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PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
Trial Status: complete
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03269136.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
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.