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Phase I/II Study of Arsenic Trioxide (Trisenox), Ascorbic Acid and Bortezomib Combination Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Phase 1/Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

Phase I/II Study of Arsenic Trioxide (Trisenox), Ascorbic Acid and Bortezomib Combination Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Despite the fact the high dose therapy and autologous transplant can prolong life in
patients with multiple myeloma (MM), in most studies there appears to be a continuously
declining event free survival following auto-transplant indicating that few patients will be
cured with this approach. A high percentage of patients the relapse in the post transplant
setting will not be candidate for additional chemotherapy. We therefore, are investigating
novel strategies for controlling their disease in the post transplant setting. The key
theoretical issue for this study is whether concomitant Trisenox would permit the use of
less toxic doses of Velcade, resulting in a less toxic but equally effective regimen.

Phase I of this study uses dose escalation to estimate the maximum tolerated dose of
Arsenic, Ascorbic Acid and Velcade. Phase II is a subsequent treatment phase using the
maximum tolerated dose from Phase I. In the absence of treatment delays due to adverse
events, treatment may continue for 6 cycles, plus two additional cycles if patient has
achieved a good response.

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

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

- 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

- 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

- 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%.

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

30 days post last dose of study drug

Safety Issue:


Principal Investigator

Cristina Gasparetto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

December 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Duke University Medical CenterDurham, North Carolina  27710