Long-Term Follow-up Study for Multiple Myeloma Patients Who Received Autologous Transplantation in the AMD3100-3102 Study - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00741780

Purpose

This is a long-term observational study of transplanted patients that participated in the AMD3100-3102 protocol.

Condition
Multiple Myeloma Autologous Transplantation

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Granulocyte colony-stimulating factor JM 3100

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Long-Term Observational Follow-up Study of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 6X 10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

Further study details as provided by Genzyme:

Primary Outcome Measures:

To assess disease-free survival and overall survival in transplanted patients from the phase III AMD3100-3102 study [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	125
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2010

Detailed Description:

This is a long-term observational study of transplanted patients that have completed a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus GCSF versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD3100-3102-LTF). The objective of this study is to assess disease-free survival and overall survival for a period of three years following the initial 12-month post-transplantation follow-up of the investigational study

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from the AMD3100-3102 who received a stem cell transplant

Criteria

Inclusion Criteria:

All patients who received a stem cell transplant in protocol AMD3100-3102

Exclusion Criteria:

No Exclusion Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741780

Sponsors and Collaborators

Genzyme

Investigators

Study Director:	Frank Hsu, MD	Genzyme
Principal Investigator:	Patrick Stiff, MD	Loyola University

More Information

Responsible Party:	Genzyme Corporation ( Frank Hsu, MD )
Study ID Numbers:	AMD3100-3102-LTF
Study First Received:	August 22, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741780
Health Authority:	United States: Food and Drug Administration; Germany: BfArM

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
JM 3100
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009