AMD31002108: Treatment With AMD3100 in MM Patients to Mobilize PBCs For Collection and for Transplantation

This study has been completed.

Sponsored By:	Genzyme AnorMED Corporation, a wholly owned subsidiary of Genzyme
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

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:

Primary Outcomes: 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 x10e6 CD34+ cells/kg in up to 4 consecutive days.
Secondary Outcomes: To determine the times to PMN and PLT engraftment.; To determine the durability of engraftment.; To assess the mobilization of MM cells.

Expected Total Enrollment: 9

Study Start: 2004-11; Study Completion: 2007-05

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 - 75 Years

Genders Eligible for Study: Both

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

Location and Contact Information

United States, New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States

United States, Pennsylvania
Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States

More Information
Study ID Numbers: AMD3100-2108
ClinicalTrials.gov Identifier: NCT00396383
Health Authority: United States: Food and Drug Administration