne)
Fitzroy Victoria, 3065, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
The Alfred
Melbourne Victoria, 3004, Australia
Epworth Healthcare
Richmond Victoria, 3050, Australia
ZNA-Middelheim
Antwerpen , 2020, Belgium
ZNA Stuivenberg
Antwerpen , 2060, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
CHU UCL Namur site Godinne
Yvoir , 5530, Belgium
Foothills Medical Centre
Calgary Alberta, T2N 2, Canada
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
McGill University Health Centre - Glen Site
Montreal Quebec, H4A 3, Canada
CHU de Lille - Hopital Claude Huriez
Lille , 59037, France
CHU de Nantes - Hôtel Dieu
Nantes Cedex 1 , 44093, France
Hôpital Saint-Antoine
Paris Cedex 12 , 75571, France
Hopital Saint-Louis
Paris , 75010, France
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
Pierre Benite Cedex , 69495, France
CHU de Poitiers, Pôle Régional de Cancérologie
Poitiers Cedex , 86021, France
Klinikum Chemnitz gGmbH
Chemnitz , 09113, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg , 20246, Germany
Universitätsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitätsklinik Schleswig-Holstein
Kiel , 24105, Germany
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan
Gunma University Hospital
Maebashi Gunma, 371-8, Japan
Kobe City Medical Center General Hospital
Kobe-city Hyogo, 650-0, Japan
Iwate Medical University Hospital
Yahaba-cho, Shiwa-gun Iwate, 028-3, Japan
Tohoku University Hospital
Sendai Miyagi, 980-8, Japan
Japanese Red Cross Medical Center
Shibuya-ku Tokyo, 150-8, Japan
Yamagata University Hospital
Yamagata , 990-9, Japan
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz , 85-16, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan , 60-56, Poland
Uniwersytecki Szpital Kliniczny im.Jana Mikulicza -Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela A Coruna, 15706, Spain
Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Clinica Universitaria de Navarra
Pamplona Navarra, 31008, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Clinica Universitaria de Navarra
Madrid , 28027, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Doctor Peset
Valencia , 46017, Spain
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

187

Study ID:

NCT04649359

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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