Clinical trial NCT00396383: Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation
Official title: Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Stem cell mobilization
apheresis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: AnorMED
First posted: 2006-11-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg
timeFrame: Day 1 up to day 4
measure: Participant Counts of Summarized Adverse Events (AE) During Treatment
timeFrame: 1 month
Secondary outcomes:
measure: Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment
timeFrame: Approximately 2 months
measure: Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment
timeFrame: Approximately 2 months
measure: Number of Participants With a Durable Graft at 12 Months Post Transplantation
timeFrame: Approximately month 13
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Flomenberg N, Comenzo R, Badel K, Calandra G. Single agent AMD3100 mobilization of peripheral blood progenitor cells for autologous transplantation in patients with multiple myeloma (MM) [abstract]. Blood. Nov 16 2006;108(11 Pt 1):965a.
citation: Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.