Trial Outcomes & Findings for Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma (NCT NCT00006184)
NCT ID: NCT00006184
Last Updated: 2017-10-20
Results Overview
Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) \> 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
105 days
Results posted on
2017-10-20
Participant Flow
Participant milestones
| Measure |
Recipient - Chemotherapy Group
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
|
Donor - Vaccination Generation Group
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Recipient - Chemotherapy Group
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
|
Donor - Vaccination Generation Group
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Recipient - Chemotherapy Group
n=10 Participants
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
|
Donor - Vaccination Generation Group
n=10 Participants
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
|
Total
n=20 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 4.59 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 6.05 • n=7 Participants
|
52. years
STANDARD_DEVIATION 5.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 105 daysPopulation: This outcome measure was only pre-specified to be measured in the recipient Arm/Group.
Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) \> 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.
Outcome measures
| Measure |
Recipient - Chemotherapy Group
n=10 Participants
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
|
Donor - Vaccination Generation Group
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
|
|---|---|---|
|
Immune Response
|
7 Particpants
|
—
|
PRIMARY outcome
Timeframe: 9 yearsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Recipient - Chemotherapy Group
n=10 Participants
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
|
Donor - Vaccination Generation Group
n=10 Participants
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
|
|---|---|---|
|
Number of Participants With Adverse Events
|
10 Participants
|
10 Participants
|
Adverse Events
Recipient - Chemotherapy Group
Serious events: 10 serious events
Other events: 10 other events
Deaths: 0 deaths
Donor - Vaccination Generation Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Recipient - Chemotherapy Group
n=10 participants at risk
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
|
Donor - Vaccination Generation Group
n=10 participants at risk
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
3/10 • Number of events 3 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Diarrhea (without colostomy)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection without neutropenia
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Leukocytes (total WBC)
|
60.0%
6/10 • Number of events 13 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Leukocytes (total WBC) for BMT
|
40.0%
4/10 • Number of events 4 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Metabolic-Other (GGT)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Psychiatric disorders
Mood alteration::Depression
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Nausea and vomiting
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Nervous system disorders
Neurologic-Other (Neuropathy)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
70.0%
7/10 • Number of events 16 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC) for BMT
|
80.0%
8/10 • Number of events 10 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Platelets
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Platelets for BMT
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
SGOT (AST)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
SGPT (ALT)
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Transfusion: Platelets
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
Other adverse events
| Measure |
Recipient - Chemotherapy Group
n=10 participants at risk
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
|
Donor - Vaccination Generation Group
n=10 participants at risk
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
20.0%
2/10 • Number of events 3 • 9 years
|
30.0%
3/10 • Number of events 3 • 9 years
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Alkaline phosphatase
|
30.0%
3/10 • Number of events 6 • 9 years
|
20.0%
2/10 • Number of events 2 • 9 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
20.0%
2/10 • Number of events 4 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Immune system disorders
Allergy - Other (Transfusion reaction (platelets)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Amylase
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Bilirubin
|
40.0%
4/10 • Number of events 11 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Bilirubin - graft versus host disease (GVHD)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
60.0%
6/10 • Number of events 17 • 9 years
|
30.0%
3/10 • Number of events 6 • 9 years
|
|
Eye disorders
Cataract
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Catheter-related infection
|
40.0%
4/10 • Number of events 5 • 9 years
|
0.00%
0/10 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Chest pain (non-cardiac and non-pleuritic)
|
20.0%
2/10 • Number of events 2 • 9 years
|
30.0%
3/10 • Number of events 3 • 9 years
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Number of events 5 • 9 years
|
10.0%
1/10 • Number of events 2 • 9 years
|
|
General disorders
Constitutional Symptoms-Other (CGVHD-skin)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
5/10 • Number of events 5 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Creatinine
|
70.0%
7/10 • Number of events 12 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 6 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Diarrhea (with colostomy)
|
10.0%
1/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Diarrhea (without colostomy)
|
70.0%
7/10 • Number of events 14 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Diarrhea (without colostomy) BMT
|
10.0%
1/10 • Number of events 4 • 9 years
|
0.00%
0/10 • 9 years
|
|
Nervous system disorders
Dizziness/lightheadedness
|
10.0%
1/10 • Number of events 1 • 9 years
|
20.0%
2/10 • Number of events 3 • 9 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
40.0%
4/10 • Number of events 5 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
General disorders
Edema
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
|
10.0%
1/10 • Number of events 2 • 9 years
|
10.0%
1/10 • Number of events 3 • 9 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
60.0%
6/10 • Number of events 10 • 9 years
|
40.0%
4/10 • Number of events 5 • 9 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
80.0%
8/10 • Number of events 22 • 9 years
|
10.0%
1/10 • Number of events 3 • 9 years
|
|
Vascular disorders
Flushing
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • 9 years
|
30.0%
3/10 • Number of events 4 • 9 years
|
|
Investigations
Hemoglobin (hgb)
|
100.0%
10/10 • Number of events 41 • 9 years
|
0.00%
0/10 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
30.0%
3/10 • Number of events 3 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
3/10 • Number of events 3 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
4/10 • Number of events 6 • 9 years
|
10.0%
1/10 • Number of events 2 • 9 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
40.0%
4/10 • Number of events 6 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10 • Number of events 2 • 9 years
|
20.0%
2/10 • Number of events 3 • 9 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
60.0%
6/10 • Number of events 6 • 9 years
|
20.0%
2/10 • Number of events 2 • 9 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
6/10 • Number of events 14 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
30.0%
3/10 • Number of events 5 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Vascular disorders
Hypotension
|
30.0%
3/10 • Number of events 3 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
5/10 • Number of events 9 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia
|
60.0%
6/10 • Number of events 9 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection w/out neutropenia, catheter related
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection without neutropenia
|
60.0%
6/10 • Number of events 15 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection without neutropenia, blood
|
10.0%
1/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection without neutropenia, C-diff
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection without neutropenia, Nasal Pharynx
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection without neutropenia, wound
|
10.0%
1/10 • Number of events 3 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection, Other (Upper respiratory infection (URI))
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Infections and infestations
Infection: blood
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
General disorders
Injection site reaction
|
80.0%
8/10 • Number of events 25 • 9 years
|
100.0%
10/10 • Number of events 29 • 9 years
|
|
General disorders
Injection site reaction, bilat arms
|
10.0%
1/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
General disorders
Injection site reaction, bilat legs
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Joint, muscle, or bone (osseous)- Other (Calf cramping)
|
10.0%
1/10 • Number of events 1 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Investigations
Leukocytes (total WBC)
|
80.0%
8/10 • Number of events 34 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Leukocytes (total WBC) for BMT
|
40.0%
4/10 • Number of events 9 • 9 years
|
0.00%
0/10 • 9 years
|
|
Blood and lymphatic system disorders
Lymphatics
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Blood and lymphatic system disorders
Lymphatics-Other (Adenopathy)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Lymphopenia
|
70.0%
7/10 • Number of events 29 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Metabolism and nutrition disorders
Metabolic-Other (Hyperbilirubinemia; hyperbilirubinemia r/t GVH)
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Psychiatric disorders
Mood alteration-depression
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Psychiatric disorders
Mood alteration-euphoria
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle ache)
|
10.0%
1/10 • Number of events 1 • 9 years
|
30.0%
3/10 • Number of events 7 • 9 years
|
|
Gastrointestinal disorders
Nausea
|
90.0%
9/10 • Number of events 25 • 9 years
|
0.00%
0/10 • 9 years
|
|
Nervous system disorders
Neuropathic pain
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Nervous system disorders
Neuropathy-sensory
|
50.0%
5/10 • Number of events 5 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
70.0%
7/10 • Number of events 19 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC) for BMT
|
40.0%
4/10 • Number of events 9 • 9 years
|
0.00%
0/10 • 9 years
|
|
Eye disorders
Ocular-Other (Ocular cGVHD)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
General disorders
Pain - Other
|
40.0%
4/10 • Number of events 8 • 9 years
|
20.0%
2/10 • Number of events 3 • 9 years
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Platelets
|
70.0%
7/10 • Number of events 22 • 9 years
|
30.0%
3/10 • Number of events 4 • 9 years
|
|
Investigations
Platelets for BMT
|
60.0%
6/10 • Number of events 11 • 9 years
|
0.00%
0/10 • 9 years
|
|
Psychiatric disorders
Pleural effusion (non-malignant)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Cardiac disorders
Pericardial effusion/pericarditis
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 2 • 9 years
|
30.0%
3/10 • Number of events 3 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other (URI)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
60.0%
6/10 • Number of events 11 • 9 years
|
20.0%
2/10 • Number of events 2 • 9 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation for BMT
|
20.0%
2/10 • Number of events 2 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
General disorders
Rigors/chills
|
20.0%
2/10 • Number of events 2 • 9 years
|
20.0%
2/10 • Number of events 4 • 9 years
|
|
Gastrointestinal disorders
Salivary gland changes
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
SGOT (AST)
|
80.0%
8/10 • Number of events 42 • 9 years
|
20.0%
2/10 • Number of events 2 • 9 years
|
|
Investigations
SGPT (ALT)
|
80.0%
8/10 • Number of events 32 • 9 years
|
30.0%
3/10 • Number of events 3 • 9 years
|
|
Skin and subcutaneous tissue disorders
Skin-Other (Drug reaction face, hands, neck)
|
10.0%
1/10 • Number of events 2 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
General disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
40.0%
4/10 • Number of events 5 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
20.0%
2/10 • Number of events 2 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Vascular disorders
Thrombosis/embolism
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Transfusion: Platelets for BMT
|
60.0%
6/10 • Number of events 6 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Transfusion: pRBCs
|
30.0%
3/10 • Number of events 4 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Transfusion: pRBCs for BMT
|
60.0%
6/10 • Number of events 6 • 9 years
|
0.00%
0/10 • 9 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
20.0%
2/10 • Number of events 4 • 9 years
|
0.00%
0/10 • 9 years
|
|
Nervous system disorders
Vasovagal episode
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
8/10 • Number of events 11 • 9 years
|
0.00%
0/10 • 9 years
|
|
Investigations
Weight loss
|
10.0%
1/10 • Number of events 1 • 9 years
|
0.00%
0/10 • 9 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
0.00%
0/10 • 9 years
|
20.0%
2/10 • Number of events 4 • 9 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Blood and lymphatic system disorders
Hematologic-Other (Splenomegaly in donor-resolved)
|
0.00%
0/10 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Vascular disorders
Hot flashes/flushes
|
0.00%
0/10 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
30.0%
3/10 • Number of events 4 • 9 years
|
0.00%
0/10 • 9 years
|
|
Gastrointestinal disorders
Diarrhea for BMT
|
30.0%
3/10 • Number of events 4 • 9 years
|
0.00%
0/10 • 9 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/10 • 9 years
|
10.0%
1/10 • Number of events 1 • 9 years
|
Additional Information
Dr, Claude Sportes, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-435-5280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place