Trial Outcomes & Findings for Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma (NCT NCT02506959)
NCT ID: NCT02506959
Last Updated: 2025-03-18
Results Overview
Number of participants alive and disease free one year post auto transplant in patients with refractory or relapsed myeloma receiving panobinostat/gemcitabine/busulfan/melphalan (panobinostat/Gem/Bu/Mel) with autologous stem-cell transplant, either as a first or a salvage stem-cell transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
1 year
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
33
|
|
Overall Study
COMPLETED
|
48
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=50 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=33 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of participants alive and disease free one year post auto transplant in patients with refractory or relapsed myeloma receiving panobinostat/gemcitabine/busulfan/melphalan (panobinostat/Gem/Bu/Mel) with autologous stem-cell transplant, either as a first or a salvage stem-cell transplant.
Outcome measures
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=50 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=33 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Progression Free Survival (PFS)
|
38 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsNumber of participants with refractory or relapse Myeloma who still remain alive two years post transplant
Outcome measures
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=50 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=33 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Overall Survival (OS)
|
27 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to day 100Number of Participants who experienced grade 3 or higher Adverse Events during the first 100 days of the transplant.
Outcome measures
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=50 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=33 Participants
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Participants Who Experienced Grade 3 or Higher Adverse Events
|
47 Participants
|
29 Participants
|
Adverse Events
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
Serious events: 2 serious events
Other events: 47 other events
Deaths: 23 deaths
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
Serious events: 4 serious events
Other events: 30 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=50 participants at risk
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=33 participants at risk
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Investigations
AST increased
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Bleeding (no GI no PUL)
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
DAH
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Fungal
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
6.1%
2/33 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Oral mucositis
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.0%
2/50 • Number of events 2 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Investigations
T bilirubin increased
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Viral
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
12.1%
4/33 • Number of events 4 • Up to 2 years
|
Other adverse events
| Measure |
Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=50 participants at risk
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel
n=33 participants at risk
Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Busulfan: Given IV
Gemcitabine Hydrochloride: Given IV
Melphalan: Given IV
Panobinostat: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo autologous peripheral blood stem cell transplant
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
6.1%
2/33 • Number of events 2 • Up to 2 years
|
|
Investigations
ALK increased
|
4.0%
2/50 • Number of events 2 • Up to 2 years
|
9.1%
3/33 • Number of events 3 • Up to 2 years
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Investigations
ALT increased
|
50.0%
25/50 • Number of events 25 • Up to 2 years
|
60.6%
20/33 • Number of events 20 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Investigations
AST increased
|
20.0%
10/50 • Number of events 10 • Up to 2 years
|
18.2%
6/33 • Number of events 6 • Up to 2 years
|
|
Infections and infestations
Bacterial
|
36.0%
18/50 • Number of events 18 • Up to 2 years
|
42.4%
14/33 • Number of events 14 • Up to 2 years
|
|
Blood and lymphatic system disorders
Bleeding (no GI no PUL)
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
CD OTH
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Investigations
Creatinine increased
|
14.0%
7/50 • Number of events 7 • Up to 2 years
|
18.2%
6/33 • Number of events 6 • Up to 2 years
|
|
General disorders
Diarrhea
|
86.0%
43/50 • Number of events 43 • Up to 2 years
|
84.8%
28/33 • Number of events 28 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
6.0%
3/50 • Number of events 3 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Gastrointestinal disorders
Dysgeusia
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Dysrhythmia
|
20.0%
10/50 • Number of events 10 • Up to 2 years
|
21.2%
7/33 • Number of events 7 • Up to 2 years
|
|
Cardiac disorders
Ejection fraction decreased
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Immune system disorders
Engraftment syndrome
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
6.1%
2/33 • Number of events 2 • Up to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
86.0%
43/50 • Number of events 43 • Up to 2 years
|
84.8%
28/33 • Number of events 28 • Up to 2 years
|
|
General disorders
Fever
|
22.0%
11/50 • Number of events 11 • Up to 2 years
|
21.2%
7/33 • Number of events 7 • Up to 2 years
|
|
General disorders
Fluid overload
|
72.0%
36/50 • Number of events 36 • Up to 2 years
|
75.8%
25/33 • Number of events 25 • Up to 2 years
|
|
Infections and infestations
Fungal
|
6.0%
3/50 • Number of events 3 • Up to 2 years
|
6.1%
2/33 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
GI OTH
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Headache
|
8.0%
4/50 • Number of events 4 • Up to 2 years
|
9.1%
3/33 • Number of events 3 • Up to 2 years
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
9.1%
3/33 • Number of events 3 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
20.0%
10/50 • Number of events 10 • Up to 2 years
|
27.3%
9/33 • Number of events 9 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
6.0%
3/50 • Number of events 3 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
92.0%
46/50 • Number of events 46 • Up to 2 years
|
90.9%
30/33 • Number of events 30 • Up to 2 years
|
|
Nervous system disorders
NE OTH
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Nervous system disorders
NE VIS
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Oral mucositis
|
94.0%
47/50 • Number of events 47 • Up to 2 years
|
78.8%
26/33 • Number of events 26 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
16.0%
8/50 • Number of events 8 • Up to 2 years
|
9.1%
3/33 • Number of events 3 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.0%
3/50 • Number of events 3 • Up to 2 years
|
15.2%
5/33 • Number of events 5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
54.0%
27/50 • Number of events 27 • Up to 2 years
|
69.7%
23/33 • Number of events 23 • Up to 2 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/50 • Up to 2 years
|
3.0%
1/33 • Number of events 1 • Up to 2 years
|
|
Investigations
T bilirubin increased
|
30.0%
15/50 • Number of events 15 • Up to 2 years
|
36.4%
12/33 • Number of events 12 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
6.0%
3/50 • Number of events 3 • Up to 2 years
|
6.1%
2/33 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
2.0%
1/50 • Number of events 1 • Up to 2 years
|
0.00%
0/33 • Up to 2 years
|
|
Infections and infestations
Viral
|
36.0%
18/50 • Number of events 18 • Up to 2 years
|
69.7%
23/33 • Number of events 23 • Up to 2 years
|
Additional Information
Yago Nieto, MD / Stem Cell Transplantation Department
The University of Texas MD Anderson Cancer Center
Phone: 713-792-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place