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

NCT ID: NCT00017069

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2005-01-31

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.

Detailed 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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

arsenic trioxide

Intervention Type: DRUG

dexamethasone

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

CTI BioPharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

Scott C. Stromatt, MD

Role: STUDY_CHAIR

CTI BioPharma

Locations

Arizona Clinical Research Center

Tucson, Arizona, United States

Highlands Oncology Group - Springdale

Springdale, Arkansas, United States

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Stockton Hematology Oncology Medical Group

Stockton, California, United States

Rocky Mountain Cancer Centers - Midtown

Denver, Colorado, United States

Pasco Pinellas Cancer Center - Tarpon Springs

Tarpon Springs, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Mountain States Tumor Institute - Boise

Meridian, Idaho, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Texas Cancer Care

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

CDR0000068646

Identifier Type: REGISTRY

Identifier Source: secondary_id

MSKCC-01012

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1951

Identifier Type: -

Identifier Source: secondary_id

CTI-1060

Identifier Type: -

Identifier Source: org_study_id