Study of ABT-888 in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Refractory Myeloma

Official Title

Phase I Study of ABT-888 in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Refractory Myeloma

Summary:

The combination of PARP inhibitor (ABT-888) with a proteasome inhibitors (bortezomib) have demonstrated significant anti-myeloma effects in preclinical lab and animal studies. The goal of this phase I trial is to evaluate in patients with relapsed or refractory multiple myeloma the safety, toxicity profile and tolerability of ABT-888 (Veliparib) administered on a schedule including twice daily oral dosing for 14 days followed by 1 week rest in combination with standard dosing of Bortezomib.

Trial Description

Primary Outcome:

• Determine the maximum tolerated dose (MTD) of ABT-888.
• Identify the Dose Limiting Toxicities (DLT) of ABT-888

Secondary Outcome:

• Activity Objective - Preliminary assessment of the anti-tumour activity of ABT-888
• Exploratory Objective - Preliminary assessment of potential biomarkers
• Exploratory Objective - Determine in vivo the effect of ABT-888 on PARP inhibitors.
• Determine invivo the effects of Bortezomib on the plasma cells DNA genes expression and function

This is a dose-finding / dose escalation phase I trial of ABT-888 (Veliparib) in combination with Bortezomib and Dexamethasone in patients with relapsed or refractory multiple myeloma. ABT-888 is given orally (PO) twice daily (every 12 hours) for 14 days in a 21 days cycle. First dose to be given within 1 hour of Bortezomib on day 1. Planned starting dose is 20 mg PO every 12 hours. Starting dose escalation is planned until an MTD is reached.

View this trial on ClinicalTrials.gov