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Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients

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: NCT00322842
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : November 25, 2010
Last Update Posted : March 13, 2014
Sponsor:
Collaborator:
AnorMED
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 Lymphoma, Non-Hodgkin
Multiple Myeloma
Intervention Drug: G-CSF Plus Plerixafor
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Hide Arm/Group Description Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Period Title: Overall Study
Started 4 31
Completed 2 [1] 29 [2]
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             0             1
Refused transplant             1             0
Death             1             0
[1]
One participant discontinued (d/c) treatment early, received a transplant, and completed the study.
[2]
One participant d/c treatment early, received a transplant, and was lost to follow-up after 6 months
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) Total
Hide Arm/Group Description Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Total of all reporting groups
Overall Number of Baseline Participants 4 31 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 31 participants 35 participants
59.8  (8.1) 58.8  (7.3) 58.9  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 31 participants 35 participants
Female
3
  75.0%
12
  38.7%
15
  42.9%
Male
1
  25.0%
19
  61.3%
20
  57.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 31 participants 35 participants
Caucasian 4 30 34
Other 0 1 1
1.Primary Outcome
Title Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)
Hide Description Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 step scale from 'not related' to 'definitely related').
Time Frame Day 1 to approximately Day 38 (before start of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all participants who received at least 1 dose of plerixafor.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
[Not Specified]
Overall Number of Participants Analyzed 4 31 35
Measure Type: Number
Unit of Measure: participants
Participants reporting ≥ 1 AE 4 20 24
AE Severity (Mild) 2 16 18
AE Severity (Moderate) 2 4 6
AE Severity (Severe) 0 0 0
AE Relationship to Drug (Not Related) 4 18 22
AE Relationship to Drug (Probably Not Related) 0 0 0
AE Relationship to Drug (Possibly Related) 0 2 2
AE Relationship to Drug (Probably Related) 0 0 0
AE Relationship to Drug (Definitely Related) 0 0 0
2.Secondary Outcome
Title Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL After First Dose of Plerixafor
Hide Description The fold increase was measured using local lab values and is the ratio of post first dose (pre-apheresis) PB CD34+ cells/µL)/pre-plerixafor dosing PB CD34+ cells/µL)
Time Frame Days 4-5 (first dose of plerixafor to apheresis)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
[Not Specified]
Overall Number of Participants Analyzed 4 31 35
Median (Full Range)
Unit of Measure: ratio
2.6
(2.0 to 4.7)
2.6
(1.1 to 6.9)
2.6
(1.1 to 6.9)
3.Secondary Outcome
Title Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Hide Description Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had transplants. Fifteen participants had tandem transplants. The date of initial PMN engraftment was missing for 11 transplants, which were later shown to have durable grafts.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
[Not Specified]
Overall Number of Participants Analyzed 3 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants
3 45 48
Measure Type: Number
Unit of Measure: number of transplants
≤ Day 12 0 8 8
Day 13 to Day 21 2 25 27
≥ Day 22 1 1 2
Unknown 0 11 11
4.Secondary Outcome
Title Increase in Peripheral Blood (PB) CD34+ Cells From Steady-state Hematopoiesis to Pre-leukapheresis in G-CSF+Plerixafor Treated Participants Compared to Historical Controls Treated With G-CSF Alone or Chemotherapy and G-CSF
Hide Description A comparison of the effectiveness in mobilizing peripheral blood CD34+ cells between this study's treatment regimen (G-CSF plus plerixafor) to other treatment options: G-CSF alone, and chemotherapy with G-CSF.
Time Frame up to day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed. Historical data was not available.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
[Not Specified]
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Median Cumulative Number of CD34+ Cells Collected During Apheresis
Hide Description Median total number of CD34+ cells collected during apheresis as measured by a central lab.
Time Frame Days 5-8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Samples from two participants were not analyzed by the central lab.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
[Not Specified]
Overall Number of Participants Analyzed 4 29 35
Median (Full Range)
Unit of Measure: CD34+ cells (*10^6 / kg)
8.3
(4.9 to 17.6)
7.1
(0.1 to 35.7)
7.4
(0.1 to 35.7)
6.Other Pre-specified Outcome
Title Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Hide Description Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had transplants. Fifteen participants had tandem transplants.
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
[Not Specified]
Overall Number of Participants Analyzed 3 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Transplants
3 45 48
Measure Type: Number
Unit of Measure: number of transplants
≤ Day 12 0 32 32
Day 13 to Day 21 2 13 15
≥ Day 22 1 0 1
7.Other Pre-specified Outcome
Title Number of Participants With Durable Engraftment 12 Months After Transplantation
Hide Description The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.
Time Frame Approximately 13 months (12 months post-transplant )
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had transplants and engraftment data 12 months after transplantation
Arm/Group Title Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM) All Participants
Hide Arm/Group Description:
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
[Not Specified]
Overall Number of Participants Analyzed 2 29 31
Measure Type: Number
Unit of Measure: participants
2 29 31
Time Frame First day of G-CSF administration to the day prior to chemotherapy/ablative treatment in preparation of first transplant. This period includes the G-CSF, plerixafor treatment and rest period.
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 Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Hide Arm/Group Description Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
All-Cause Mortality
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   0/31 (0.00%) 
General disorders     
Pyrexia  1  1/4 (25.00%)  0/31 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus non-insulin-dependent  1  1/4 (25.00%)  0/31 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Hodgkin's Lymphoma (NHL) Multiple Myeloma (MM)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   20/31 (64.52%) 
Blood and lymphatic system disorders     
Anaemia  1  0/4 (0.00%)  2/31 (6.45%) 
Leukopenia  1  0/4 (0.00%)  1/31 (3.23%) 
Lymphadenopathy  1  1/4 (25.00%)  0/31 (0.00%) 
Neutropenia  1  0/4 (0.00%)  1/31 (3.23%) 
Thrombocytopenia  1  0/4 (0.00%)  2/31 (6.45%) 
Cardiac disorders     
Bradycardia  1  0/4 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
Abdominal pain  1  0/4 (0.00%)  1/31 (3.23%) 
Diarrhoea  1  1/4 (25.00%)  2/31 (6.45%) 
Nausea  1  1/4 (25.00%)  3/31 (9.68%) 
Vomiting  1  0/4 (0.00%)  3/31 (9.68%) 
General disorders     
Asthenia  1  1/4 (25.00%)  0/31 (0.00%) 
Catheter site pain  1  0/4 (0.00%)  1/31 (3.23%) 
Oedema  1  0/4 (0.00%)  1/31 (3.23%) 
Pyrexia  1  1/4 (25.00%)  3/31 (9.68%) 
Infections and infestations     
Bacterial infection  1  0/4 (0.00%)  1/31 (3.23%) 
Respiratory tract infection  1  0/4 (0.00%)  1/31 (3.23%) 
Staphylococcal infection  1  0/4 (0.00%)  1/31 (3.23%) 
Injury, poisoning and procedural complications     
Fall  1  0/4 (0.00%)  1/31 (3.23%) 
Mouth injury  1  0/4 (0.00%)  1/31 (3.23%) 
Post procedural diarrhoea  1  1/4 (25.00%)  0/31 (0.00%) 
Procedural pain  1  0/4 (0.00%)  1/31 (3.23%) 
Investigations     
Blood potassium decreased  1  0/4 (0.00%)  1/31 (3.23%) 
C-reactive protein increased  1  0/4 (0.00%)  1/31 (3.23%) 
Weight increased  1  0/4 (0.00%)  1/31 (3.23%) 
Metabolism and nutrition disorders     
Hypocalcaemia  1  0/4 (0.00%)  1/31 (3.23%) 
Hypokalaemia  1  0/4 (0.00%)  5/31 (16.13%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/4 (0.00%)  1/31 (3.23%) 
Back pain  1  0/4 (0.00%)  1/31 (3.23%) 
Bone pain  1  0/4 (0.00%)  1/31 (3.23%) 
Musculoskeletal chest pain  1  0/4 (0.00%)  1/31 (3.23%) 
Pain in extremity  1  0/4 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
Headache  1  0/4 (0.00%)  2/31 (6.45%) 
Hypertonia  1 [1]  0/4 (0.00%)  1/31 (3.23%) 
Hypoaesthesia  1  0/4 (0.00%)  1/31 (3.23%) 
Hypotonia  1 [2]  0/4 (0.00%)  1/31 (3.23%) 
Neuralgia  1  0/4 (0.00%)  1/31 (3.23%) 
Paraesthesia  1  1/4 (25.00%)  1/31 (3.23%) 
Psychiatric disorders     
Anxiety  1  0/4 (0.00%)  1/31 (3.23%) 
Sleep disorder  1  0/4 (0.00%)  2/31 (6.45%) 
Renal and urinary disorders     
Renal pain  1  0/4 (0.00%)  1/31 (3.23%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  0/4 (0.00%)  1/31 (3.23%) 
Vascular disorders     
Cardiovascular insufficiency  1  0/4 (0.00%)  1/31 (3.23%) 
Hypotension  1  0/4 (0.00%)  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
Medical review concluded that this event, which was not related to study drug, would have been more appropriately coded to hypertension.
[2]
Medical review concluded that this event, which was not related to study drug, would have been more appropriately coded to hypotension.
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
Layout table for Results Point of Contact information
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
EMail: medinfo@genzyme.com
Layout table for additonal information
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00322842    
Other Study ID Numbers: AMD3100-EU21
First Submitted: May 4, 2006
First Posted: May 8, 2006
Results First Submitted: October 30, 2010
Results First Posted: November 25, 2010
Last Update Posted: March 13, 2014