A Phase IB/IIA Study of ABT-888 in Combination with Bendamustine with or without Rituximab in Patients with Lymphoma, Multiple Myeloma, and Solid Tumors

Protocol
10-174
Full Title
A Phase 1b/2a Study of ABT-888 in Combination with Bendamustine +/- Rituximab In Lymphoma, Multiple Myeloma and Solid Tumors (NCI Protocol# 8818)
Phase
I/II
Purpose

Bendamustine is an anticancer drug approved to treat chronic lymphocytic leukemia and slow-growing non-Hodgkin lymphoma. It works by damaging a cancer cell’s DNA. However, the body has proteins that try to repair the damaged DNA.

ABT-888 is an investigational drug called a PARP inhibitor. It may inhibit the ability of the proteins to repair the DNA, thereby allowing bendamustine to exert its cancer-killing activity and resulting in more cancer shrinkage or slower cancer growth than using bendamustine alone. It is a pill that is taken orally (by mouth).

In this study, researchers want to find the optimal dose of ABT-888 to give with bendamustine in patients with lymphoma, multiple myeloma, and solid tumors that have continued to grow despite prior therapy. In a later part of the study, patients with lymphoma will also receive rituximab, which enhances the effects of bendamustine; however, it is not known if rituximab will enhance the effects of bendamustine and ABT-888 when they are given together.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have lymphoma, multiple myeloma, or a solid tumor that has continued to grow despite prior therapy.
  • At least 4 weeks must have passed since completion of prior chemotherapy or radiation therapy and 3 months since immunotherapy or radioimmunotherapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.

Disease(s)
Hematology: Multiple Myeloma
Lymphoma
Locations