Trial Outcomes & Findings for Lenalidomide and High-Dose Melphalan (NCT NCT01079936)
NCT ID: NCT01079936
Last Updated: 2016-06-06
Results Overview
There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Assessed at 21-28 Day Cycle
Results posted on
2016-06-06
Participant Flow
Recruitment Period: March 01, 2010 to April 18, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
Following Phase I portion of study, participants were assigned using adaptive randomization to 1 of 4 dose levels in Phase II. Out of 61 participants consented, 2 participants were ineligible for study due to first remission status and 2 participants did not receive stem cell transplant due to other issues and are not included in study demographic.
Participant milestones
| Measure |
Phase I: Lenalidomide + High-Dose Melphalan
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
25 Mg Lenalidomide
Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
50 mg Lenalidomide
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|---|
|
Phase I: MTD
STARTED
|
16
|
0
|
0
|
0
|
0
|
|
Phase I: MTD
COMPLETED
|
12
|
0
|
0
|
0
|
0
|
|
Phase I: MTD
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
3
|
6
|
24
|
26
|
|
Phase II
COMPLETED
|
0
|
3
|
5
|
24
|
25
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase I: Lenalidomide + High-Dose Melphalan
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
25 Mg Lenalidomide
Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
50 mg Lenalidomide
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|---|
|
Phase I: MTD
First Remission Status
|
2
|
0
|
0
|
0
|
0
|
|
Phase I: MTD
No Stem Cell Transplantation
|
2
|
0
|
0
|
0
|
0
|
|
Phase II
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Phase II
Insurance Issue
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Lenalidomide and High-Dose Melphalan
Baseline characteristics by cohort
| Measure |
25 Mg Lenalidomide
n=3 Participants
Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
50 mg Lenalidomide
n=6 Participants
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
n=24 Participants
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
n=26 Participants
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
66 years
n=7 Participants
|
55 years
n=5 Participants
|
60 years
n=4 Participants
|
59.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
24 participants
n=5 Participants
|
26 participants
n=4 Participants
|
59 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed at 21-28 Day CyclePopulation: Of the 16 participants in Phase I, two participants were not eligible for study due to first remission status, and two were eligible but did not receive stem cell transplant due to other issues.
There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.
Outcome measures
| Measure |
Lenalidomide + High-Dose Melphalan
n=12 Participants
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
Stem Cell Infusion: Stem cell infusion on Day 0.
|
50 mg Lenalidomide
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Lenalidomide
|
100 mg/day
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 90 after stem cell transplantResponse is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with \<5% plasma cells. There should be \< 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.
Outcome measures
| Measure |
Lenalidomide + High-Dose Melphalan
n=3 Participants
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
Stem Cell Infusion: Stem cell infusion on Day 0.
|
50 mg Lenalidomide
n=5 Participants
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
n=24 Participants
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
n=25 Participants
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Response (CR at Day 90)
|
0 participants
|
0 participants
|
4 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Day 30 following transplantDose limiting toxicity (DLT) was defined as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT.
Outcome measures
| Measure |
Lenalidomide + High-Dose Melphalan
n=3 Participants
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
Stem Cell Infusion: Stem cell infusion on Day 0.
|
50 mg Lenalidomide
n=5 Participants
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
n=24 Participants
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
n=25 Participants
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Day 30 DLT (Overall Study, Phase I/Phase II)
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 90 after stem cell transplantNumber of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.
Outcome measures
| Measure |
Lenalidomide + High-Dose Melphalan
n=3 Participants
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
Stem Cell Infusion: Stem cell infusion on Day 0.
|
50 mg Lenalidomide
n=5 Participants
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
n=24 Participants
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
n=25 Participants
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Participants With Grade 3 =/> Adverse Events
|
3 participants
|
5 participants
|
15 participants
|
17 participants
|
Adverse Events
25 Mg Lenalidomide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg Lenalidomide
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
75 mg Lenalidomide
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
100 mg Lenalidomide
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
25 Mg Lenalidomide
n=3 participants at risk
Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
50 mg Lenalidomide
n=6 participants at risk
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
n=24 participants at risk
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
n=26 participants at risk
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood Platelets
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/24 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
3.8%
1/26 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
4.2%
1/24 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/26 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
Other adverse events
| Measure |
25 Mg Lenalidomide
n=3 participants at risk
Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
50 mg Lenalidomide
n=6 participants at risk
Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
75 mg Lenalidomide
n=24 participants at risk
Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
100 mg Lenalidomide
n=26 participants at risk
Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Change in Platelet levels
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/24 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
3.8%
1/26 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Cardiac disorders
High blood pressure
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
8.3%
2/24 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
7.7%
2/26 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
8.3%
2/24 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
11.5%
3/26 • Number of events 3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
37.5%
9/24 • Number of events 9 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
50.0%
13/26 • Number of events 13 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Gastrointestinal disorders
Herpetic lip leson
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
4.2%
1/24 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/26 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Renal and urinary disorders
Creatinine increased
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
8.3%
2/24 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
7.7%
2/26 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Renal and urinary disorders
GU HEM
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
4.2%
1/24 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/26 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Renal and urinary disorders
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
16.7%
4/24 • Number of events 4 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
3.8%
1/26 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Renal and urinary disorders
Hepatobiliary disorders
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
16.7%
1/6 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
16.7%
4/24 • Number of events 4 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
11.5%
3/26 • Number of events 3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
33.3%
2/6 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
8.3%
2/24 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
42.3%
11/26 • Number of events 11 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Nervous system disorders
Other Neurologic Disorder
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/24 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
3.8%
1/26 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/24 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
3.8%
1/26 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Effusion
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
8.3%
2/24 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/26 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
16.7%
1/6 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
8.3%
2/24 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
11.5%
3/26 • Number of events 3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Skin and subcutaneous tissue disorders
Other Skin Disorder
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
4.2%
1/24 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/26 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
12.5%
3/24 • Number of events 3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
15.4%
4/26 • Number of events 4 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
General disorders
Fever, Flu-like
|
33.3%
1/3 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
0.00%
0/6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
20.8%
5/24 • Number of events 5 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
11.5%
3/26 • Number of events 3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
100.0%
6/6 • Number of events 6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
91.7%
22/24 • Number of events 22 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
80.8%
21/26 • Number of events 21 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Gastrointestinal disorders
GI DPH
|
66.7%
2/3 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
66.7%
4/6 • Number of events 4 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
41.7%
10/24 • Number of events 10 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
50.0%
13/26 • Number of events 13 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Infections and infestations
Infection, Neutropenic fever
|
66.7%
2/3 • Number of events 2 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
83.3%
5/6 • Number of events 5 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
37.5%
9/24 • Number of events 9 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
57.7%
15/26 • Number of events 15 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 3 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
100.0%
6/6 • Number of events 6 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
91.7%
22/24 • Number of events 22 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
96.2%
25/26 • Number of events 25 • Adverse event collection from the start of preparative regiment up to Day 30 following stem cell transplant.
|
Additional Information
Muzaffar H. Qazilbash, Professor, Stem Cell Transplantation
University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place