Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
CTI BioPharma
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193544
First received: September 12, 2005
Last updated: January 21, 2009
Last verified: January 2009
  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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193544

Sponsors and Collaborators
SCRI Development Innovations, LLC
CTI BioPharma
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  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 September 11, 2014