Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation

Genzyme

Status and phase

Terminated

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: plerixafor

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396383

AMD3100-2108

Details and patient eligibility

About

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.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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