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Activated White Blood Cells With ASCT for Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00566098
Recruitment Status : Completed
First Posted : December 3, 2007
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Biological: MILs
Drug: Melphalan
Biological: PCV13
Enrollment 26
Recruitment Details  
Pre-assignment Details There was one screen failure.
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Period Title: Collection of MILs
Started 25
Completed 23
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Relapsed             1
Period Title: Generation of MILs Product
Started 23
Completed 22
Not Completed 1
Reason Not Completed
Relapsed             1
Period Title: Administration of ASCT+MILs
Started 22
Completed 4
Not Completed 18
Reason Not Completed
Death             10
Lack of Efficacy             8
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
56
(30 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
8
  36.4%
Male
14
  63.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  13.6%
White
18
  81.8%
More than one race
0
   0.0%
Unknown or Not Reported
1
   4.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
 100.0%
1.Primary Outcome
Title Hematopoietic Engraftment
Hide Description Days to absolute neutrophil count > 500 cells per microliter.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description:

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: days
17.9
(12 to 32)
2.Primary Outcome
Title Disease Response
Hide Description Percentage of participants with partial or complete response by Bladé criteria. Partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description:

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
7
  31.8%
Partial Response
6
  27.3%
Stable Disease
6
  27.3%
Progressive Disease
3
  13.6%
3.Primary Outcome
Title Feasibility of MILs Generation as Assessed by Percentage of Participants With Successful MIL Generation
Hide Description Success rate of expanding MILs in vitro and obtaining a protocol-specified product.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description:

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
100
4.Secondary Outcome
Title T-cell Reconstitution as Determined by Absolute Lymphocyte Count (ALC)
Hide Description ALC counts trending over time.
Time Frame Days 14, 28, 60, 180, and 360
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on one participant at the Day 28 and 180 timepoints, and data was not collected for eight participants at the Day 360 timepoint. Data was not collected on CD3+/CD4+/CD8+ cells for all participants.
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description:

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: cells per microliter
Day 14 Number Analyzed 22 participants
756
(105 to 2397)
Day 28 Number Analyzed 21 participants
1768
(349 to 3760)
Day 60 Number Analyzed 22 participants
1700
(530 to 3500)
Day 180 Number Analyzed 21 participants
1430
(650 to 2340)
Day 360 Number Analyzed 14 participants
1660
(690 to 2420)
5.Secondary Outcome
Title Survival
Hide Description Survival in months for participants who are alive (Overall Survival) and alive without disease progression (Progression-free survival). Disease progression is defined as a change from negative to positive on immunofixation or electrophoresis for participants previously in complete remission or a 25% increase in serum electrophoresis for participants not previously in complete remission. Partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.
Time Frame Up to 129 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description:
therapeutic autologous lymphocytes
Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: months
Overall survival
112.1
(39.9 to 128.7)
Progression-free survival
12.3
(8.8 to 69.03)
6.Secondary Outcome
Title Pneumococcal-specific Vaccine Responses
Hide Description CRM-197 Prevnar-specific vaccine responses that measure the T-cell response of the vaccine quantified as %CD3+/CFSE-low/IFN-gamma+.
Time Frame At time of bone marrow harvest, Day 60 post-transplant, Day 180 post-transplant, and Day 360 post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description:

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 22
Mean (Full Range)
Unit of Measure: %CD3+/CFSE-low/IFN-gamma+
At time of bone marrow harvest
21.5
(0.12 to 47.9)
Day 60 post-transplant
14.4
(0 to 38.2)
Day 180 post-transplant
23.4
(7 to 53)
Day 360 post-transplant
20.1
(0 to 49.7)
7.Secondary Outcome
Title Anti-tumor Immune Responses
Hide Description Myeloma lysate response that measures the T-cell response quantified as %CD3+/CFSE-low/IFN-gamma+.
Time Frame At time of bone marrow harvest, Day 60 post-transplant, Day 180 post-transplant, and Day 360 post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MILs in Patients Undergoing an Autologous Peripheral SCT
Hide Arm/Group Description:

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

melphalan

autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 22
Mean (Full Range)
Unit of Measure: %CD3+/CFSE-low/IFN-gamma+
At time of bone marrow harvest
1.58
(0 to 12.6)
Day 60 post-transplant
14.1
(0 to 44.3)
Day 180 post-transplant
18.1
(0.6 to 50.1)
Day 360 post-transplant
12.7
(0 to 31.8)
Time Frame Up to Day 360
Adverse Event Reporting Description Per protocol, only adverse events (AEs) that were attributed to the study product (MILs) were collected and reported. AEs were collected daily through the date of engraftment, weekly through Day 28, and then at Days 60, 180, and 360.
 
Arm/Group Title ASCT+MILs
Hide Arm/Group Description Autologous stem cell transplant with a conditioning regimen of melphalan 100 mg/m^2 on each of Days -2 and -1. Infusion of activated marrow infiltrating lymphocytes (MILs) on Day 3. PCV13 vaccine will be given before and/or after Day 0 depending on when participants are enrolled.
All-Cause Mortality
ASCT+MILs
Affected / at Risk (%)
Total   10/22 (45.45%)    
Show Serious Adverse Events Hide Serious Adverse Events
ASCT+MILs
Affected / at Risk (%) # Events
Total   1/22 (4.55%)    
Nervous system disorders   
Syncope  1  1/22 (4.55%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ASCT+MILs
Affected / at Risk (%) # Events
Total   21/22 (95.45%)    
Cardiac disorders   
Hypotension  1  6/22 (27.27%)  6
Tachycardia  1  3/22 (13.64%)  3
Gastrointestinal disorders   
Constipation  1  5/22 (22.73%)  5
Anorexia  1  9/22 (40.91%)  9
Diarrhea  1  12/22 (54.55%)  13
Mucositis  1  9/22 (40.91%)  11
Nausea  1  16/22 (72.73%)  18
Vomiting  1  11/22 (50.00%)  11
General disorders   
Fatigue  1  17/22 (77.27%)  19
Infections and infestations   
Neutropenic fever  1  5/22 (22.73%)  5
Upper respiratory infection  1  2/22 (9.09%)  3
Investigations   
Fever  1  4/22 (18.18%)  4
Musculoskeletal and connective tissue disorders   
Pain - abdomen  1  5/22 (22.73%)  5
Bone pain  1  3/22 (13.64%)  3
Back pain  1  3/22 (13.64%)  3
Pain - calf  1  2/22 (9.09%)  2
Nervous system disorders   
Blurred vision  1  2/22 (9.09%)  2
Depression  1  2/22 (9.09%)  2
Headache  1  7/22 (31.82%)  8
Insomnia  1  2/22 (9.09%)  2
Lightheadedness  1  2/22 (9.09%)  2
Neuropathy  1  15/22 (68.18%)  21
Renal and urinary disorders   
Urinary frequency  1  4/22 (18.18%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/22 (18.18%)  4
Dyspnea  1  5/22 (22.73%)  5
Skin and subcutaneous tissue disorders   
Alopecia  1  3/22 (13.64%)  3
Itching  1  2/22 (9.09%)  3
Rash  1  12/22 (54.55%)  22
Sore throat  1  7/22 (31.82%)  7
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ivan Borrello, MD
Organization: Johns Hopkins University
Phone: 4109554967
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00566098     History of Changes
Other Study ID Numbers: J0770
P30CA006973 ( U.S. NIH Grant/Contract )
NA_00012038 ( Other Identifier: JHMIRB )
First Submitted: November 30, 2007
First Posted: December 3, 2007
Results First Submitted: September 14, 2018
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018