Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Study Details
Study Description
Brief Summary
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Participants are mobilized with cyclophosphamide 4 g/m2 and 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 includes filgrastim 5 µg/kg/day, starting 6 days following melphalan. Participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic HCT (allo-HCT). For allo-HCT, a sibling donor that is fully matched for human leukocyte antigen (HLA-matched) is identified. Participants receive a single dose of total body irradiation (TBI) 200 centigray (cGy) as well as immunosuppression with cyclosporine (CSP) 6.25 mg/kg and mycophenolate mofetil (MMF) 15 mg/kg. The HLA-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to Day 0, with apheresis collections on Day -1 and 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 and diphenhydramine 50 mg IV. CSP will be tapered beginning Day 56 with a goal of discontinuing CSP on Day 180, adjusted as needed.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Procedure: Autologous hematopoietic cell transplant (Auto-HCT)
The target cell dose is 2.6 x 10e6 CD34+ cells/kg
Procedure: Allogeneic hematopoietic cell transplant (Allo-HCT)
The target cell dose is 5 x 10e6 CD34 cells/kg
Drug: Cyclophosphamide
Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
Other Names:
Drug: Filgrastim
Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT)
Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT)
Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)
Other Names:
Drug: Melphalan
Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
Other Names:
Radiation: Total body irradiation (TBI)
200 centigray (cGy) total body irradiation delivered on Day 0
Procedure: Cyclosporine (CSP)
Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
Other Names:
Drug: Mycophenolate Mofetil (MMF)
Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Event-free Survival (EFS) [3 years]
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.
Secondary Outcome Measures
- Relapse Rate [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).
- Overall Survival (OS) [3 years]
Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.
- Acute Graft-vs-Host-Disease (aGvHD) [6 months]
Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.
- Chronic Graft-vs-Host-Disease (cGvHD) [3 years]
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).
Eligibility Criteria
Criteria
PATIENT INCLUSION CRITERIA
-
Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease
-
Patient has HLA-identical sibling donor
-
Age ≤ 70 years
-
No prior therapy which would preclude the use of low-dose total body irradiation
-
Pathology review and diagnosis confirmation by Stanford University Medical Center
-
Karnofsky performance status (KPS) > 70%
-
DLCO ≥ 60% predicted
-
ALT and AST < 2 x upper limit of normal (ULN)
-
Total bilirubin < 2 mg/dL
-
Serum creatinine < 2.0, or 24-hour creatinine clearance ≥ 60 mL/min
-
HIV-negative
-
Signed informed consent document
PATIENT EXCLUSION CRITERIA
-
Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis
-
Severe psychological or medical illness
-
Prior allogeneic hematopoietic cell transplantation
-
Pregnant or lactating
ALLOGENEIC DONOR INCLUSION CRITERIA
-
Age ≥ 17
-
HIV-seronegative
-
Signed informed consent document
ALLOGENEIC DONOR EXCLUSION CRITERIA
-
Serious medical or psychological illness
-
Pregnant or lactating
-
Prior malignancies within the last 5 years, except for non-melanoma skin cancers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Wen-Kai Weng
Investigators
- Principal Investigator: Wen-Kai Weng, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-13378
- 75190
- BMT109
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Auto- Then Allo-HCT |
---|---|
Arm/Group Description | 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. |
Period Title: Autologous HCT (Auto-HCT) | |
STARTED | 63 |
COMPLETED | 63 |
NOT COMPLETED | 0 |
Period Title: Autologous HCT (Auto-HCT) | |
STARTED | 63 |
COMPLETED | 59 |
NOT COMPLETED | 4 |
Period Title: Autologous HCT (Auto-HCT) | |
STARTED | 59 |
COMPLETED | 59 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Auto- Then Allo-HCT |
---|---|
Arm/Group Description | 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 Participants | 63 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
60
95.2%
|
>=65 years |
3
4.8%
|
Sex: Female, Male (Count of Participants) | |
Female |
20
31.7%
|
Male |
43
68.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
5
7.9%
|
Not Hispanic or Latino |
43
68.3%
|
Unknown or Not Reported |
15
23.8%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
7
11.1%
|
Native Hawaiian or Other Pacific Islander |
3
4.8%
|
Black or African American |
5
7.9%
|
White |
43
68.3%
|
More than one race |
0
0%
|
Unknown or Not Reported |
5
7.9%
|
Outcome Measures
Title | Event-free Survival (EFS) |
---|---|
Description | 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. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
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"). |
Arm/Group Title | Auto- Then Allo-HCT |
---|---|
Arm/Group Description | 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. |
Measure Participants | 63 |
Auto-HCT only |
0
0%
|
Auto-HCT then Allo-HCT |
24
38.1%
|
All Participants |
24
38.1%
|
Title | Relapse Rate |
---|---|
Description | 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). |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
The outcome data are reported as the number of participants who relapse per criteria within 3 years. |
Arm/Group Title | Auto- Then Allo-HCT |
---|---|
Arm/Group Description | 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. |
Measure Participants | 63 |
Auto-HCT only |
2
3.2%
|
Auto-HCT then Allo-HCT |
29
46%
|
All Participants |
31
49.2%
|
Title | Overall Survival (OS) |
---|---|
Description | Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
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"). |
Arm/Group Title | Auto- Then Allo-HCT |
---|---|
Arm/Group Description | 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. |
Measure Participants | 63 |
Auto-HCT only |
1
1.6%
|
Auto-HCT then Allo-HCT |
41
65.1%
|
All Participants |
42
66.7%
|
Title | Acute Graft-vs-Host-Disease (aGvHD) |
---|---|
Description | Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT. |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT, as determined by investigator judgement (no protocol-specified criteria). |
Arm/Group Title | Auto- Then Allo-HCT |
---|---|
Arm/Group Description | 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. |
Measure Participants | 59 |
Count of Participants [Participants] |
7
11.1%
|
Title | Chronic Graft-vs-Host-Disease (cGvHD) |
---|---|
Description | 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). |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT. |
Arm/Group Title | Auto- Then Allo-HCT |
---|---|
Arm/Group Description | 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. |
Measure Participants | 59 |
Extensive cGvHD |
30
47.6%
|
cGvHD, not Extensive |
8
12.7%
|
No cGvHD |
21
33.3%
|
Adverse Events
Time Frame | 3 years | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | All Participants Receviing at Least Auto-HCT | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
All Participants Receviing at Least Auto-HCT | ||
Affected / at Risk (%) | # Events | |
Total | 21/63 (33.3%) | |
Serious Adverse Events |
||
All Participants Receviing at Least Auto-HCT | ||
Affected / at Risk (%) | # Events | |
Total | 63/63 (100%) | |
Blood and lymphatic system disorders | ||
Coagulase-negative staphylococci | 3/63 (4.8%) | 3 |
Fungemia | 1/63 (1.6%) | 1 |
Gram-negative bacillary bacteremia | 6/63 (9.5%) | 6 |
Hyponatremia | 1/63 (1.6%) | 1 |
Platelet count decrease | 3/63 (4.8%) | 4 |
Pseudomonas bacteremia | 1/63 (1.6%) | 1 |
Cardiac disorders | ||
Heart Failure | 1/63 (1.6%) | 1 |
Cardiopulmonary Failure | 2/63 (3.2%) | 2 |
Supraventricular tachycardia | 1/63 (1.6%) | 1 |
Superior Vena Cava Syndrome | 1/63 (1.6%) | 1 |
Gastrointestinal disorders | ||
Diarrhea | 2/63 (3.2%) | 2 |
Erosive esophagitis | 1/63 (1.6%) | 1 |
Mucositis | 8/63 (12.7%) | 8 |
Nausea | 4/63 (6.3%) | 4 |
Immune system disorders | ||
Cytomegalovirus | 2/63 (3.2%) | 2 |
Infections and infestations | ||
Bacteremia | 2/63 (3.2%) | 2 |
Febrile Neutropenia | 31/63 (49.2%) | 31 |
Fever | 3/63 (4.8%) | 3 |
Klebsiella bacteremia | 1/63 (1.6%) | 1 |
Pneumonia | 2/63 (3.2%) | 2 |
Viral Pneumonitis | 1/63 (1.6%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Myopathy | 1/63 (1.6%) | 1 |
Rhabdomyositis | 1/63 (1.6%) | 1 |
Right Parietal Encephalocele | 1/63 (1.6%) | 1 |
Nervous system disorders | ||
Herpetic stomatitis | 1/63 (1.6%) | 1 |
Psychiatric disorders | ||
Aseptic Encephalitis | 1/63 (1.6%) | 1 |
Renal and urinary disorders | ||
Acute Kidney Injury | 1/63 (1.6%) | 1 |
Renal Failure | 1/63 (1.6%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Lung Aspergillosis | 1/63 (1.6%) | 1 |
Pulmonary Failure | 3/63 (4.8%) | 3 |
Lung Aspergillosis | 1/63 (1.6%) | 2 |
Respiratory syncytial virus pneumonitis | 5/63 (7.9%) | 5 |
Skin and subcutaneous tissue disorders | ||
Disseminated varicella zoster | 4/63 (6.3%) | 4 |
Other (Not Including Serious) Adverse Events |
||
All Participants Receviing at Least Auto-HCT | ||
Affected / at Risk (%) | # Events | |
Total | 63/63 (100%) | |
Blood and lymphatic system disorders | ||
Coagulase-negative staphylococci | 1/63 (1.6%) | 1 |
Neutropenia | 16/63 (25.4%) | 17 |
Platelet count decrease | 14/63 (22.2%) | 15 |
Transaminitis | 1/63 (1.6%) | 1 |
Thrombotic Thrombocytopenic Purpura | 2/63 (3.2%) | 2 |
Gastrointestinal disorders | ||
Colitis | 1/63 (1.6%) | 1 |
Diarrhea | 1/63 (1.6%) | 1 |
Gastritis | 1/63 (1.6%) | 1 |
Mucositis | 6/63 (9.5%) | 6 |
Nausea | 7/63 (11.1%) | 7 |
Steroid Myopathy | 1/63 (1.6%) | 1 |
General disorders | ||
Dehyration | 1/63 (1.6%) | 1 |
Immune system disorders | ||
Cytomegalovirus | 5/63 (7.9%) | 6 |
Infections and infestations | ||
Bacteremia | 1/63 (1.6%) | 1 |
Clostridium Difficile Colitis | 2/63 (3.2%) | 2 |
Febrile neutropenia | 5/63 (7.9%) | 5 |
Fever | 2/63 (3.2%) | 2 |
Parainfluenza pneumonitis | 1/63 (1.6%) | 1 |
Viral Pneumonitis | 1/63 (1.6%) | 1 |
Nervous system disorders | ||
Herpes Zoster | 1/63 (1.6%) | 1 |
Renal and urinary disorders | ||
Acute Kidney Injury | 1/63 (1.6%) | 1 |
Ascites | 1/63 (1.6%) | 1 |
Renal Failure | 15/63 (23.8%) | 16 |
Respiratory, thoracic and mediastinal disorders | ||
Viral bronchitis | 1/63 (1.6%) | 1 |
Skin and subcutaneous tissue disorders | ||
Cellulitis | 1/63 (1.6%) | 1 |
Disseminated varicella zoster | 2/63 (3.2%) | 2 |
Maculo-papular rash | 6/63 (9.5%) | 6 |
Seborrheic dermatitis | 1/63 (1.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Wen-Kai Weng, MD; Associate Professor of Medicine |
---|---|
Organization | Stanford University School of Medicine |
Phone | 650-723-7689 |
wkweng@stanford.edu |
- IRB-13378
- 75190
- BMT109