Trial Outcomes & Findings for Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma (NCT NCT00185614)
NCT ID: NCT00185614
Last Updated: 2018-01-18
Results Overview
Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
3 years
Results posted on
2018-01-18
Participant Flow
Participant milestones
| Measure |
Auto- Then Allo-HCT
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Autologous HCT (Auto-HCT)
STARTED
|
63
|
|
Autologous HCT (Auto-HCT)
COMPLETED
|
63
|
|
Autologous HCT (Auto-HCT)
NOT COMPLETED
|
0
|
|
Inter-treatment Period
STARTED
|
63
|
|
Inter-treatment Period
COMPLETED
|
59
|
|
Inter-treatment Period
NOT COMPLETED
|
4
|
|
Allogenic HCT (Allo-HCT)
STARTED
|
59
|
|
Allogenic HCT (Allo-HCT)
COMPLETED
|
59
|
|
Allogenic HCT (Allo-HCT)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Auto- Then Allo-HCT
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Inter-treatment Period
Physician Decision
|
1
|
|
Inter-treatment Period
Relapse
|
2
|
|
Inter-treatment Period
Lack of allogenic donor
|
1
|
Baseline Characteristics
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Auto- Then Allo-HCT
n=63 Participants
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").
Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.
Outcome measures
| Measure |
Auto- Then Allo-HCT
n=63 Participants
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Event-free Survival (EFS)
Auto-HCT only
|
0 Participants
|
|
Event-free Survival (EFS)
Auto-HCT then Allo-HCT
|
24 Participants
|
|
Event-free Survival (EFS)
All Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The outcome data are reported as the number of participants who relapse per criteria within 3 years.
Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein \>25%; bone marrow plasmacytosis \>25%; or bone lesions on skeletal survey (any increase).
Outcome measures
| Measure |
Auto- Then Allo-HCT
n=63 Participants
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Relapse Rate
All Participants
|
31 participants
|
|
Relapse Rate
Auto-HCT only
|
2 participants
|
|
Relapse Rate
Auto-HCT then Allo-HCT
|
29 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The outcome data are reported as the number of participants who could be documented as remaining alive through 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").
Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.
Outcome measures
| Measure |
Auto- Then Allo-HCT
n=63 Participants
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Overall Survival (OS)
Auto-HCT only
|
1 participants
|
|
Overall Survival (OS)
Auto-HCT then Allo-HCT
|
41 participants
|
|
Overall Survival (OS)
All Participants
|
42 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT, as determined by investigator judgement (no protocol-specified criteria).
Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.
Outcome measures
| Measure |
Auto- Then Allo-HCT
n=59 Participants
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Acute Graft-vs-Host-Disease (aGvHD)
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT.
Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria).
Outcome measures
| Measure |
Auto- Then Allo-HCT
n=59 Participants
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Chronic Graft-vs-Host-Disease (cGvHD)
Extensive cGvHD
|
30 Participants
|
|
Chronic Graft-vs-Host-Disease (cGvHD)
cGvHD, not Extensive
|
8 Participants
|
|
Chronic Graft-vs-Host-Disease (cGvHD)
No cGvHD
|
21 Participants
|
Adverse Events
All Participants Receviing at Least Auto-HCT
Serious events: 63 serious events
Other events: 63 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
All Participants Receviing at Least Auto-HCT
n=63 participants at risk
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung Aspergillosis
|
1.6%
1/63 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Failure
|
4.8%
3/63 • Number of events 3 • 3 years
|
|
Cardiac disorders
Heart Failure
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiopulmonary Failure
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Aseptic Encephalitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Infections and infestations
Bacteremia
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Immune system disorders
Cytomegalovirus
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Coagulase-negative staphylococci
|
4.8%
3/63 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Disseminated varicella zoster
|
6.3%
4/63 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Erosive esophagitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Infections and infestations
Febrile Neutropenia
|
49.2%
31/63 • Number of events 31 • 3 years
|
|
Infections and infestations
Fever
|
4.8%
3/63 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
Fungemia
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Gram-negative bacillary bacteremia
|
9.5%
6/63 • Number of events 6 • 3 years
|
|
Nervous system disorders
Herpetic stomatitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Hyponatremia
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Infections and infestations
Klebsiella bacteremia
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Mucositis
|
12.7%
8/63 • Number of events 8 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
6.3%
4/63 • Number of events 4 • 3 years
|
|
Blood and lymphatic system disorders
Platelet count decrease
|
4.8%
3/63 • Number of events 4 • 3 years
|
|
Infections and infestations
Pneumonia
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Pseudomonas bacteremia
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal Failure
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyositis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Right Parietal Encephalocele
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncytial virus pneumonitis
|
7.9%
5/63 • Number of events 5 • 3 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Cardiac disorders
Superior Vena Cava Syndrome
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Infections and infestations
Viral Pneumonitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
All Participants Receviing at Least Auto-HCT
n=63 participants at risk
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Ascites
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Infections and infestations
Bacteremia
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Infections and infestations
Clostridium Difficile Colitis
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Immune system disorders
Cytomegalovirus
|
7.9%
5/63 • Number of events 6 • 3 years
|
|
Blood and lymphatic system disorders
Coagulase-negative staphylococci
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
General disorders
Dehyration
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Disseminated varicella zoster
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Infections and infestations
Febrile neutropenia
|
7.9%
5/63 • Number of events 5 • 3 years
|
|
Infections and infestations
Fever
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Nervous system disorders
Herpes Zoster
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash
|
9.5%
6/63 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Mucositis
|
9.5%
6/63 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
11.1%
7/63 • Number of events 7 • 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.4%
16/63 • Number of events 17 • 3 years
|
|
Infections and infestations
Parainfluenza pneumonitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Platelet count decrease
|
22.2%
14/63 • Number of events 15 • 3 years
|
|
Renal and urinary disorders
Renal Failure
|
23.8%
15/63 • Number of events 16 • 3 years
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Steroid Myopathy
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Transaminitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
3.2%
2/63 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Viral bronchitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
|
Infections and infestations
Viral Pneumonitis
|
1.6%
1/63 • Number of events 1 • 3 years
|
Additional Information
Wen-Kai Weng, MD; Associate Professor of Medicine
Stanford University School of Medicine
Phone: 650-723-7689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place