Arsenic Trioxide in Treating Patients With Multiple Myeloma | NCT00017433

Studies
Arsenic Trioxide in Treating Patients With Multiple Myeloma

NCT00017433

Sponsor

CTI BioPharma

Status

Terminated

Last Update Posted

Oct 6, 2020Actual

Enrollment

Not provided

Phase

Phase 2

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Interventions

arsenic trioxide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CDR0000068688	Registry Identifier	PDQ (Physician Data Query)

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001Actual

Primary Completion Date

Jan 2005Actual

Completion Date

Jan 2005Actual

First Submitted Date

Jun 6, 2001

First Submission Date that Met QC Criteria

Jan 7, 2004

First Posted Date

Jan 8, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2020

Last Update Posted Date

Oct 6, 2020Actual

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
arsenic trioxide	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Carolyn Paradise, MD	CTI BioPharma	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Clinic		La Jolla	California	92037	United States
Rocky Mountain Cancer Center

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D054219	Neoplasms, Plasma Cell

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001152	Arsenicals
D007287	Inorganic Chemicals
D010087	Oxides
D017601	Oxygen Compounds