Treatment With AMD3100 in MM Patients to Mobilize PBCs For Collection and for Transplantation - Full Text View

Sponsors and Collaborators:	Genzyme AnorMED
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00396383

Purpose

This study will examine whether 240 µg/kg AMD3100 given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if AMD3100 alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2 x 10e6 CD34+ cells/kg and the target is ≧4 x 10e6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of transplant will be assessed for a minimum of one year.

Condition	Intervention	Phase
Multiple Myeloma	Drug: AMD3100 Procedure: stem cell mobilization Procedure: autologous transplantation Procedure: apheresis	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: JM 3100

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation

Further study details as provided by Genzyme:

Primary Outcome Measures:

To determine if 240 μg/kg AMD3100 given alone, as a sc injection for up to 4 days, is safe and well tolerated in MM patients.
To determine if AMD3100 alone, when given to patients with MM, will result in a total apheresis yield of ≧4 x10^6 CD34+ cells/kg in up to 4 consecutive days.

Secondary Outcome Measures:

To determine the times to PMN and PLT engraftment.
To determine the durability of engraftment.
To assess the mobilization of MM cells.

Enrollment:	9
Study Start Date:	November 2004
Study Completion Date:	May 2007

Detailed Description:

This study will examine whether 240 µg/kg AMD3100 given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if 240 µg/kg AMD3100 alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2 x 10e6 CD34+ cells/kg and the target is ≧4 x 10e6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of engraftment will be assessed for a minimum of one year.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of MM
Eligible for autologous transplantation
Patients in first or second partial remission (PR) or complete remission (CR)
Patients who have received ≦2000 rads of prior radiation therapy
ECOG performance status of 0 or 1
Recovered from all acute toxic effects of prior chemotherapy
WBC >3.0 x 10e9/l
Absolute PMN count >1.5 x 10e9/l
PLT count > 150 x 10e9/l
Serum creatinine ≦2.2 mg/dl
SGOT, SGPT and total bilirubin <2 x upper limit of normal (ULN)
Negative for HIV
Signed informed consent
Patients of childbearing potential agree to use an approved form of contraception

Exclusion Criteria:

Patient received 2 or more alkylating agents, such as VBMCP
Patient received a total dose of ≧200 mg of prior melphalan
A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
Patient has failed previous collections or collection attempts
A residual acute medical condition resulting from prior chemotherapy
Brain metastases or carcinomatous meningitis
Acute infection
Fever (temperature >38 °C / 100.4 °F)
Hypercalcemia (>1mg/dl above ULN)
Positive pregnancy test in female patients
Lactating females
Patients of childbearing potential unwilling to implement adequate birth control
Patients whose actual body weight exceeds 175% of their ideal body weight
History of ventricular arrhythmias
Patient received thalidomide within 10 days prior to receiving the first dose of AMD3100
Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396383

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Genzyme

AnorMED

Investigators

Principal Investigator:

Neal Flomenberg, MD

Thomas Jefferson University

More Information

Study ID Numbers:	AMD3100-2108
Study First Received:	November 2, 2006
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00396383
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Multiple Myeloma
Stem cell mobilization
apheresis

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:

Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Histologic Type
Anti-Retroviral Agents

Immune System Diseases
Therapeutic Uses
Cardiovascular Diseases
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009