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

Multiple Myeloma Clinical Trial

Official title:

Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00396383
• Other study ID #: AMD3100-2108
• Status: Terminated
• Phase: Phase 2
• First received: November 2, 2006
• Last updated: February 10, 2014
• Start date: November 2004
• Est. completion date: May 2007

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• plerixafor
Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4*10^6 CD34+ cells/kg body weight had been collected.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company	AnorMED

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 up to day 4	No
Primary	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).	1 month	Yes
Secondary	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.	Approximately 2 months	No
Secondary	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.	Approximately 2 months	No
Secondary	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.	Approximately month 13	No