Status:
COMPLETED
Study of ABT-888 in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Refractory Myeloma
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Tom Baker Cancer Centre
Abbott
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 give...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01495351
Start Date
October 1 2011
End Date
February 10 2015
Last Update
September 25 2017
Active Locations (1)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2