Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI, Pharmaceutical / Industry	CTI-1060 MSKCC-01012, NCI-G01-1951, NCT00017069

Objectives

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

Entry 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

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute granulocyte count greater than 1,200/mm³*
• Platelet count greater than 75,000/mm³*
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Cell Therapeutics, Incorporated

Scott Stromatt, MD, Protocol chair		Ph: 206-272-4355

Registry Information
Official Title		CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
Trial Start Date		2001-02-13
Registered in ClinicalTrials.gov		NCT00017069
Date Submitted to PDQ		2001-04-03
Information Last Verified		2004-04-27
NCI Grant/Contract Number		P30-CA08748

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