NCT Number: NCT00193544
Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma
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
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
About this study
Upon determination of eligibility, patients will be receive:
- Arsenic Trioxide + Thalidomide
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
thalidomide
DrugPrimary outcomes
-
Overall response rate
Secondary outcomes
-
Overall survival
-
Time to progression
-
Overall toxicity
Sponsors and collaborators
Lead sponsor
SCRI Development Innovations, LLC
Other
Collaborators
- CTI BioPharma
Registry information
Official study title
Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma
Important dates
- Study start
- 2002
- Primary completion
- 2005
- Study completion
- 2009
- First posted
- Sep 19, 2005
- Registry last updated
- Jan 23, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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