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

This study has been terminated.
(Insufficient cell mobilization for tandem transplants)
Sponsor:
Collaborator:
AnorMED
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00396383
First received: November 2, 2006
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: plerixafor
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg [ Time Frame: Day 1 up to day 4 ] [ Designated as safety issue: No ]
    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.

  • Participant Counts of Summarized Adverse Events (AE) During Treatment [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
    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.

  • Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Durable Graft at 12 Months Post Transplantation [ Time Frame: Approximately month 13 ] [ Designated as safety issue: No ]
    Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.


Enrollment: 9
Study Start Date: November 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants with Multiple Myeloma (MM)
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.
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.
Other Names:
  • Mozobil
  • AMD3100

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396383

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Genzyme, a Sanofi Company
AnorMED
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Publications:
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.

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00396383     History of Changes
Other Study ID Numbers: AMD3100-2108
Study First Received: November 2, 2006
Results First Received: February 11, 2009
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Multiple Myeloma
Stem cell mobilization
apheresis

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
JM 3100
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014