Trial Outcomes & Findings for Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma (NCT NCT00004088)
NCT ID: NCT00004088
Last Updated: 2019-07-02
Results Overview
Response gradations are specified in the "Blade criteria", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
From enrollment in the study until day -8: before dilantin given pre-first high-dose chemo preceeding first cycle of tandem autologous cell transplant
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
High-dose Chemotherapy Followed by PBPC Rescue
Priming and Apheresis: Cyclophosphamide (CTX) 1.5 g/m2 and Filgrastim, 5 microgram/kg, t2x/day, until enough PBPC have been collected. This is day -10 to the first transplant.
Cycle (transplant) 1: day -1: Melphalan 150 mg/m2 IV; day 0: reinfusion of half of the collected stem cells; day +1: Filgrastim 5 micrograms/kg/day IV until ANC\>1000 per microliter.
Day 0 of cycle 2 (C2) is at least 12 weeks and not past 18 weeks from day 1 of cycle 1. Day -8 C2: Start Dilantin 1000 mg IV. Days -7 through -4 of C2: Busulfan 0.8 mg/kg every 6 hours, 4 x per day. Dilantin 300 micrograms/day. Day -3 C2: CTX 60 mg/kg; start IV Mesna. Day -2 C2: CTX 60 mg/kg; continue Mesna IV. Day 0 C2: Reinfuse PBPC. Start Filgrastim 5 microgram/kg daily.
12-18 weeks from day 0 of C2: alpha interferon 3 x 10 E 6 units/m2 3x per week (TIW) for 3 years.
At 6 months following day 0 of C2, Thalidomide 400 mg/m2 will be administered orally to patients not in Complete Remission.
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
High-dose Chemotherapy Followed by PBPC Rescue
Priming and Apheresis: Cyclophosphamide (CTX) 1.5 g/m2 and Filgrastim, 5 microgram/kg, t2x/day, until enough PBPC have been collected. This is day -10 to the first transplant.
Cycle (transplant) 1: day -1: Melphalan 150 mg/m2 IV; day 0: reinfusion of half of the collected stem cells; day +1: Filgrastim 5 micrograms/kg/day IV until ANC\>1000 per microliter.
Day 0 of cycle 2 (C2) is at least 12 weeks and not past 18 weeks from day 1 of cycle 1. Day -8 C2: Start Dilantin 1000 mg IV. Days -7 through -4 of C2: Busulfan 0.8 mg/kg every 6 hours, 4 x per day. Dilantin 300 micrograms/day. Day -3 C2: CTX 60 mg/kg; start IV Mesna. Day -2 C2: CTX 60 mg/kg; continue Mesna IV. Day 0 C2: Reinfuse PBPC. Start Filgrastim 5 microgram/kg daily.
12-18 weeks from day 0 of C2: alpha interferon 3 x 10 E 6 units/m2 3x per week (TIW) for 3 years.
At 6 months following day 0 of C2, Thalidomide 400 mg/m2 will be administered orally to patients not in Complete Remission.
|
|---|---|
|
Overall Study
No C2 given due to study on hold by IRB
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
HD Chemo Followed by PBPC Rescue
n=77 Participants
HD Melphalan/Cyclophosphamide followed by PBPC Rescue, alpha-interferon, \& pamidronate
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
|
Stage of Multiple Myeloma
Stage I (Low Tumor Mass)
|
6 Participants
n=5 Participants
|
|
Stage of Multiple Myeloma
Stage II (Intermediate Tumor Mass)
|
12 Participants
n=5 Participants
|
|
Stage of Multiple Myeloma
Stage III (High Tumor Mass)
|
50 Participants
n=5 Participants
|
|
Stage of Multiple Myeloma
unrecorded
|
9 Participants
n=5 Participants
|
|
M protein type
IgG
|
36 Participants
n=5 Participants
|
|
M protein type
IgA
|
22 Participants
n=5 Participants
|
|
M protein type
unrecorded
|
19 Participants
n=5 Participants
|
|
Prior Anthracycline Chemotherapy
No
|
6 Participants
n=5 Participants
|
|
Prior Anthracycline Chemotherapy
Yes
|
62 Participants
n=5 Participants
|
|
Prior Anthracycline Chemotherapy
not recorded
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment in the study until day -8: before dilantin given pre-first high-dose chemo preceeding first cycle of tandem autologous cell transplantResponse gradations are specified in the "Blade criteria", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.
Outcome measures
| Measure |
HD Chemo Followed by PBPC Rescue
n=68 Participants
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.
filgrastim
recombinant interferon alfa
busulfan
cyclophosphamide
melphalan
pamidronate disodium
thalidomide
peripheral blood stem cell transplantation
|
|---|---|
|
Best Response Prior to Tandem Autologous Stem Cell Transplant
CR
|
1 Participants
|
|
Best Response Prior to Tandem Autologous Stem Cell Transplant
VGPR
|
4 Participants
|
|
Best Response Prior to Tandem Autologous Stem Cell Transplant
PR/SD
|
62 Participants
|
|
Best Response Prior to Tandem Autologous Stem Cell Transplant
PD
|
1 Participants
|
PRIMARY outcome
Timeframe: After second cycle of tandem autologous stem cell transplant: Day 0 of second transplant to 12 weeks post-cycle 2 cell infusion of the tandem transplant.Response gradations are specified in the "Blade criteria", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.
Outcome measures
| Measure |
HD Chemo Followed by PBPC Rescue
n=65 Participants
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.
filgrastim
recombinant interferon alfa
busulfan
cyclophosphamide
melphalan
pamidronate disodium
thalidomide
peripheral blood stem cell transplantation
|
|---|---|
|
Response After Tandem Autologous Stem Cell Transplant
CR
|
27 Participants
|
|
Response After Tandem Autologous Stem Cell Transplant
VGPR
|
11 Participants
|
|
Response After Tandem Autologous Stem Cell Transplant
PR/SD
|
24 Participants
|
|
Response After Tandem Autologous Stem Cell Transplant
PD
|
3 Participants
|
PRIMARY outcome
Timeframe: Estimate reported at three years after day 0 of the first cycle of infusion of cells of the tandem transplant.Kaplan-Meier estimate at three years post-first transplant of survival. Outcome is death or alive at follow-up (censored). 95 percent confidence interval of the point estimate is calculated using Greenwood's variance.
Outcome measures
| Measure |
HD Chemo Followed by PBPC Rescue
n=68 Participants
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.
filgrastim
recombinant interferon alfa
busulfan
cyclophosphamide
melphalan
pamidronate disodium
thalidomide
peripheral blood stem cell transplantation
|
|---|---|
|
Three-year Overall Survival
|
0.662 proportion of participants
Interval 0.536 to 0.761
|
PRIMARY outcome
Timeframe: Estimate reported at three years after day 0 of the first cycle of infusion of cells of the tandem transplant.Kaplan-Meier estimate at three years post-first transplant of survival. Event of interest is the first of Death or Progression. Censoring is Alive in Continuous Complete Remission at date of last follow-up. 95 percent confidence interval of the point estimate is calculated using Greenwood's variance.
Outcome measures
| Measure |
HD Chemo Followed by PBPC Rescue
n=68 Participants
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.
filgrastim
recombinant interferon alfa
busulfan
cyclophosphamide
melphalan
pamidronate disodium
thalidomide
peripheral blood stem cell transplantation
|
|---|---|
|
Progression-free Survival
|
0.456 proportion of participants
Interval 0.335 to 0.539
|
PRIMARY outcome
Timeframe: Six months after day 0 of the first cycle of the tandem autologous stem cell transplant. This will be used to determine administration of thalidomide.Response gradations are specified in the "Blade criteria", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.
Outcome measures
| Measure |
HD Chemo Followed by PBPC Rescue
n=63 Participants
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.
filgrastim
recombinant interferon alfa
busulfan
cyclophosphamide
melphalan
pamidronate disodium
thalidomide
peripheral blood stem cell transplantation
|
|---|---|
|
Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant
CR
|
18 Participants
|
|
Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant
VGPR
|
5 Participants
|
|
Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant
PR/SD
|
29 Participants
|
|
Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant
PD
|
11 Participants
|
PRIMARY outcome
Timeframe: Response after six months after day 0 of the first cycle of the tandem transplant, after administration of maintenance thalidomide if necessary, until three years post-day 0 of the first cycle of the tandem transplant.Response gradations are specified in the "Blade criteria", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.
Outcome measures
| Measure |
HD Chemo Followed by PBPC Rescue
n=16 Participants
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.
filgrastim
recombinant interferon alfa
busulfan
cyclophosphamide
melphalan
pamidronate disodium
thalidomide
peripheral blood stem cell transplantation
|
|---|---|
|
Best Response After Tandem Autologous Stem Cell Transplant and Maintenance
CR
|
3 Participants
|
|
Best Response After Tandem Autologous Stem Cell Transplant and Maintenance
VGPR
|
1 Participants
|
|
Best Response After Tandem Autologous Stem Cell Transplant and Maintenance
PR/SD
|
6 Participants
|
|
Best Response After Tandem Autologous Stem Cell Transplant and Maintenance
PD
|
6 Participants
|
Adverse Events
HD Chemo Followed by PBPC Rescue
Serious events: 0 serious events
Other events: 68 other events
Deaths: 23 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HD Chemo Followed by PBPC Rescue
n=68 participants at risk
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.
filgrastim
recombinant interferon alfa
busulfan
cyclophosphamide
melphalan
pamidronate disodium
thalidomide
peripheral blood stem cell transplantation
|
|---|---|
|
Metabolism and nutrition disorders
Weight gain
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol.
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Weight loss
|
5.9%
4/68 • Number of events 5 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.3%
7/68 • Number of events 19 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
10.3%
7/68 • Number of events 15 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
10.3%
7/68 • Number of events 16 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
10.3%
7/68 • Number of events 20 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
8.8%
6/68 • Number of events 13 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
10.3%
7/68 • Number of events 20 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
10.3%
7/68 • Number of events 18 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.5%
1/68 • Number of events 3 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
|
10.3%
7/68 • Number of events 30 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
Platelets for BMT studies, if specified in the protocol.
|
10.3%
7/68 • Number of events 24 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets for BMT studies, if specified in the protocol.
|
10.3%
7/68 • Number of events 11 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs for BMT studies, if specified in the protocol.
|
8.8%
6/68 • Number of events 9 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
1.5%
1/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Cardiac disorders
Palpitations
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
2.9%
2/68 • Number of events 3 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Cardiac disorders
Vasovagal episode
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Cardiac disorders
Hypertension
|
7.4%
5/68 • Number of events 7 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Cardiac disorders
Hypotension
|
2.9%
2/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __) AUDITORY/EAR CONGESTION
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Endocrine disorders
Hot flashes/flushes
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Eye disorders
Vision-blurred vision
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
4/68 • Number of events 5 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Dehydration
|
4.4%
3/68 • Number of events 4 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
2/68 • Number of events 4 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Diarrhea associated with graft versus host disease (GVHD)
|
4.4%
3/68 • Number of events 5 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.9%
4/68 • Number of events 7 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Esophagitis
|
5.9%
4/68 • Number of events 5 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) BENIGN PAPILLOMA
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) DECREASED GASTRIC MOTILITY
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) INCREASED SALIVA PRODUCTION
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __) TONGUE DISCOLORATION
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
4.4%
3/68 • Number of events 4 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
7/68 • Number of events 17 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Proctitis
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.
|
10.3%
7/68 • Number of events 15 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
4.4%
3/68 • Number of events 6 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
7/68 • Number of events 11 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
10.3%
7/68 • Number of events 19 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
8.8%
6/68 • Number of events 7 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Insomnia
|
7.4%
5/68 • Number of events 8 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Rigors/chills
|
2.9%
2/68 • Number of events 3 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain
|
10.3%
7/68 • Number of events 35 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) ARM PAIN
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) BACK PAIN
|
2.9%
2/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) BURNING SENSATION AROUND MOUTH
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) BURNING SENSATION IN MOUTH
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) JAW PAIN
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) LOW BACK PAIN
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) PAIN AT CATHETER SITE
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) SEVERE MOUTH PAIN
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
General disorders
Pain - Other (Specify, __) TOOTHACHE
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __) LOW ALKALINE PHOSPHATASE
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.4%
3/68 • Number of events 4 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Immune system disorders
Graft versus host disease
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Infections and infestations
Febrile neutropenia (fever without clinically or microbiologically documented infection)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Infections and infestations
Infection without neutropenia
|
2.9%
2/68 • Number of events 4 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Infections and infestations
Infection, Viral
|
2.9%
2/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
10.3%
7/68 • Number of events 19 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
8.8%
6/68 • Number of events 12 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Creatinine
|
2.9%
2/68 • Number of events 4 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.3%
7/68 • Number of events 11 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
4.4%
3/68 • Number of events 3 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
7.4%
5/68 • Number of events 7 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
10.3%
7/68 • Number of events 11 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.3%
7/68 • Number of events 12 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.9%
4/68 • Number of events 6 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
4.4%
3/68 • Number of events 5 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Cognitive disturbance
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Confusion
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Dizziness
|
7.4%
5/68 • Number of events 6 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Neuropathy: sensory
|
4.4%
3/68 • Number of events 4 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Tremor
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Nervous system disorders
Vertigo
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Psychiatric disorders
Mood alteration
|
8.8%
6/68 • Number of events 15 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.9%
2/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
5/68 • Number of events 9 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.4%
5/68 • Number of events 5 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.9%
2/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) DERMATOLOGY, SKIN OTHER (CHELIOSIS)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __) DERMATOLOGY/ SI. ERYTHEMA AROUND HICKMAN
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
2/68 • Number of events 3 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
2.9%
2/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
2.9%
2/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.8%
6/68 • Number of events 9 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation associated with graft versus host disease (GVHD)
|
8.8%
6/68 • Number of events 11 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Vascular disorders
Edema
|
7.4%
5/68 • Number of events 6 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Vascular disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
1.5%
1/68 • Number of events 2 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.5%
1/68 • Number of events 1 • From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.
|
Additional Information
Brenda Williams, Senior Director, Clinical Trials Office
City of Hope
Phone: 626-218-2702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place