Trial Outcomes & Findings for Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma (NCT NCT01858558)
NCT ID: NCT01858558
Last Updated: 2020-06-29
Results Overview
Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
120 days
Results posted on
2020-06-29
Participant Flow
Participants were enrolled at four sites: Johns Hopkins University, Moffitt Cancer Center, Mayo Clinic (Jacksonville) and the Blood and Marrow Transplant Group of Georgia (Northside).
Of the 102 patients randomized, one was randomized to the control group who was lost to follow-up prior to start; did not have aMILs harvested, and was not transplanted. This patient is therefore not included in this report.
Participant milestones
| Measure |
aMIL Arm
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
31
|
|
Overall Study
COMPLETED
|
61
|
29
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
aMIL Arm
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Disease progression
|
3
|
1
|
|
Overall Study
Product contamination
|
2
|
0
|
|
Overall Study
Failed expansion of cell product
|
2
|
0
|
Baseline Characteristics
Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Baseline characteristics by cohort
| Measure |
aMIL Arm
n=70 Participants
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
n=31 Participants
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
59.0 years
n=7 Participants
|
61.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
53 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
31 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Disease Status
Newly Diagnosed
|
60 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Disease Status
Relapsed
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Myeloma Prognostic Risk Signature (MYPRS) Risk Category
High Risk
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Myeloma Prognostic Risk Signature (MYPRS) Risk Category
Low Risk
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Myeloma Prognostic Risk Signature (MYPRS) Risk Category
N/A
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Myeloma Prognostic Risk Signature (MYPRS) Risk Category
Indeterminate
|
25 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
70-gene expression Prognostic Risk Score (GEP-70)
Not High Risk
|
58 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
70-gene expression Prognostic Risk Score (GEP-70)
High Risk
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
27 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 or 2
|
34 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
International Staging System (ISS) Multiple Myeloma Classification
Stage I
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
International Staging System (ISS) Multiple Myeloma Classification
Stage II
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
International Staging System (ISS) Multiple Myeloma Classification
Stage III
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
International Staging System (ISS) Multiple Myeloma Classification
missing
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Salmon Stage multiple myeloma classification
IA-IB
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Salmon Stage multiple myeloma classification
IIA-IIB
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Salmon Stage multiple myeloma classification
IIIA-IIIB
|
35 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Salmon Stage multiple myeloma classification
missing
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Number of Prior Multiple Myeloma Treatments
|
1 prior treatments
n=5 Participants
|
2 prior treatments
n=7 Participants
|
1 prior treatments
n=5 Participants
|
|
Time to Diagnosis
|
0.53 years
n=5 Participants
|
0.76 years
n=7 Participants
|
0.55 years
n=5 Participants
|
|
Time to stem cell transplant (SCT)
|
63.0 Days
n=5 Participants
|
56.0 Days
n=7 Participants
|
60.0 Days
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 daysPopulation: 71 patients were evaluable in the feasibility set: 70 randomized to the aMILs Arm, plus one patient who was not randomized due to harvest failure.
Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.
Outcome measures
| Measure |
aMIL Arm
n=71 Participants
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Total number who received aMILS
|
71 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Feasible
|
46 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Reason not feasible- failed harvest
|
1 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Reason not feasible- disease progression
|
4 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Reason not feasible- death
|
1 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Reason not feasible- lost to follow-up
|
1 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Reason not feasible- failed expansion
|
2 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Reason not feasible- cell product contamination
|
2 Participants
|
—
|
|
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
Reason not feasible- greater than 120 days
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: 60 days from aMILs harvest until day 60 after transplantTotal number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.
Outcome measures
| Measure |
aMIL Arm
n=70 Participants
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
n=31 Participants
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events
|
129 adverse events
|
65 adverse events
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: This is an analysis by intention-to-treat and only considers transplanted patients randomized to the aMILs arm.
OS assessed by number of participants alive at the end of follow up period.
Outcome measures
| Measure |
aMIL Arm
n=70 Participants
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Overall Survival (OS)
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This is an analysis by intention-to-treat and only considers transplanted patients randomized to the aMILs arm.
Median PFS time equals the time of randomization (in months) until disease progression, death from any cause, or protocol deviation due to lenalidomide dosing (above 10mg), whichever occurs first.
Outcome measures
| Measure |
aMIL Arm
n=70 Participants
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
21.82 months
Interval 18.53 to 41.82
|
—
|
Adverse Events
aMIL Arm
Serious events: 64 serious events
Other events: 11 other events
Deaths: 1 deaths
No aMIL
Serious events: 29 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
aMIL Arm
n=70 participants at risk
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
n=31 participants at risk
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
51.4%
36/70 • Number of events 45 • 60 Days from aMILs harvest until Day 60 after transplant
|
58.1%
18/31 • Number of events 22 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
3/70 • Number of events 3 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.9%
2/70 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.3%
3/70 • Number of events 3 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Metabolism and nutrition disorders
dehydration
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Injury, poisoning and procedural complications
Device related infection
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Gastrointestinal disorders
Diarrhea
|
11.4%
8/70 • Number of events 8 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Infections and infestations
Enterocolitis infection
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
General disorders
Fatigue
|
2.9%
2/70 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
General disorders
fever
|
5.7%
4/70 • Number of events 4 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Nervous system disorders
headache
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Metabolism and nutrition disorders
hypocalcemia
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
5.7%
4/70 • Number of events 5 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Vascular disorders
hypotension
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Infections and infestations
bacteremia
|
4.3%
3/70 • Number of events 3 • 60 Days from aMILs harvest until Day 60 after transplant
|
6.5%
2/31 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Infections and infestations
lung infection
|
2.9%
2/70 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
6.5%
2/31 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Infections and infestations
mucosal infection
|
15.7%
11/70 • Number of events 11 • 60 Days from aMILs harvest until Day 60 after transplant
|
16.1%
5/31 • Number of events 5 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Gastrointestinal disorders
nausea
|
1.4%
1/70 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
6.5%
2/31 • Number of events 3 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
10.0%
7/70 • Number of events 10 • 60 Days from aMILs harvest until Day 60 after transplant
|
9.7%
3/31 • Number of events 4 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Blood and lymphatic system disorders
platelet count decreased
|
4.3%
3/70 • Number of events 7 • 60 Days from aMILs harvest until Day 60 after transplant
|
12.9%
4/31 • Number of events 4 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Renal and urinary disorders
renal calculi
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Infections and infestations
Scrotal Infection
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Infections and infestations
Sepsis
|
2.9%
2/70 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Nervous system disorders
Stroke
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Nervous system disorders
syncope
|
2.9%
2/70 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
6.5%
2/31 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Vascular disorders
thromboembolic event
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Infections and infestations
upper respiratory infection
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Cardiac disorders
ventricular arrhythmia
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/70 • 60 Days from aMILs harvest until Day 60 after transplant
|
6.5%
2/31 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Blood and lymphatic system disorders
white blood cell decreased
|
2.9%
2/70 • Number of events 4 • 60 Days from aMILs harvest until Day 60 after transplant
|
3.2%
1/31 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
Other adverse events
| Measure |
aMIL Arm
n=70 participants at risk
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
|
No aMIL
n=31 participants at risk
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
|
|---|---|---|
|
Product Issues
manufacture failure
|
2.9%
2/70 • Number of events 2 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
Product Issues
product contamination
|
1.4%
1/70 • Number of events 1 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
|
General disorders
infusion related reaction
|
12.7%
8/63 • Number of events 8 • 60 Days from aMILs harvest until Day 60 after transplant
|
0.00%
0/31 • 60 Days from aMILs harvest until Day 60 after transplant
|
Additional Information
Philip Imus, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place