Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
18 Years
75 Years
Both
Multiple Myeloma
Trial Information
Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg
Outcome Description:
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.
Outcome Time Frame:
Day 1 up to day 4
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Genzyme
Authority:
United States: Food and Drug Administration
Study ID:
AMD3100-2108
NCT ID:
NCT00396383
Start Date:
November 2004
Completion Date:
May 2007
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Stem cell mobilization
- apheresis
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
