NCT00017433

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2001

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 8, 2004

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

4 years

First QC Date

June 6, 2001

Last Update Submit

October 2, 2020

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

arsenic trioxideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Georgia Cancer Specialist

Marietta, Georgia, 30060, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Carolyn Paradise, MD

    CTI BioPharma

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 8, 2004

Study Start

January 1, 2001

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

US(6)