A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
NCT ID: NCT05014412
Last Updated: 2025-10-15
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
86 participants
INTERVENTIONAL
2021-10-07
2025-10-30
Brief Summary
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Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1
Evaluation of step-up priming dosing
Elranatamab
BCMA-CD3 bispecific antibody
Part 2A
Dose determination
Elranatamab
BCMA-CD3 bispecific antibody
Part 2B
Dose expansion
Elranatamab
BCMA-CD3 bispecific antibody
Part 2C
To explore higher dose intensity
Elranatamab
BCMA-CD3 bispecific antibody
Interventions
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Elranatamab
BCMA-CD3 bispecific antibody
Eligibility Criteria
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Inclusion Criteria
* 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
* ECOG performance status ≤1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
* Not pregnant and willing to use contraception
Exclusion Criteria
* Active Plasma cell leukemia
* POEMS syndrome
* Amyloidosis
* Waldenström's macroglobulinemia
* Known active CNS involvement or clinical signs of myelomatous meningeal involvement
* Stem cell transplant within 12 weeks prior to enrollment or active GVHD
* 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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
* Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
* Live attenuated vaccine within 4 weeks of the first dose
* 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)
* Known or suspected hypersensitivity to the study intervention, or any of its excipients
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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Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care & Hematology - Fort Collins
Fort Collins, Colorado, United States
Poudre Valley Health System (PVHS)
Fort Collins, Colorado, United States
UCHealth Cancer Care & Hematology - Greeley
Greeley, Colorado, United States
UCHealth Cancer Care & Hematology - Loveland
Loveland, Colorado, United States
UF Health Shands Cancer Hospital
Gainesville, Florida, United States
UF Health Shands Hospital Pharmacy Investigational Drug Service - Main
Gainesville, Florida, United States
UF Health Shands Hospital
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
East Jefferson General Hospital Bone Marrow Transplant Clinic
Metairie, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
The Regents of the University of Michigan
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
MSK Basking Ridge
Basking Ridge, New Jersey, United States
MSK Monmouth
Middletown, New Jersey, United States
MSK Bergen
Montvale, New Jersey, United States
MSK Commack
Commack, New York, United States
MSK Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MSK Nassau
Uniondale, New York, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Oncology - South Austin
Austin, Texas, United States
Blood Cancer and Stem Cell Transplant Clinic
San Antonio, Texas, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, United States
Methodist Hospital Investigational Pharmacy
San Antonio, Texas, United States
Methodist Plaza Clinical Trials Office
San Antonio, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust NIHR
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, , United Kingdom
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.
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.
www.MultipleMyelomaMM9Study.com
Other Identifiers
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MagnetisMM-9
Identifier Type: OTHER
Identifier Source: secondary_id
C1071009
Identifier Type: -
Identifier Source: org_study_id
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