Multiple Myeloma Clinical Trial
Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
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.
Full Description
OBJECTIVES:
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
Over 18
Performance status:
Karnofsky 70-100%
Life expectancy:
At least 3 months
Hematopoietic:
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
Hepatic:
Bilirubin no greater than 2 times upper limit of normal (ULN)
SGOT and SGPT no greater than 2 times ULN
Renal:
Creatinine no greater than 1.5 times ULN
Cardiovascular:
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
Other:
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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
See Chemotherapy
At least 28 days since prior biologic therapy
Chemotherapy:
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
Radiotherapy:
At least 28 days since prior radiotherapy except for focal radiation for symptom control
Surgery:
Not specified
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 10 Locations for this study
Tucson Arizona, 85712, United States
Springdale Arkansas, 72764, United States
Orange California, 92868, United States
Stockton California, 95204, United States
Denver Colorado, 80218, United States
Tarpon Springs Florida, 34689, United States
Atlanta Georgia, 30322, United States
Meridian Idaho, 83642, United States
New York New York, 10021, United States
Fort Worth Texas, 76104, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.