Trial Outcomes & Findings for Autologous Transplant for Multiple Myeloma (NCT NCT00177047)
NCT ID: NCT00177047
Last Updated: 2021-11-09
Results Overview
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
COMPLETED
PHASE2/PHASE3
363 participants
100 Days post transplant
2021-11-09
Participant Flow
Participant milestones
| Measure |
Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
|
|---|---|
|
Overall Study
STARTED
|
363
|
|
Overall Study
COMPLETED
|
363
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous Transplant for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
257 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
313 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
304 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
363 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 Days post transplantPopulation: 173 participants were not evaluable
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=190 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants Achieving a Complete Response
|
51 Participants
|
PRIMARY outcome
Timeframe: 6 months post transplantPopulation: 54 participants were not evaluable
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=309 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
|
Number of Participants Achieving a Complete Response
|
99 Participants
|
PRIMARY outcome
Timeframe: 12 months post transplantPopulation: 55 participants were not evaluable
Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=308 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants Achieving a Complete Response
|
123 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsExtended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Patients With Extended Disease-free Survival
|
164 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants With Overall Survival
|
349 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants With Overall Survival
|
328 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants With Overall Survival
|
301 Participants
|
SECONDARY outcome
Timeframe: 1 yearIn the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Count of Participants Experiencing Transplant Related Mortality
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe return of disease after its apparent recovery/cessation.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants Experiencing Incidence of Relapse
|
69 Participants
|
SECONDARY outcome
Timeframe: 1 yearMyeloma Response Definitions - Using International Uniform Response Criteria: Progressive Disease (PD) For patients not in CR or sCR, progressive disease requires one or more of the following: * \>25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL. * \>25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours. * Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl), only in patients without measurable paraprotein in the serum and urine. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants With Disease Progression
|
34 Participants
|
SECONDARY outcome
Timeframe: 1 yearMean number of days among patients progressing
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=34 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Time to Progression
|
159.4 Days
Standard Deviation 109.8
|
SECONDARY outcome
Timeframe: 1 yearMean number of days among patients relapsing
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=69 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Time to Relapse
|
182.9 Days
Standard Deviation 113.5
|
SECONDARY outcome
Timeframe: Day 42Hematologic recovery is defined by absolute neutrophil count (ANC) \>2500/μl and platelets \> 100,000/μl
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants With Absolute Neutrophil Recovery
|
363 Participants
|
SECONDARY outcome
Timeframe: 12 months post transplantPopulation: Data was not available on everyone for this endpoint so could only evaluable for 308 out of 363 patients due to data for participants is not available as the EPIC system was not in place when this study was conducted and participants moved to different clinics we do not have follow-up details.
Mean (STD) among patients achieving complete remission (CR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=308 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
|
|---|---|
|
Time to Attainment of CR
|
4.6 months
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 months post transplantPopulation: 55 patients were not evaluable Data was not available on everyone for this endpoint so could not evaluate all 363 patients
Mean (STD) among patients achieving complete remission (CR) and partial remission (PR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas. Partial Response (PR): * Greater than or equal to 50% reduction in the level of the serum monoclonal paraprotein and/or reduction in 24 hour urinary monoclonal paraprotein either by greater than or equal to 90% or to \<200 mg/24 hours in light chain disease. * If the only measurable non-bone marrow parameter is FLC, greater than or equal to 50% reduction in the difference between involved and uninvolved FLC levels or a 50% decrease in level
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=308 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Time to Attainment of CR+PR
|
4.3 months
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: During studyPopulation: Data not available for this outcome at our center, maintenance treatment data for participants is not available as the EPIC system was not in place when this study was conducted and participants moved to different clinics so follow-up details were no available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post transplant phasePopulation: Data not available for this outcome at our center, maintenance treatment data for participants is not available as the EPIC system was not in place when this study was conducted and participants moved to different clinics so follow-up details were no available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: By first 100 daysOccurrence of toxicities by first 100 days of transplant
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
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Number of Participants With Toxicities
|
68 Participants
|
SECONDARY outcome
Timeframe: By first 100 daysOccurrence of infections in the patients by the first 100 days of transplant
Outcome measures
| Measure |
Chemotherapy and Transplant Treatment
n=363 Participants
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
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|---|---|
|
Number of Participants With Infections
|
68 Participants
|
Adverse Events
Chemotherapy and Transplant Treatment
Serious adverse events
| Measure |
Chemotherapy and Transplant Treatment
n=363 participants at risk
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
Stem Cell Transplant: As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
Cyclophosphamide + Mesna: Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
Melphalan: Administered intravenously 200 mg/m\^2
Granulocyte-colony stimulating factor: Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
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|---|---|
|
Investigations
M-spike increase
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
GI bleeding
|
0.28%
1/363 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Chemotherapy and Transplant Treatment
n=363 participants at risk
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
Stem Cell Transplant: As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
Cyclophosphamide + Mesna: Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
Melphalan: Administered intravenously 200 mg/m\^2
Granulocyte-colony stimulating factor: Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
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|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
4/363 • Number of events 4 • 3 years
|
|
Nervous system disorders
Akinesis
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Edema
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.28%
1/363 • Number of events 2 • 3 years
|
|
Cardiac disorders
Artrial fibrillation
|
2.2%
8/363 • Number of events 8 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Vascular disorders
Blood clot
|
0.83%
3/363 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
bowl obstruction
|
1.4%
5/363 • Number of events 5 • 3 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Eye disorders
Cataract
|
1.1%
4/363 • Number of events 4 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Chest opacities
|
0.28%
1/363 • Number of events 3 • 3 years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Cardiac disorders
Congestive heart failure
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Investigations
Elevated troponin
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Emphysema
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
Encephalopathy
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
General disorders
Engraftment syndrome
|
1.4%
5/363 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Epigastric pain
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Eye disorders
Eye hemorrhage
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
GI bleed
|
2.2%
8/363 • Number of events 8 • 3 years
|
|
Gastrointestinal disorders
GI toxicity
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Immune system disorders
Gout
|
0.83%
3/363 • Number of events 3 • 3 years
|
|
Psychiatric disorders
Hallucinations
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Ear and labyrinth disorders
Hearing loss
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Cardiac disorders
Heart abnormality
|
0.28%
1/363 • Number of events 2 • 3 years
|
|
Vascular disorders
Hemorrhage
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Hernia
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Investigations
Hypercalcemia
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypertension
|
1.4%
5/363 • Number of events 5 • 3 years
|
|
Vascular disorders
Hypotension
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Investigations
Hypothyroidism
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection
|
38.6%
140/363 • Number of events 246 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Intubation
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Surgical and medical procedures
Left hio hemiarhroplasty
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Cardiac disorders
Left vertricular hypertrophy
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
Liver parenchymal disease
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Cardiac disorders
Low Ejection fraction
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Eye disorders
Macular degeneration
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.9%
7/363 • Number of events 8 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle tear
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Nervous system disorders
Neuropathy
|
4.1%
15/363 • Number of events 15 • 3 years
|
|
Nervous system disorders
Neurotoxicity
|
0.83%
3/363 • Number of events 3 • 3 years
|
|
Eye disorders
Ocular muscle fatigue
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
4/363 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Physical Deconditioning
|
0.83%
3/363 • Number of events 3 • 3 years
|
|
Cardiac disorders
Plueral effusions
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Infections and infestations
Pneumonia
|
14.9%
54/363 • Number of events 77 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
3/363 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rashes
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal calculus
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal insufficiency
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Infections and infestations
Sepsis
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
skin; stevens Johnson syndrome
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Cardiac disorders
stent placement for occlusion
|
0.28%
1/363 • Number of events 1 • 3 years
|
|
Cardiac disorders
Tachycardia
|
2.5%
9/363 • Number of events 9 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.55%
2/363 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Thrombosis
|
3.3%
12/363 • Number of events 12 • 3 years
|
|
Investigations
Transminitis
|
0.28%
1/363 • Number of events 1 • 3 years
|
Additional Information
Dr.Claudio G. Brunstein MD, PhD
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place