Groupe d'Etude en Oncologie du Quebec

Titre	A phase I, open label study to evaluate the safety, pharmacokinetic, pharmacodynamic and clinical activity of PF-06863135, a B-cell maturation antigen (BCMA) - CD3 bispecific antibody, as a single agent and in combination with immunomodulatory agents in patients with relapsed/refractory advanced multiple myeloma
Protocole ID	C1071001
ClinicalTrials.gov ID	NCT03269136
Type(s) de cancer	Myélome
Phase	Phase I
Stade	Récidivant/réfractaire (2ième ligne de traitement et plus)
Type étude	Clinique
Médicament	PF-06863135 seul et en association avec des agents immunomodulateurs
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dr Chaim Shustik Dr Michael Sebag
Coordonnateur(trice)	Nancy Renouf 514-934-1934 poste 35718
Statut	Actif en recrutement
Critètes d'éligibilité	Relapsed/refractory multiple myeloma Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody Performance Status of 0- 2 (unless due to bone pain) Adequate bone marrow, hematological, kidney and liver function Resolved acute effects of any prior therapy to baseline severity Not pregnant
Critètes d'exclusion	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 Current requirement for chronic blood product support

Groupe d'étude en oncologie du Québec