A Multicenter Phase 1/2b of the Bruton’s Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination with Carfilzomib (Kyprolis) in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma

ID Number 13-1980

Principal Investigator(s)
Ajai Chari

Department(s) or Division(s)
Hematology and Medical Oncology

Description

Ibrutinib is a type of drug called a “kinase inhibitor”. “Kinases” are proteins inside cells that help cells live and grow. The specific kinase inhibited or “blocked” by ibrutinib is believed to help blood cancer cells live and grow. By inhibiting the activity of this specific kinase, it is possible that the ibrutinib may kill the cancer cells or stop them from growing. Ibrutinib is an investigational drug that is not approved for sale in any country
Carfilzomib is a proteasome inhibitor, proteasomes are enzymes in cells that play a role in the cell growth and regulation by controlling the breakdown of enzymes. Carfilzomib blocks the activity of proteasomes and disrupts the processes related to growth and survival of cancer cells. Carfilzomib is approved by the FDA for the treatment of relapsed and refractory multiple myeloma.


In this study, patients with multiple myeloma, who have previously received treatment and have relapsed or relapsed and refractory disease will be eligible to participate. The study has two parts:
• Phase 1 tests different doses of ibrutinib and carfilzomib together to study what dose to use in Phase 2b
• Phase 2b will study the effects of the treatment. All subjects will receive carfilzomib, only half of the subjects will receive ibrutinib, to test if there is a benefit to adding ibrutinib to carfilzomib treatment
You are being asked to participate in Phase 1, to find out:
• What doses of the ibrutinib and carfilzomib are safe to be used in Phase 2b
• If and how well the study treatment controls your multiple myeloma
• To evaluate whether special bone marrow and blood tests can predict how effective the treatment with ibrutinib and carfilzomib may be



Contact Information
Lisa La
(212) 241-8615
(212) 824-7309

Recruiting Patients: Yes