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Pfizer launches early trial of PF-07994525 for Hard-to-Treat myeloma
NCT ID NCT07426757
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This early-stage study tests a new drug, PF-07994525, in about 120 adults with advanced multiple myeloma that has come back or not responded to treatment. The main goals are to check the drug's safety, find the right dose, and see if it can shrink tumors. The study has two parts: first, finding a safe dose, then testing that dose in more people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent. * Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014) Measurable disease based on IMWG criteria as defined by at least 1 of the following: 1. Serum M-protein \>0.5 g/dL by serum protein electrophoresis (SPEP) 2. Urinary M-protein excretion \>200 mg/24 hours by urine protein electrophoresis (UPEP) 3. Serum immunoglobulin Free Light Chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65) * Participants must be refractory to, or intolerant to, all established therapies known to provide clinical benefit in multiple myeloma that are an appropriate therapeutic option, in the judgement of the investigator. A minimum of 3 prior lines of therapy are required. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Exclusion Criteria: * Active plasma cell leukemia, Smoldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome. * Autologous stem cell transplant within 12 weeks prior to enrollment or active Graft-versus-host disease (GVHD). * Active or suspected cerebral/meningeal disease related to the underlying malignancy. * Any active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), known HIV or AIDS related illness, unless deemed not clinically significant by the investigator (eg, onychomycosis).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
19 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arthur J.E. Child Comprehensive Cancer Centre
RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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Emory University Hospital Midtown
RECRUITINGAtlanta, Georgia, 30308, United States
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute - Pharmacy
RECRUITINGNashville, Tennessee, 37203, United States
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Sylvester Comprehensive Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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Sylvester Comprehensive Cancer Center - Coral Springs
RECRUITINGCoral Springs, Florida, 33065, United States
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Sylvester Comprehensive Cancer Center - Hollywood
RECRUITINGHollywood, Florida, 33021, United States
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Sylvester Comprehensive Cancer Center - Plantation
RECRUITINGPlantation, Florida, 33324, United States
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Sylvester Comprehensive Cancer Center - Sole Mia
RECRUITINGNorth Miami, Florida, 33181, United States
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Sylvester Comprehensive Cancer Center- Doral
RECRUITINGDoral, Florida, 33166, United States
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Sylvester Comprehensive Cancer Center- Kendall
RECRUITINGMiami, Florida, 33176, United States
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Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
RECRUITINGCoral Gables, Florida, 33146, United States
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TriStar Centennial Medical center
RECRUITINGNashville, Tennessee, 37203, United States
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Tristar BMT
RECRUITINGNashville, Tennessee, 37203, United States
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University Health Network- Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G2M9, Canada
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University of Miami Hospital and Clinics
RECRUITINGMiami, Florida, 33136, United States
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University of Miami Hospital and Clinics - Deerfield Beach
RECRUITINGDeerfield Beach, Florida, 33442, United States
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Winship Cancer Institute, Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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