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

NCT ID: NCT01495351

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-02-10

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-888/Bortezomib

Patients will be on a treatment schedule including twice daily oral dosing for 14 days followed by 1 week rest in combination with standard dosing of Bortezomib and Dexamethasone in a 21 days cycle for a total of 14 cycles.

Group Type EXPERIMENTAL

ABT-888/Bortezomib

Intervention Type DRUG

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.

Interventions

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ABT-888/Bortezomib

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of multiple myeloma.
* Measurable disease, according to the International Myeloma Working Group criteria.
* ECOG performance status 0, 1 or 2.

Exclusion Criteria

* Prior radiation, completed at least 4 weeks prior to registration, is permitted.
* Adequate marrow reserve, liver and renal function


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tom Baker Cancer Centre

OTHER

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nizar J Bahlis, M.D.

Role: STUDY_CHAIR

Tom Baker Cancer Centre, University of Calgary

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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E24055

Identifier Type: OTHER

Identifier Source: secondary_id

MM11-01

Identifier Type: -

Identifier Source: org_study_id