Overview

Trisenox, Ascorbic Acid and Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma

Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
This is a phase I dose escalation study to estimate the maximum tolerated dose (MTD) of the novel combination of Arsenic, Ascorbic Acid and Velcade, followed by a phase II study conducted using the MTD estimated from the phase I portion.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
Cephalon
Treatments:
Arsenic Trioxide
Ascorbic Acid
Bortezomib
Criteria
Inclusion Criteria:

- Diagnosis of relapsed/refractory multiple myeloma.

- Patients must have measurable disease, defined as localized plasmacytoma, detectable
M-spike by serum protein electrophoresis (SPEP) and/or urine protein electrophoresis
(UPEP), or free light chain assay, bone lytic lesions and/or bone marrow infiltration
with atypical plasma-cells.

- Patients must be at least four weeks since their prior therapy. Patients will not be
excluded because of any prior regimen they have received as long as they meet other
requirements.

- Adequate organ function, patients with elevated creatinine due to myeloma are not
excluded

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Serum potassium greater than 4.0 milliequivalent (mEq)/dL and serum magnesium greater
than 1.8 mg/dL. If these electrolytes are below the specified limits on the baseline
laboratory tests, supplemental electrolytes should be administered to bring the serum
concentrations to these levels before administering arsenic trioxide.

Exclusion Criteria:

- Patients may not be receiving any other investigational agents.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Bortezomib, Trisenox, Ascorbic acid, or other agents used in the study.

- Corrected QT interval (QTc) interval greater than 460 msec in the presence of serum
potassium greater than or equal to 4.0 mEq/L and magnesium greater than or equal to
1.8 mg/dL, or underlying conduction disease that prevents measurement of the QTc
interval.

- History of ventricular tachycardia or any cardiac arrhythmia requiring the placement
of an automated intraventricular cardiac defibrillator or therapy with class I or
class II antiarrhythmic drug.

- Ejection fraction (EF) by multigated acquisition (MUGA) scan less than 35%.