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

Phase 2TerminatedNCT00396383

Genzyme, a Sanofi Company9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg

Number of participants achieving a target of ≥ 4\*10\^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.

Time frame: Day 1 up to day 4

Participant Counts of Summarized Adverse Events (AE) During Treatment

Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).

Time frame: 1 month

Secondary Outcomes

Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment

Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5\*10\^9/L for 3 consecutive days or ≥ 1\*10\^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.

Time frame: Approximately 2 months

Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment

Platelet (PLT) engraftment was defined as a PLT count of ≥ 20\*10\^9/L for 7 days without transfusion. Days to engraftment corresponded to the first day that the criteria were met after transplantation.

Time frame: Approximately 2 months

Number of Participants With a Durable Graft at 12 Months Post Transplantation

Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.

Time frame: Approximately month 13