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Study Summary
No. 2006-0665:.......Myeloma......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:		2006-0665
Study Title:LONG-TERM OBSERVATIONAL FOLLOW-UP STUDY OF A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, COMPARATIVE TRIAL OF AMD3100 (240 MCG/KG) PLUS G-CSF (10 MCG/KG) VERSUS G-CSF (10 MCG/KG) PLUS PLACEBO TO MOBILIZE AND COLLECT >/= 6 x 10^6 CD34+ CELLS/KG IN MULTIPLE MYELOMA PATIENTS FOR AUTOLOGOUS TRANSPLANTATION
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Physician New Patient Referral
Name:Chitra M. HosingPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:MyelomaSupported By:N/A
Phase of Study:N/AReturn
Visit:		Follow up by telephone calls only. Patient does not have to come to MDACC
Treatment
Agents:		AMD3100Home Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		None
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
The objective of this long-term observational study is to assess progression-free survival and overall survival for a period of five years following the first dose of study treatment (placebo or plerixafor [AMD3100]) in protocol AMD3100-3102. Patients that received at least 1 dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind, placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are eligible.
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Study Status Information
Study Activation / Registration Date:10/30/2006
IRB Review and Approval Date:09/20/2006
Study Type:Phase Iii
Recruitment Status:Closed
Projected Accrual:300
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) All patients who received the study drug (placebo or plerixafor) on protocol AMD3100-3102 (2004-0982)
Exclusion Criteria:1) None
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Links
Registration Number: NCT00476294
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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