Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

This study has been completed.

Study NCT00661544 Information provided by M.D. Anderson Cancer Center

First Received: April 15, 2008 Last Updated: May 21, 2009 History of Changes

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Conditions:	Multiple Myeloma Stem Cell Transplantation
Interventions:	Drug: Arsenic Trioxide Drug: Melphalan Drug: Ascorbic Acid

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 03/31/2004 through 08/02/2005. All pariticipants recruited at U.T. M.D. Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Arsenic Trioxide + Vitamin C + Melphalan	Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)

Participant Flow: Overall Study

	Arsenic Trioxide + Vitamin C + Melphalan
STARTED	48
COMPLETED	48
NOT COMPLETED	0

Baseline Characteristics

Reporting Groups

	Description
Arsenic Trioxide + Vitamin C + Melphalan	Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)

Baseline Measures

	Arsenic Trioxide + Vitamin C + Melphalan
Number of Participants [units: participants]	48
Age, Customized [units: years] Median ( Full Range )	54 ( 35 to 70 )
Gender [units: participants]
Female	23
Male	25
Region of Enrollment [units: participants]
United States	48