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Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00227682
Recruitment Status : Terminated (Terminated early due to funding suspension by grant sponsor.)
First Posted : September 28, 2005
Last Update Posted : May 28, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Dietary Supplement: ascorbic acid Drug: arsenic trioxide Drug: dexamethasone Drug: thalidomide Phase 2

Detailed Description:


  • Determine the safety and side effects of arsenic trioxide administered in combination with thalidomide, dexamethasone, and ascorbic acid in patients with relapsed or refractory multiple myeloma.
  • Determine, preliminarily, the anticancer effects of this regimen in these patients.
  • Determine the duration of anticancer effects in patients treated with this regimen.
  • Determine the effect of this regimen on bone and immune function in these patients.

OUTLINE: Patients receive arsenic trioxide IV continuously and oral ascorbic acid once daily on days 1-5 in week 1 and twice weekly in weeks 2-12 and oral thalidomide once daily in weeks 1-14. Treatment with arsenic trioxide, ascorbic acid, and thalidomide repeats every 14 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone once daily on days 1-4. Treatment with dexamethasone repeats every 28 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
Study Start Date : June 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Arm Intervention/treatment
Experimental: Arsenic Trioxide
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
Dietary Supplement: ascorbic acid
Drug: arsenic trioxide
Drug: dexamethasone
Drug: thalidomide

Primary Outcome Measures :
  1. Response rate (complete response, partial response, and minimal response) as measured by bone marrow aspirate, biopsy, cytogenetic analysis, serum, urine, and immunofixation skeletal survey at 6 months and end of study treatment

Secondary Outcome Measures :
  1. Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of multiple myeloma (MM)

    • Relapsed or refractory disease
  • Monoclonal immunoglobulin spike by serum electrophoresis of ≥ 1 gm/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
  • Has received ≥ 2 prior treatment regimens for MM
  • None of the following are allowed:

    • Non-secretory MM
    • Plasma cell leukemia
    • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome



  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if the bone marrow is extensively infiltrated)
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 1,000/mm^3


  • AST and ALT < 3.0 times upper limit of normal (ULN)
  • Bilirubin < 2.0 times ULN


  • Not specified


  • No cardiac disease, including any of the following conditions:

    • History of recurrent supraventricular arrhythmia
    • History of sustained ventricular tachycardia
    • History of second or third degree AV block
    • History of left bundle branch block
    • Cardiomyopathy with LVEF < 40%
    • Uncontrolled ischemic heart disease
  • No myocardial infarction within the past 6 months
  • No prolonged QT interval > 500 ms


  • Not pregnant or nursing
  • Negative pregnancy test
  • No HIV positivity
  • No neuropathy > grade 3
  • Potassium ≥ 4 mEq/L
  • Magnesium ≥ 1.8 mg/dL


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 30 days since prior investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00227682

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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Aleksandra Simic, MD OHSU Knight Cancer Institute
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Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00227682    
Other Study ID Numbers: CDR0000443708
OHSU-1277 ( Other Identifier: OHSU IRB )
OHSU-HEM-03100-L ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: June 2010
Keywords provided by OHSU Knight Cancer Institute:
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Ascorbic Acid
Arsenic Trioxide
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents