Multiple Myeloma Clinical Trial

Arsenic Trioxide in Treating Patients With Multiple Myeloma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

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

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Study ID:

NCT00017433

Recruitment Status:

Terminated

Sponsor:

CTI BioPharma

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 6 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Study ID:

NCT00017433

Recruitment Status:

Terminated

Sponsor:


CTI BioPharma

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider