Multiple Myeloma Clinical Trial

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

Summary

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.

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Full Description

Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

103

Study ID:

NCT03269136

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 34 Locations for this study

See Locations Near You

UCSD Medical Center - Encinitas
Encinitas California, 92024, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
UC San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
UCSD Medical Center - Vista
Vista California, 92081, United States
Blood and Marrow Transplant Group of Georgia
Atlanta Georgia, 30342, United States
Northside Hospital
Atlanta Georgia, 30342, United States
UChicago Medicine - River East
Chicago Illinois, 60611, United States
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
Chicago Illinois, 60637, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor Illinois, 60422, United States
UChicago Medicine Ingalls Memorial
Harvey Illinois, 60426, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox Illinois, 60451, United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park Illinois, 60462, United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park Illinois, 60477, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center at Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center at Bergen
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center at Commack
Commack New York, 11725, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale New York, 11553, United States
Duke University Health System: Adult Bone Marrow Transplant Clinic
Durham North Carolina, 27705, United States
Duke Cancer Center
Durham North Carolina, 27710, United States
Duke University Hospital
Durham North Carolina, 27710, United States
Henry Joyce Cancer Center
Nashville Tennessee, 37232, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
Investigational Drug Services, Baylor University Medical Center
Dallas Texas, 75246, United States
Unit 57, Special Services Building
Calgary Alberta, T2N 2, Canada
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto Ontario, M5G2M, Canada
McGill University Health center
Montreal Quebec, H4A 3, Canada
MUHC, GLEN site
Montreal Quebec, H4A3J, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

103

Study ID:

NCT03269136

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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