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Phase II Study of Arsenic Trioxide in Patients With Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II Study of Arsenic Trioxide in Patients With Multiple Myeloma

OBJECTIVES: I. Determine the response rate of patients with relapsed or refractory stage II
or III multiple myeloma treated with arsenic trioxide. II. Determine the overall and
relapse-free survival rates of patients treated with this drug. III. Determine the safety
profile of this drug in these patients.

OUTLINE: Patients receive arsenic trioxide IV on days 1-5 and 8-12. Treatment repeats every
4 weeks for up to 6 courses. Patients are followed at 4 weeks after the last treatment dose.

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma Stage II or III (Durie-Salmon)
Relapsed or refractory to conventional therapy No monoclonal gammopathy or indolent or
smoldering myeloma Measurable disease by serum and urine M protein and/or plasmacytoma

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life
expectancy: 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet
count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less
than 2 times upper limit of normal (ULN) SGOT/SGPT less than 2 times ULN Renal: Creatinine
no greater than 2.5 mg/dL Cardiovascular: Absolute QT interval less than 460 msec in the
presence of normal potassium and magnesium levels

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 28 days since prior biologic therapy
Chemotherapy: No more than 3 prior chemotherapy regimens, including no more than 2
cytotoxic regimens AND 1 high-dose cytotoxic regimen as part of stem cell transplantation
Endocrine therapy: At least 28 days since prior endocrine therapy Radiotherapy: At least
28 days since prior radiotherapy (except for focal radiotherapy for symptom control)
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Carolyn Paradise, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cell Therapeutics


United States: Federal Government

Study ID:




Start Date:

January 2001

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Swedish Cancer Institute Seattle, Washington  98104
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Scripps Clinic La Jolla, California  92037
University of Illinois at Chicago Chicago, Illinois  60612
Rocky Mountain Cancer Center Denver, Colorado  80218
Georgia Cancer Specialist Marietta, Georgia  30060