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

• Status: Completed
• Trial end date: 2015-02-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta; Alberta Health Services
• Collaborators: Abbott; Tom Baker Cancer Centre
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Veliparib

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