Insufficient cell mobilization for tandem transplants

This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor 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*10^6 CD34+ cells/kg and the target is ≧4*10^6 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.

This study will examine whether 240 µg/kg plerixafor 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 plerixafor 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*10^6 CD34+ cells/kg and the target is ≧4*10^6 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.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Inclusion Criteria:

• Diagnosis of multiple myeloma (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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Recovered from all acute toxic effects of prior chemotherapy
• White blood cells (WBC) >3.0*10^9/l
• Absolute polymorphonuclear leucocyte (PMN) count >1.5*10^9/l
• Platelet (PLT) count > 150*10^9/l
• Serum creatinine ≦2.2 mg/dl
• Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (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 (a combination of Vincristine, BCNU (Bis-Chloronitrosourea), Melphalan, Cyclophosphamide, and Prednisone)
• 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 plerixafor
• 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

The first day of plerixafor administration up to the day prior to chemotherapy/ablative treatment.

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.

Study had limited enrollment prior to termination.