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

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
plerixafor
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Stem cell mobilization, apheresis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center
  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Multiple Myeloma (MM)

Arm Description

Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 2, 2006
Last Updated
February 10, 2014
Sponsor
Genzyme, a Sanofi Company
Collaborators
AnorMED
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1. Study Identification

Unique Protocol Identification Number
NCT00396383
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient cell mobilization for tandem transplants
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company
Collaborators
AnorMED

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Stem cell mobilization, apheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with Multiple Myeloma (MM)
Arm Type
Experimental
Arm Description
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.
Intervention Type
Drug
Intervention Name(s)
plerixafor
Other Intervention Name(s)
Mozobil, AMD3100
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg
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.
Time Frame
Day 1 up to day 4
Title
Participant Counts of Summarized Adverse Events (AE) During Treatment
Description
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 Outcome Measure Information:
Title
Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment
Description
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
Title
Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment
Description
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
Title
Number of Participants With a Durable Graft at 12 Months Post Transplantation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
PubMed Identifier
20067838
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.
Results Reference
result

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

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