PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
NCT ID: NCT03269136
Last Updated: 2025-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
101 participants
INTERVENTIONAL
2017-11-29
2024-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-06863135
BCMA-CD3 bispecific antibody
PF-06863135 monotherapy IV or SC
PF-06863135 will be administered intravenously or subcutaneously.
PF-06863135 + dexamethasone
BCMA-CD3 bispecific antibody + dexamethasone
PF-06863135 + dexamethasone
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
PF-06863135 + lenalidomide
BCMA-CD3 bispecific antibody + lenalidomide
PF-06863135 + lenalidomide
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
PF-06863135 + pomalidomide
BCMA-CD3 bispecific antibody + pomalidomide
PF-06863135 + pomalidomide
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
Interventions
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PF-06863135 monotherapy IV or SC
PF-06863135 will be administered intravenously or subcutaneously.
PF-06863135 + dexamethasone
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
PF-06863135 + lenalidomide
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
PF-06863135 + pomalidomide
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
* Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
* Adequate bone marrow, hematological, kidney and liver function
* Resolved acute effects of any prior therapy to baseline severity
* Not pregnant
Exclusion Criteria
* History of active autoimmune disorders
* Any form of primary immunodeficiency
* Active and clinically significant bacterial, fungal, or viral infection
* Evidence of active mucosal or internal bleeding
* History of severe immune-mediated adverse event with prior immunomodulatory treatment
* Major surgery within 4 weeks of study treatment start
* Radiation therapy within 2 weeks of study treatment start
* History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
* Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
* Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
* Requirement for systemic immune suppressive medication except as permitted in the protocol
* Current requirement for chronic blood product support
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UCSD Medical Center - Encinitas
Encinitas, California, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
UCSD Medical Center - Vista
Vista, California, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
UChicago Medicine - River East
Chicago, Illinois, United States
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, United States
UChicago Medicine Ingalls Memorial
Harvey, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale, New York, United States
Duke University Health System: Adult Bone Marrow Transplant Clinic
Durham, North Carolina, United States
Duke Cancer Center
Durham, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Henry Joyce Cancer Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Investigational Drug Services, Baylor University Medical Center
Dallas, Texas, United States
Unit 57, Special Services Building
Calgary, Alberta, Canada
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
MUHC, GLEN site
Montreal, Quebec, Canada
Countries
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References
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Lon 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.
Elmeliegy 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.
Bahlis NJ, Costello CL, Raje NS, Levy MY, Dholaria B, Solh M, Tomasson MH, Damore MA, Jiang S, Basu C, Skoura A, Chan EM, Trudel S, Jakubowiak A, Gasparetto C, Chu MP, Dalovisio A, Sebag M, Lesokhin AM. Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. Nat Med. 2023 Oct;29(10):2570-2576. doi: 10.1038/s41591-023-02589-w. Epub 2023 Oct 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2019-000822-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C1071001
Identifier Type: -
Identifier Source: org_study_id
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