Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193544
• Other study ID #: SCRI MM 03
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 21, 2009
• Start date: March 2002
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

Upon determination of eligibility, patients will be receive:

• Arsenic Trioxide + Thalidomide

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Arsenic Trioxide

• Thalidomide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	CTI BioPharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Overall survival
Secondary	Time to progression
Secondary	Overall toxicity