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Trial record 1 of 1 for:    amd3100-2108
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Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation

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ClinicalTrials.gov Identifier: NCT00396383
Recruitment Status : Terminated (Insufficient cell mobilization for tandem transplants)
First Posted : November 6, 2006
Results First Posted : October 21, 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
Condition Multiple Myeloma
Intervention Drug: plerixafor
Enrollment 9
Recruitment Details Study enrollment began in November 2004 and the study was terminated in May 2007. A total of 20 participants were planned for this study, however the study was terminated early because of insufficient mobilization of CD34+ cells after treatment with plerixafor alone for use in tandem transplants.
Pre-assignment Details  
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Period Title: Overall Study
Started 9
Completed 6
Not Completed 3
Reason Not Completed
Death             2
Lost to Follow-up             1
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
62.0  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
6
  66.7%
Male
3
  33.3%
1.Primary Outcome
Title Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received plerixafor
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description:
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Participants Who Achieved ≥4*10^6 cells 4
Participants Who Achieved <4*10^6 cells 5
2.Primary Outcome
Title Participant Counts of Summarized Adverse Events (AE) During Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received plerixafor
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description:
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
AE Severity (Mild) 3
AE Severity (Moderate) 6
AE Severity (Severe) 0
Life-threatening AE 0
AE Relationship to Drug (Not related) 4
AE Relationship to Drug (Probably not related) 1
AE Relationship to Drug (Possibly related) 1
AE Relationship to Drug (Probably related) 3
AE Relationship to Drug (Definitely related) 0
3.Secondary Outcome
Title Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants.
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description:
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Overall Number of Participants Analyzed 9
Overall Number of Units Analyzed
Type of Units Analyzed: Transplantations
10
Measure Type: Number
Unit of Measure: transplantations
<= Day 12 post transplant 10
Day 13 to 21 post transplant 0
>= Day 22 post transplant 0
4.Secondary Outcome
Title Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants. One participant did not have PLT samples collected (included as 'unknown' in data table).
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description:
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Overall Number of Participants Analyzed 9
Overall Number of Units Analyzed
Type of Units Analyzed: Transplantations
10
Measure Type: Number
Unit of Measure: transplantations
<= Day 12 post transplant 0
Day 13 to 21 post transplant 6
>= Day 22 post transplant 3
Unknown 1
5.Secondary Outcome
Title Number of Participants With a Durable Graft at 12 Months Post Transplantation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population includes participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant.
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description:
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
6
6.Post-Hoc Outcome
Title Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg
Hide Description Number of participants achieving ≥ 2*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). Total 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received plerixafor
Arm/Group Title Participants With Multiple Myeloma (MM)
Hide Arm/Group Description:
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
9
Time Frame The first day of plerixafor administration up to the day prior to chemotherapy/ablative treatment.
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 Participants With Multiple Myeloma (MM)
Hide Arm/Group Description Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
All-Cause Mortality
Participants With Multiple Myeloma (MM)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Multiple Myeloma (MM)
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Multiple Myeloma (MM)
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/9 (11.11%) 
Gastrointestinal disorders   
Abdominal distension  1  1/9 (11.11%) 
Diarrhoea  1  1/9 (11.11%) 
Nausea  1  1/9 (11.11%) 
Paraesthesia oral  1  3/9 (33.33%) 
Vomiting  1  1/9 (11.11%) 
General disorders   
Catheter site erythema  1  1/9 (11.11%) 
Catheter site related reaction  1  1/9 (11.11%) 
Infusion site bruising  1  1/9 (11.11%) 
Injection site erythema  1  3/9 (33.33%) 
Oedema peripheral  1  1/9 (11.11%) 
Pain  1  1/9 (11.11%) 
Infections and infestations   
Urinary tract infection  1  1/9 (11.11%) 
Vulvovaginal mycotic infection  1  1/9 (11.11%) 
Injury, poisoning and procedural complications   
Contusion  1  1/9 (11.11%) 
Investigations   
Heart rate irregular  1  1/9 (11.11%) 
Platelet count decreased  1  1/9 (11.11%) 
Syphilis test positive  1 [1]  1/9 (11.11%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/9 (11.11%) 
Nervous system disorders   
Dysgeusia  1  1/9 (11.11%) 
Headache  1  2/9 (22.22%) 
Hypoaesthesia  1  1/9 (11.11%) 
Poor quality sleep  1  1/9 (11.11%) 
Psychiatric disorders   
Insomnia  1  1/9 (11.11%) 
Restlessness  1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Night sweats  1  1/9 (11.11%) 
Rash  1  1/9 (11.11%) 
Swelling face  1  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
Female- history of syphilis- previous treatment unknown. On Day 3 plerixafor therapy, tested positive for (1:16) rapid plasma reagin titer. Doxycycline given for 5 weeks. No post-treatment titer and no comment made at her 12-month follow-up visit.
Study had limited enrollment prior to termination.
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
Publications of Results:
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
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: February 11, 2009
Results First Posted: October 21, 2010
Last Update Posted: March 13, 2014