Cellular Therapy With Cord Blood Cells

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT00427557

First received: January 25, 2007

Last updated: May 23, 2012

Last verified: May 2012

Results First Received: April 19, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Multiple Myeloma Leukemia Lymphoma
Interventions:	Drug: Fludarabine Drug: Melphalan Procedure: Umbilical Cord Blood Drug: Rituximab Other: Peripheral Blood Stem Cell Infusion

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: January 05, 2007 to November 05, 2010. All recruitment done 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
One participant of the 31 was enrolled but did not receive treatment.

Reporting Groups

	Description
Cellular Therapy With Cord Blood Cells	Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion

Participant Flow: Overall Study

	Cellular Therapy With Cord Blood Cells
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Reporting Groups

	Description
Cellular Therapy With Cord Blood Cells	Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion

Baseline Measures

	Cellular Therapy With Cord Blood Cells
Number of Participants [units: participants]	30
Age [units: years] Mean ± Standard Deviation	44 ± 17
Gender [units: participants]
Female	11
Male	19
Region of Enrollment [units: participants]
United States	30

Outcome Measures

1. Primary:

Number of Participants With Engraftment [ Time Frame: Baseline to 100 days post-engraftment ]

Show Outcome Measure 1

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
No text entered.

Results Point of Contact:

Name/Title: Dr. Partow Kebriaei
Organization: MD Anderson Cancer Center
phone: 713-563-5174
e-mail: celsaenz@mdanderson.org

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00427557 History of Changes
Other Study ID Numbers:	2006-0553
Study First Received:	January 25, 2007
Results First Received:	April 19, 2012
Last Updated:	May 23, 2012
Health Authority:	United States: Institutional Review Board