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

CompletedPhase 1

Sponsor: Pfizer

Conditions: Multiple Myeloma

Interventions: PF-06863135 monotherapy IV or SC, PF-06863135 + dexamethasone, PF-06863135 + lenalidomide, PF-06863135 + pomalidomide

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (37)

Encinitas, California, United States
La Jolla, California, United States
La Jolla, California, United States
San Diego, California, United States
Vista, California, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Flossmoor, Illinois, United States
Harvey, Illinois, United States
New Lenox, Illinois, United States
Orland Park, Illinois, United States
Tinley Park, Illinois, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
New York, New York, United States
Uniondale, New York, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Nashville, Tennessee, United States
+ 7 more on CT.gov