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.
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.
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
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There are 33 Locations for this study
Encinitas California, 92024, United States
La Jolla California, 92037, United States
La Jolla California, 92037, United States
San Diego California, 92103, United States
Vista California, 92081, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60637, United States
Flossmoor Illinois, 60422, United States
Harvey Illinois, 60426, United States
New Lenox Illinois, 60451, United States
Orland Park Illinois, 60462, United States
Tinley Park Illinois, 60477, United States
Iowa City Iowa, 52242, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02114, United States
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10021, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Durham North Carolina, 27710, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Dallas Texas, 75246, United States
Calgary Alberta, T2N 2, Canada
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G2M, Canada
Montreal Quebec, H4A 3, Canada
Montreal Quebec, H4A3J, Canada
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