Trial Outcomes & Findings for Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT) (NCT NCT02322320)
NCT ID: NCT02322320
Last Updated: 2020-05-11
Results Overview
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
273 participants
Primary outcome timeframe
5 years post-randomization in BMT CTN 0702
Results posted on
2020-05-11
Participant Flow
Participant milestones
| Measure |
Tandem Auto Transplant
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
86
|
89
|
|
Overall Study
COMPLETED
|
98
|
86
|
89
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
Baseline characteristics by cohort
| Measure |
Tandem Auto Transplant
n=98 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
n=86 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
n=89 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
56 years
n=7 Participants
|
57 years
n=5 Participants
|
56 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
22 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
205 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Karnofsky Performance Score (KPS)
90-100
|
78 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Karnofsky Performance Score (KPS)
70-80
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Diseae Risk at BMT CTN 0702 Enrollment
Standard
|
73 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Diseae Risk at BMT CTN 0702 Enrollment
High
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 years post-randomization in BMT CTN 0702Population: All 754 randomized BMT CTN 0702 participants are included in this analysis
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
|---|---|---|---|
|
Percentage of Participants With Progression-free Survival (PFS)
|
47.7 percentage of participants
Interval 41.1 to 53.8
|
44.1 percentage of participants
Interval 38.0 to 50.3
|
45.0 percentage of participants
Interval 38.8 to 51.2
|
SECONDARY outcome
Timeframe: 5 years post-randomization in BMT CTN 0702Population: All 754 randomized BMT CTN 0702 participants are included in this analysis
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
|---|---|---|---|
|
Percentage of Participants With Overall Survival (OS)
|
74.7 percentage of participants
Interval 69.1 to 80.0
|
75.4 percentage of participants
Interval 70.0 to 80.6
|
76.4 percentage of participants
Interval 71.0 to 81.5
|
SECONDARY outcome
Timeframe: 5 years post-randomization in BMT CTN 0702Population: All 754 randomized BMT CTN 0702 participants are included in this analysis
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Event-free survival is defined as survival without disease progression, second primary malignancy, and death. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate event-free survival during the 5 year post-randomization follow-up period.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
|---|---|---|---|
|
Percentage of Participants With Event-free Survival (EFS)
|
44.2 percentage of participants
Interval 38.0 to 50.5
|
42.1 percentage of participants
Interval 36.1 to 48.3
|
42.4 percentage of participants
Interval 36.4 to 48.6
|
SECONDARY outcome
Timeframe: 5 years post-randomization in BMT CTN 0702Population: All 754 randomized BMT CTN 0702 participants are included in this analysis
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
|---|---|---|---|
|
Percentage of Participants With Secondary Primary Malignancies (SPM)
|
10.8 percentage of participants
Interval 7.2 to 15.1
|
7.9 percentage of participants
Interval 4.9 to 11.6
|
7.2 percentage of participants
Interval 4.3 to 10.8
|
SECONDARY outcome
Timeframe: 5 years post-randomization in BMT CTN 0702Population: All 754 randomized BMT CTN 0702 participants are included in this analysis
This analysis includes all randomized subjects from BMT CTN 0702, classified by their treatment assignment (intention-to-treat). Disease progression is defined as progression of multiple myeloma, including one or more of the following: * Reappearance of serum monoclonal paraprotein at a level \>= 0.5 g/dL * 24-hour urine protein electrophoresis of at least 200mg paraprotein/24 hours * Abnormal free light chain levels of \>10 mg/dl, only in patients without measurable paraprotein in serum and urine * At least 10% plasma cells in a bone marrow aspirate or trephine biopsy * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of new bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum Ca \>11.5 mg/dL or \>2.8 mmol/L) not attributable to other causes To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of progression during the follow-up period.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
|---|---|---|---|
|
Percentage of Participants With Disease Progression
|
48.8 percentage of participants
Interval 42.5 to 55.2
|
54.3 percentage of participants
Interval 48.1 to 60.4
|
54.2 percentage of participants
Interval 48.0 to 60.4
|
Adverse Events
Tandem Auto Transplant
Serious events: 6 serious events
Other events: 0 other events
Deaths: 4 deaths
RVD Consolidation
Serious events: 10 serious events
Other events: 0 other events
Deaths: 4 deaths
Lenalidomide Maintenance
Serious events: 6 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Tandem Auto Transplant
n=98 participants at risk
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
RVD Consolidation
n=86 participants at risk
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
Lenalidomide Maintenance
n=89 participants at risk
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.0%
1/98 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 2 • 22 months post-enrollment to BMT CTN 07LT
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
|
Investigations
Liver function test increased
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
1.0%
1/98 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B precursor type acute leukaemia
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell type acute leukaemia
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
1.0%
1/98 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.0%
1/98 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
1.0%
1/98 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Nervous system disorders
Dizziness
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Nervous system disorders
Syncope
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
1.2%
1/86 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/98 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
1.1%
1/89 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/98 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
|
Vascular disorders
Hypotension
|
1.0%
1/98 • Number of events 1 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/86 • 22 months post-enrollment to BMT CTN 07LT
|
0.00%
0/89 • 22 months post-enrollment to BMT CTN 07LT
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place