Status:
COMPLETED
Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
CTI BioPharma
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Al...
Detailed Description
Upon determination of eligibility, patients will be receive: * Arsenic Trioxide + Thalidomide
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00193544
Start Date
March 1 2002
End Date
January 1 2009
Last Update
January 23 2009
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