Trial Outcomes & Findings for Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma (NCT NCT01245673)
NCT ID: NCT01245673
Last Updated: 2020-04-06
Results Overview
To determine whether lenalidomide maintenance plus the late booster immunizations leads to improved myeloma clinical responses between day 180 and day 100 post-transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Between day 100 and 180 post transplant
Results posted on
2020-04-06
Participant Flow
Participant milestones
| Measure |
MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide,
MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.
Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.
Day 2 Activated/costimulated autologous T cells.
Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.
Day 100 start Lenalidomide.
Day 120 and 150 MAGE-A3 and PVC.
|
|---|---|
|
Enrollment
STARTED
|
28
|
|
Enrollment
COMPLETED
|
27
|
|
Enrollment
NOT COMPLETED
|
1
|
|
Pre Transplant Vaccinations
STARTED
|
27
|
|
Pre Transplant Vaccinations
Pre Transplant Vaccinations 1-3
|
27
|
|
Pre Transplant Vaccinations
COMPLETED
|
27
|
|
Pre Transplant Vaccinations
NOT COMPLETED
|
0
|
|
Activated/Costimulated Autologous T Cell
STARTED
|
27
|
|
Activated/Costimulated Autologous T Cell
COMPLETED
|
27
|
|
Activated/Costimulated Autologous T Cell
NOT COMPLETED
|
0
|
|
MAGE-A3, Hiltonol®, PVC After T Cells
STARTED
|
27
|
|
MAGE-A3, Hiltonol®, PVC After T Cells
COMPLETED
|
26
|
|
MAGE-A3, Hiltonol®, PVC After T Cells
NOT COMPLETED
|
1
|
|
Start Lenalidomide
STARTED
|
26
|
|
Start Lenalidomide
COMPLETED
|
26
|
|
Start Lenalidomide
NOT COMPLETED
|
0
|
|
Maintenance: MAGE-A3, PVC After T Cells
STARTED
|
26
|
|
Maintenance: MAGE-A3, PVC After T Cells
COMPLETED
|
26
|
|
Maintenance: MAGE-A3, PVC After T Cells
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide,
MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.
Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.
Day 2 Activated/costimulated autologous T cells.
Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.
Day 100 start Lenalidomide.
Day 120 and 150 MAGE-A3 and PVC.
|
|---|---|
|
MAGE-A3, Hiltonol®, PVC After T Cells
Off Study due to Disease Progression
|
1
|
Baseline Characteristics
Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma
Baseline characteristics by cohort
| Measure |
Prevnar, T Cells, Lenalidomide, MAGE A-3
n=27 Participants
MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.
Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.
Day 2 Activated/costimulated autologous T cells.
Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.
Day 100 start Lenalidomide.
Day 120 and 150 MAGE-A3 and PVC.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
52.48 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Between day 100 and 180 post transplantPopulation: Subjects that reached D100 and D180
To determine whether lenalidomide maintenance plus the late booster immunizations leads to improved myeloma clinical responses between day 180 and day 100 post-transplant.
Outcome measures
| Measure |
Prevnar, T Cells, Lenalidomide, MAGE A-3
n=26 Participants
All patients will receive a priming immunization with a MAGE-A3/GM-CSF vaccine with adjuvant Hiltonol® (Poly-ICLC) along with the pneumococcal conjugate vaccine/PCV control vaccine about 10 days before a steady-state mononuclear cell apheresis. Patients will then undergo hematopoietic stem cell mobilization. All patients will receive high-dose melphalan followed by hematopoietic stem cells on day 0.
|
|---|---|
|
Primary Myeloma Endpoint
Subjects in CR D100 and D180
|
4 Participants
|
|
Primary Myeloma Endpoint
Subjects in sCR D100 and 180
|
1 Participants
|
|
Primary Myeloma Endpoint
Subjects in VGPR D100 and D180
|
1 Participants
|
|
Primary Myeloma Endpoint
Subjects in PR D100 and D180
|
5 Participants
|
|
Primary Myeloma Endpoint
Subjects with SD at D+100 and 180
|
3 Participants
|
|
Primary Myeloma Endpoint
Subjects with improved response at D100 and D180
|
6 Participants
|
|
Primary Myeloma Endpoint
Subjects with poorer response at D100 and D180
|
4 Participants
|
|
Primary Myeloma Endpoint
Subjects with no disease response reported
|
2 Participants
|
Adverse Events
Prevnar, T Cells, Lenalidomide, MAGE A-3
Serious events: 9 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevnar, T Cells, Lenalidomide, MAGE A-3
n=27 participants at risk
MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.
Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.
Day 2 Activated/costimulated autologous T cells.
Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.
Day 100 start Lenalidomide.
Day 120 and 150 MAGE-A3 and PVC.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Chills
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing/shortness of breath
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Fever
|
7.4%
2/27 • Number of events 2 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Flu like symptoms
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Hypothermia
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Infections and infestations
Influenza B
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Infusion site Extravasation
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Investigations
Neutrophil count decreased
|
11.1%
3/27 • Number of events 3 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Investigations
Platelet count decreased
|
7.4%
2/27 • Number of events 2 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Infections and infestations
Pneumonia
|
14.8%
4/27 • Number of events 5 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Cardiac disorders
Sinus bradycardia
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Skin Indurations w/erythema
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Infections and infestations
Sterile abscess w/drainage
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.7%
1/27 • Number of events 1 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
Other adverse events
| Measure |
Prevnar, T Cells, Lenalidomide, MAGE A-3
n=27 participants at risk
MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis.
Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0.
Day 2 Activated/costimulated autologous T cells.
Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC.
Day 100 start Lenalidomide.
Day 120 and 150 MAGE-A3 and PVC.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
9/27 • Number of events 14 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Chills
|
18.5%
5/27 • Number of events 7 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Gastrointestinal disorders
Diarrhea
|
14.8%
4/27 • Number of events 5 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Fatigue
|
25.9%
7/27 • Number of events 7 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Fever
|
37.0%
10/27 • Number of events 16 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Infections and infestations
Flu-like symptoms
|
7.4%
2/27 • Number of events 3 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.4%
2/27 • Number of events 2 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Nervous system disorders
Headache
|
29.6%
8/27 • Number of events 10 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Blood and lymphatic system disorders
Increased eosinophil
|
7.4%
2/27 • Number of events 3 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Induration
|
11.1%
3/27 • Number of events 5 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Induration - thigh
|
7.4%
2/27 • Number of events 2 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Induration at injection site
|
25.9%
7/27 • Number of events 14 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Induration/Swelling
|
14.8%
4/27 • Number of events 7 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Injection site reaction
|
29.6%
8/27 • Number of events 36 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Nervous system disorders
Loss of energy
|
29.6%
8/27 • Number of events 13 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
40.7%
11/27 • Number of events 17 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Gastrointestinal disorders
Nausea
|
18.5%
5/27 • Number of events 6 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Investigations
Neutrophil count decreased
|
7.4%
2/27 • Number of events 2 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Gastrointestinal disorders
Pain at injection site
|
59.3%
16/27 • Number of events 40 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.4%
2/27 • Number of events 3 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
3/27 • Number of events 3 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Skin and subcutaneous tissue disorders
Rash - lower extremity
|
7.4%
2/27 • Number of events 2 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
General disorders
Swelling at injection site
|
7.4%
2/27 • Number of events 2 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
|
Musculoskeletal and connective tissue disorders
Swelling/Induration
|
25.9%
7/27 • Number of events 9 • Adverse event reporting begins at the time of T-cell harvest and continues until day 180 post infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place