Clinical Trial for Multiple Myeloma.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Multiple Myeloma

Sex

Male or Female

Age

18+ years

Healthy participants

Visit ClinicalTrials.gov for more information

Eligibility criteria

Inclusion criteria

Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL.
- Urinary M-protein excretion ≥200 mg/24 hours.
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
Prior anti-multiple myeloma therapy including treatment with lenalidomide.
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.
Plasma cell leukemia.
Amyloidosis.
POEMS Syndrome.
Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
Previous treatment with a BCMA-directed therapy.
Live attenuated vaccine within 4 weeks of the first dose of study intervention.
Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Study overview

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.

Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab.

People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.

Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.

All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

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Miles

0500

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31 sites found

Akita University Hospital

Akita, Japan, 010-8543

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Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, Limousin, France, 87042

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Chongqing University Cancer Hospital

Chongqing, China, 400030

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Clinica Universidad de Navarra

Pamplona, Navarre, Spain, 31008

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Fakultni Nemocnice Plzen

Plzen - Lochotin, Plzeň Region, Czechia, 304 60

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Fakultni poliklinika

Prague, Praha 2, Czechia, 120 00

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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy, 20122

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

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Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

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Hospital Universitario La Princesa

Madrid, Spain, 28006

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Hôpital Saint Antoine

Paris, France, 75571

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Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain, 08908

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Institute of hematology&blood disease hospital

Tianjin, Tianjin Municipality, China, 301636

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Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, United States, 10021

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Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States, 10065

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Nagasaki University Hospital

Nagasaki, Japan, 852-8501

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Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510515

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Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China, 210008

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National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan, 860-0008

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Pindara Private Hospital

Benowa, Queensland, Australia, 4217

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QScan Radiology Clinics

Clayfield, Queensland, Australia, 4011

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Saskatoon Cancer Center

Saskatoon, Saskatchewan, Canada, S7N4H4

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Slade Pharmacy

Richmond, Victoria, Australia, 3121

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510555

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Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida, United States, 33180

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Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida, United States, 33065

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Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida, United States, 33021

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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

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University of Miami Hospital and Clinics

Miami, Florida, United States, 33136

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University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, United States, 33442

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Universitätsklinikum rechts der Isar, Technische Universität München (TUM)

München, Germany, 81675

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Join PfizerConnect

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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