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

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

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.

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

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) of ABT-888.

Outcome Description:

Study follows a modified dose escalation scheme with a 3+3 design (3 to 6 patients per dose level or cohort). Only the ABT-888 dose will be escalated with a maximum dose of ABT-888 of 100 mg PO BID. If >1 out 6 patients at any dose level suffer dose limiting toxicity, then dose escalation is stopped, and this dose is declared as MTD. 3 additional patients will be entered at the next lowest dose level. The recommended phase 2 dose is defined as the dose level with ≤ 1 out of 6 patients experiencing DLTs at the highest dose level below the MTD.

Outcome Time Frame:

21 Day Cycle

Safety Issue:


Principal Investigator

Nizar J Bahlis, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Tom Baker Cancer Centre, University of Calgary


Canada: Health Canada

Study ID:




Start Date:

January 2012

Completion Date:

October 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell