A Multicenter Phase 1/2b Study 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

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with relapsed or relapsed and refractory Multiple Myeloma. The study is evaluating an experimental drug called Ibrutinib (PCI-32765), in combination with Carfilzomib, which is currently FDA approved for relapsed and refractory multiple myeloma.

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. This investigational drug being tested and 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.

The study has 2 parts (participants will be enrolled in part 1 at this time).

Part 1 tests different doses of ibrutinib and carfilzomib together to study what dose to use in part 2. Part 2 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.

Participants will take ibrutinib daily on every day of 28 day cycles, beginning on cycle 1 day 8. Participants will continue on study treatment for as long as they are responding to therapy and not experiencing unacceptable side effects.

Key eligibility:

  • Men and women age 18 and older
  • Multiple Myeloma
  • Relapsed/refractory after at least 2 lines of standard therapy including:
       - bortezomib (Velcade) and an immunomodulator drug
  • Detailed eligibility reviewed when you contact the study team 

Contact:
Linda Tegnestam, R.N.
Email: lit2011@med.cornell.edu
Phone: (212) 746-1480

Kathleen Pogonowski, R.N.
Email: kap9111@med.cornell.edu 
Phone: (212) 746-6738

Disease Status and/or Stage

Relapsed or Refractory Multiple Myeloma

Sponsor

Pharmacyclics

Principal Investigator

Ruben Niesvizky, M.D.

Protocol ID

WCMC IRB # 1311014525


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Contact Us

For general inquiries, or if you need assistance finding a study, please e-mail:
Erica Bersin
Manager, Subject Recruitment & Communications
(646) 962-8232
erb3001@med.cornell.edu
jcto.weill.cornell.edu

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