Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193544
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 23, 2009
CTI BioPharma
Information provided by:
SCRI Development Innovations, LLC

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Arsenic Trioxide Drug: Thalidomide Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Arsenic Trioxide + Thalidomide

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma
Study Start Date : March 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : January 2009

Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Overall survival
  2. Time to progression
  3. Overall toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193544

Sponsors and Collaborators
SCRI Development Innovations, LLC
CTI BioPharma
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC Identifier: NCT00193544     History of Changes
Other Study ID Numbers: SCRI MM 03
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 23, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Arsenic trioxide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents