Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

NCT ID: NCT00193544

Last Updated: 2009-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2009-01-31

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

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Arsenic Trioxide

Intervention Type: DRUG

Thalidomide

Intervention Type: DRUG

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.

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

Sponsors

CTI BioPharma

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Principal Investigators

John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Other Identifiers

SCRI MM 03

Identifier Type: -

Identifier Source: org_study_id