UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide

This study has been terminated.

(low accrual)

Sponsor:

Information provided by:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT00574080

First received: December 12, 2007

Last updated: June 1, 2011

Last verified: June 2011

History of Changes

Results First Received: May 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Multiple Myeloma
Interventions:	Drug: Dexamethasone Drug: DPACE/Melphalan

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
Participants are myeloma patients who have already received one or more treatment regimens and are seen at our facility

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
VTD + DPACE/Melphalan	Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
DPACE/Melphalan	Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan

Participant Flow: Overall Study

	VTD + DPACE/Melphalan	DPACE/Melphalan
STARTED	10	10
COMPLETED	0	0
NOT COMPLETED	10	10
Death	10	10

Baseline Characteristics

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Reporting Groups

	Description
VTD + DPACE/Melphalan	Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
DPACE/Melphalan	Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
Total	Total of all reporting groups

Baseline Measures

	VTD + DPACE/Melphalan	DPACE/Melphalan	Total
Number of Participants [units: participants]	10	10	20
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	10	6	16
>=65 years	0	4	4
Age [units: years] Mean ± Standard Deviation	56.2 ± 5.01	59 ± 8.67	57.6 ± 7.04
Gender [units: participants]
Female	6	5	11
Male	4	5	9
Region of Enrollment [units: participants]
United States	10	10	20

Outcome Measures

1. Primary:

Addition of Bortezomib, Thalidomide, and Dexamethasone to High Dose Chemotherapy Regimen Immediately Before Transplant [ Time Frame: 24 months ]

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2. Secondary:

Side Effects With Both Transplant Regimens [ Time Frame: 24 months ]

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

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
Early termination led to small numbers of subjects to be analyzed. Less than 10% of the target accrual were enrolled before termination of study.

Results Point of Contact:

Name/Title: Nathan M. Petty
Organization: University of Arkansas for Medical Sciences, Myeloma Institute
phone: 501-526-6990 ext 2461
e-mail: PettyNathanM@uams.edu

No publications provided

Responsible Party:	Frits van Rhee, MD, PhD, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier:	NCT00574080 History of Changes
Other Study ID Numbers:	2006-15
Study First Received:	December 12, 2007
Results First Received:	May 4, 2011
Last Updated:	June 1, 2011
Health Authority:	United States: Institutional Review Board

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