Study of ABT-888 in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Refractory Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ABT-888/Bortezomib
Type: Drug
Overall Status
Recruiting
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Confirmed diagnosis of multiple myeloma.

- Measurable disease, according to the International Myeloma Working Group criteria.

- ECOG performance status 0, 1 or 2.

- Patients must have received prior treatment for MM and have relapsed or progressed on prior therapy; no limit on number of prior treatment regimens, but prior treatment must be completed 2 weeks prior to registration. Prior exposure to Bortezomib is not an exclusion criteria as long as patients did not progress or relapse while receiving or within 3 months of completing trt with bortezomib

- Prior radiation, completed at least 4 weeks prior to registration, is permitted.

- Adequate marrow reserve, liver and renal function

Exclusion Criteria:

- patients with a history of other malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, prostate cancer with stable PSA for > 3 years, or other solid tumours curatively treated with no evidence of disease for > 5 years.

- Patients with preexisting grade 2 (or higher) sensory neuropathy or grade 1 sensory neuropathy with neuropathic pain.

- Pregnant or lactating women

- Patients receiving concurrent treatment with other anti-cancer therapy any other investigational agents.

- Active or uncontrolled infections

- Patient with known documented congenital or acquired risk factor for thromboembolic event

- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive
Location
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Start Date
January 2012
Completion Date
October 2013
Sponsors
Alberta Health Services
Source
AHS Cancer Control Alberta
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page