Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis

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: NCT00075608
Recruitment Status : Terminated (poor accrual)
First Posted : January 12, 2004
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Karen Quillen, Boston Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Plasma Cell Neoplasm
Interventions Biological: filgrastim
Drug: melphalan
Procedure: autologous stem cell transplantation
Procedure: stem cell infusion
Enrollment 12
Recruitment Details Participants were recruited from March 2003 through July 2008 through the transplant clinic and amyloid clinic.
Pre-assignment Details  
Arm/Group Title Second Transplant
Hide Arm/Group Description Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Second Transplant
Hide Arm/Group Description Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
54.25  (1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Feasibility and Tolerability
Hide Description Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
Time Frame 3 months after treatment and annually
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed due to study termination
Arm/Group Title Second Transplant
Hide Arm/Group Description:
Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Response and Durability of Response
Hide Description Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
Time Frame 3 months after treatment and annually
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed due to study termination
Arm/Group Title 2nd SCT
Hide Arm/Group Description:

Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning

filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC

melphalan: 140-200 mcg/kg IV over two days

autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0

peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Evaluate Immune Reconstitution
Hide Description Evaluate immune reconstitution based on time to engraftment
Time Frame 3 months after treatment and annually
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed due to study termination
Arm/Group Title 2nd SCT
Hide Arm/Group Description:

Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning

filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC

melphalan: 140-200 mcg/kg IV over two days

autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0

peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description Adverse events were assessed for up to 1 year.
 
Arm/Group Title Second Transplant
Hide Arm/Group Description Participants who received a second transplant
All-Cause Mortality
Second Transplant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Second Transplant
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Blood and lymphatic system disorders   
Sepsis  1 [1]  2/12 (16.67%)  3
Cardiac disorders   
hypotension  1 [2]  5/12 (41.67%)  5
arrhythmia  1  2/12 (16.67%)  2
Gastrointestinal disorders   
nausea  1 [2]  3/12 (25.00%)  3
diarrhea  1 [2]  5/12 (41.67%)  5
General disorders   
fatigue  1 [3]  8/12 (66.67%)  8
Infections and infestations   
febrile neutropenia  1 [3]  8/12 (66.67%)  8
Renal and urinary disorders   
Acute renal failure  1 [1]  2/12 (16.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade IV
[2]
Grade III
[3]
Grade III and IV
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Second Transplant
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Blood and lymphatic system disorders   
peripheral edema  1  2/12 (16.67%)  2
Gastrointestinal disorders   
nausea  1  9/12 (75.00%)  13
diarrhea  1  5/12 (41.67%)  6
Investigations   
hypocalcemia  1  2/12 (16.67%)  2
hypoalbuminemia  1  3/12 (25.00%)  3
Respiratory, thoracic and mediastinal disorders   
dyspnea  1  3/12 (25.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: Boston Medical Center
Phone: 617-638-8261
EMail: sfenness@bu.edu
Layout table for additonal information
Responsible Party: Karen Quillen, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00075608     History of Changes
Other Study ID Numbers: CDR0000347379
H-22603 ( Other Identifier: Boston University Medical Center IRB )
First Submitted: January 9, 2004
First Posted: January 12, 2004
Results First Submitted: August 20, 2014
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017