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Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma

Upon determination of eligibility, patients will be receive:

- Arsenic Trioxide + Thalidomide

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

January 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell