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Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III 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: NCT00017069
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : October 5, 2020
National Cancer Institute (NCI)
Information provided by:
CTI BioPharma

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: arsenic trioxide Drug: dexamethasone Phase 2

Detailed Description:


  • Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone.
  • Determine the rates of overall and relapse-free survival in patients treated with this regimen.
  • Determine the safety profile of this treatment regimen in these patients.

OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR.

Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : February 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of stage II or III multiple myeloma
  • Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy

    • No more than 3 prior cytotoxic regimens
    • No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation
  • History of disease progression after prior steroid antimyeloma therapy
  • No smoldering myeloma
  • Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma



  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


  • Absolute granulocyte count greater than 1,200/mm^3*
  • Platelet count greater than 75,000/mm^3*
  • Hemoglobin greater than 10 g/dL* NOTE: *Unless due to multiple myeloma


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 2 times ULN


  • Creatinine no greater than 1.5 times ULN


  • Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels
  • No significant underlying cardiac dysfunction
  • No conduction defects
  • No unstable angina
  • No congestive heart failure
  • No New York Heart Association class II-IV cardiac disease
  • No myocardial infarction within the past 6 months


  • No preexisting grade 2 or greater neurotoxicity/neuropathy
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No uncontrolled diabetes mellitus
  • No active serious infection uncontrolled by antibiotics
  • No history of grand mal seizures (other than infantile febrile seizures)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics
  • See Chemotherapy
  • At least 28 days since prior biologic therapy


  • See Disease Characteristics
  • At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • See Disease Characteristics


  • At least 28 days since prior radiotherapy except for focal radiation for symptom control


  • Not specified

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): NCT00017069

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United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
United States, California
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868-3849
Stockton Hematology Oncology Medical Group
Stockton, California, United States, 95204
United States, Colorado
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States, 80218
United States, Florida
Pasco Pinellas Cancer Center - Tarpon Springs
Tarpon Springs, Florida, United States, 34689
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Idaho
Mountain States Tumor Institute - Boise
Meridian, Idaho, United States, 83642
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
Texas Cancer Care
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
CTI BioPharma
National Cancer Institute (NCI)
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Study Chair: Scott C. Stromatt, MD CTI BioPharma
Layout table for additonal information Identifier: NCT00017069    
Other Study ID Numbers: CTI-1060
CDR0000068646 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Keywords provided by CTI BioPharma:
refractory multiple myeloma
stage II multiple myeloma
stage III 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
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