Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Arsenic Trioxide

Thalidomide

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be included in this study, you must meet the following criteria: Confirmed diagnosis of multiple Myeloma Received at least one previous chemotherapy regimen at most 3 previous Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens. Age at least 18 years years Able to perform activities of daily living with minimal assistance Life expectancy more than 3 months Adequate bone marrow, liver and kidney function Must give written informed consent in order to participate. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Women pregnant or lactating. Pre-existing moderate neuropathy Patients with significant underlying cardiac dysfunction Uncontrolled hypercalcemia Active serious infections not controlled by antibiotics History of grand mal seizures (other than infantile febrile seizures) Receiving other medications that prolong the QT interval. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Overall survival

Time to progression

Overall toxicity

Full Information

NCT ID

NCT00193544

First Posted

September 12, 2005

Last Updated

January 21, 2009

Sponsor

SCRI Development Innovations, LLC

Collaborators

CTI BioPharma

1. Study Identification

Unique Protocol Identification Number

NCT00193544

Brief Title

Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

Official Title

Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

CTI BioPharma

4. Oversight

5. Study Description

Brief Summary

In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy

Detailed Description

Upon determination of eligibility, patients will be receive: Arsenic Trioxide + Thalidomide

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Arsenic Trioxide

Intervention Type

Drug

Intervention Name(s)

Thalidomide

Primary Outcome Measure Information:

Title

Overall response rate

Secondary Outcome Measure Information:

Title

Overall survival

Title

Time to progression

Title

Overall toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: To be included in this study, you must meet the following criteria: Confirmed diagnosis of multiple Myeloma Received at least one previous chemotherapy regimen at most 3 previous Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens. Age at least 18 years years Able to perform activities of daily living with minimal assistance Life expectancy more than 3 months Adequate bone marrow, liver and kidney function Must give written informed consent in order to participate. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Women pregnant or lactating. Pre-existing moderate neuropathy Patients with significant underlying cardiac dysfunction Uncontrolled hypercalcemia Active serious infections not controlled by antibiotics History of grand mal seizures (other than infantile febrile seizures) Receiving other medications that prolong the QT interval. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D. Hainsworth, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial