PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Key facts

Study ID

NCT03269136

Run by

Pfizer

People needed

101

Starts

2017-11-29

Expected to finish

2024-01-19

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed/refractory multiple myeloma
• 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

You may not qualify if…

• Recent history of other malignancies
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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