Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Arsenic Trioxide Drug: Thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma |
- Overall response rate
- Overall survival
- Time to progression
- Overall toxicity
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2002 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Upon determination of eligibility, patients will be receive:
- Arsenic Trioxide + Thalidomide
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00193544 History of Changes |
| Other Study ID Numbers: | SCRI MM 03 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Thalidomide |
Arsenic trioxide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013