Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients

This study has been completed.

Study NCT00469209 Information provided by M.D. Anderson Cancer Center

First Received on May 3, 2007. Last Updated on June 13, 2011 History of Changes

Results First Received: March 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Myeloma
Interventions:	Drug: Trisenox (Arsenic Trioxide) Drug: Velcade (Bortezomib) Drug: Melphalan Drug: Vitamin C (Ascorbic Acid)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period June 2006 to December 2008. All participants recruited at UT MD 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
No Bortezomib	Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.0 mg/m^2	Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.5 mg/m^2	Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Participant Flow: Overall Study

	No Bortezomib	Bortezomib 1.0 mg/m^2	Bortezomib 1.5 mg/m^2
STARTED	20	20	20
COMPLETED	19	20	19
NOT COMPLETED	1	0	1
Adverse Event	1	0	1

Baseline Characteristics

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Reporting Groups

	Description
No Bortezomib	Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.0 mg/m^2	Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.5 mg/m^2	Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Baseline Measures

	No Bortezomib	Bortezomib 1.0 mg/m^2	Bortezomib 1.5 mg/m^2	Total
Number of Participants [units: participants]	20	20	20	60
Age [units: years] Median ( Full Range )	61 ( 47 to 70 )	59 ( 45 to 67 )	64 ( 49 to 75 )	60 ( 45 to 75 )
Gender [units: participants]
Female	12	9	6	27
Male	8	11	14	33
Region of Enrollment [units: participants]
United States	20	20	20	60

Outcome Measures

1. Primary:

Number of Patients Reaching Complete Response (CR) [ Time Frame: Baseline through Day 180, with assessments at Day 90 and Day 180 ]

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2. Secondary:

Time to Toxicity [ Time Frame: Baseline to event occurence (assessed weekly first 30 days) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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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
Organization: University of Texas M.D. Anderson Cancer Center
phone: 713-745-3458
e-mail: CR_Study_Registration@mdanderson.org

No publications provided

Responsible Party:	Muzaffar H. Qazilbash, MD/Associate Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00469209 History of Changes
Other Study ID Numbers:	2005-0893
Study First Received:	May 3, 2007
Results First Received:	March 23, 2010
Last Updated:	June 13, 2011
Health Authority:	United States: Institutional Review Board