Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    amd3100-2109
Previous Study | Return to List | Next Study

AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00395967
Recruitment Status : Terminated (Enrollment terminated in 2005 to focus on Phase 3 study enrollment.)
First Posted : November 6, 2006
Results First Posted : August 13, 2010
Last Update Posted : May 1, 2015
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Lymphoma, Non-Hodgkin's
Intervention Drug: G-CSF plus plerixafor
Enrollment 5
Recruitment Details Study enrollment began in April 2005 and the study was terminated in August 2006. Target enrollment was 15 patients, however the trial was terminated early after five patients were enrolled.
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Period Title: Treatment Period
Started 5
Completed 4 [1]
Not Completed 1
Reason Not Completed
Failed Mobilization             1
[1]
Failed mobilization due to <2 fold yield after one day of plerixafor treatment
Period Title: Follow-up Period
Started 5 [1]
Completed 3
Not Completed 2
Reason Not Completed
Death             1
Lost to Follow-up             1
[1]
Participants who had transplants.
Arm/Group Title All Patients
Hide Arm/Group Description Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
52.2  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 5 participants
5
Disease Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants
Multiple Myeloma (MM) 1
Non-Hodgkin's lymphoma (NHL) 3
Hodgkin's disease (HD) 1
[1]
Measure Description: One patient with HD was entered into the study even though there was no indication of MM or NHL (an inclusion criteria).
1.Primary Outcome
Title Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days
Hide Description The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.
Time Frame approximately days 6-9
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received plerixafor.
Arm/Group Title All Patients
Hide Arm/Group Description:
Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Participants with ≥2*10^6 CD34+ cells/kg 3
Participants with <2*10^6 CD34+ cells/kg 2
2.Secondary Outcome
Title Overall Participants Counts of Adverse Events
Hide Description Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
Time Frame up to 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population defined as all participants who received G-CSF and/or plerixafor.
Arm/Group Title All Patients
Hide Arm/Group Description:
Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Participants Reporting At Least One AE 5
Participants Reporting a Severe AE 4
Participants Reporting a Life-threatening AE 2
AE Relation to Drug: Not Related or Probably Not 3
AE Relation to Drug: Possibly Related 2
AE Relation to Drug: Probably or Definitely Relate 0
Serious Adverse Events 4
AEs Leading to Discontinuation 0
3.Secondary Outcome
Title The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor
Hide Description

The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).

This study was terminated early and analysis was not done.

Time Frame Days 5-6
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and analysis was not done.
Arm/Group Title All Patients
Hide Arm/Group Description:
Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
Hide Description

The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.

This study was terminated early and analysis was not done.

Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and analysis was not done.
Arm/Group Title All Patients
Hide Arm/Group Description:
Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Days to Platelet (PLT) Engraftment
Hide Description

The median number of days to platelet (PLT) engraftment criteria was ≥ 20*10^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.

This study was terminated early and analysis was not done.

Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and analysis was not done.
Arm/Group Title All Patients
Hide Arm/Group Description:
Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Graft Durability at 12 Months After Transplantation
Hide Description

Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.

This study was terminated early and analysis was not done.

Time Frame 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and analysis was not done.
Arm/Group Title All Patients
Hide Arm/Group Description:
Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame All treatment-emergent AEs are summarized. An event whose onset was on or after the first administration of study treatment (either G-CSF or plerixafor) was considered treatment-emergent.
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events regardless of reported relationship to study treatment or grade.
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients (3 NHL, 1 MM, and 1 HD).
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   4/5 (80.00%) 
Cardiac disorders   
Acute myocardial infarction  1 [1]  1/5 (20.00%) 
Gastrointestinal disorders   
Vomiting  1  1/5 (20.00%) 
General disorders   
Disease progression  1  1/5 (20.00%) 
Renal and urinary disorders   
Renal failure acute  1  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
Acute MI: Onset 15 days after last plerixafor dose, occurred during stem cell infusion, and assessed unrelated.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%)
Total   5/5 (100.00%) 
Gastrointestinal disorders   
Abdominal pain  1  1/5 (20.00%) 
Constipation  1  1/5 (20.00%) 
Nausea  1  3/5 (60.00%) 
General disorders   
Chills  1  1/5 (20.00%) 
Fatigue  1  1/5 (20.00%) 
Pyrexia  1  1/5 (20.00%) 
Infections and infestations   
Infection  1  1/5 (20.00%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/5 (20.00%) 
Musculoskeletal pain  1  1/5 (20.00%) 
Pain in extremity  1  1/5 (20.00%) 
Nervous system disorders   
Headache  1  2/5 (40.00%) 
Paraesthesia  1  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/5 (60.00%) 
Paranasal sinus hypersecretion  1  1/5 (20.00%) 
Skin and subcutaneous tissue disorders   
Skin reaction  1  1/5 (20.00%) 
Skin tightness  1  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Limited enrollment due to early termination of the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00395967     History of Changes
Other Study ID Numbers: AMD3100-2109
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: January 27, 2009
Results First Posted: August 13, 2010
Last Update Posted: May 1, 2015