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
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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

Outcome Measures

1. Primary:

Response Rate [ 3, 6 and 12 months ]

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Response Rate
Measure Description	Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.
Time Frame	3, 6 and 12 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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)

Measured Values

	Arsenic Trioxide + Vitamin C + Melphalan
Number of Participants Analyzed [units: participants]	48
Response Rate [units: Participants]
Complete Response	11
Overall Response (Complete + Partial Response)	36

No statistical analysis provided for Response Rate

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Muzaffar H. Qazilbash, MD / Associate Professor
Organization: U.T. M.D. Anderson Cancer Center
phone: 713-745-3458

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Muzaffar H. Qazilbash, MD/Associate Professor )
Study ID Numbers:	2003-0603
Study First Received:	April 15, 2008
Results First Received:	March 13, 2009
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00661544 History of Changes
Health Authority:	United States: Institutional Review Board