Trial Outcomes & Findings for Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702) (NCT NCT01109004)
NCT ID: NCT01109004
Last Updated: 2021-12-09
Results Overview
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 of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
758 participants
Primary outcome timeframe
38 months post-randomization
Results posted on
2021-12-09
Participant Flow
Participant milestones
| Measure |
Tandem Auto Transplant
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
Overall Study
STARTED
|
247
|
254
|
257
|
|
Overall Study
COMPLETED
|
247
|
254
|
257
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
Baseline characteristics by cohort
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Total
n=758 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
57 years
n=7 Participants
|
56 years
n=5 Participants
|
56 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
454 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
178 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
571 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
50 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple/Other/Unknown
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Karnofsky Performance Score (KPS)
90 or Greater
|
182 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
523 Participants
n=4 Participants
|
|
Karnofsky Performance Score (KPS)
Less Than 90
|
65 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Disease Risk
Standard
|
175 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
535 Participants
n=4 Participants
|
|
Disease Risk
High
|
72 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
223 Participants
n=4 Participants
|
|
Initial Therapy
Bortezomib/Lenalidomide/Dexamethasone
|
141 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
420 Participants
n=4 Participants
|
|
Initial Therapy
Bortezomib/Cyclophosphamide/Dexamethasone
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Initial Therapy
Lenalidomide/Dexamethasone
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Initial Therapy
Bortezomib/Dexamethasone
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Initial Therapy
Other
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Initial Therapy
Unknown
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Time from Initial Therapy to Enrollment
|
5 months
n=5 Participants
|
5 months
n=7 Participants
|
5 months
n=5 Participants
|
5 months
n=4 Participants
|
|
Number of Lines of Therapy
1
|
210 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
641 Participants
n=4 Participants
|
|
Number of Lines of Therapy
2
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Number of Lines of Therapy
3
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Number of Lines of Therapy
Unknown
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Stringent Complete Response
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Complete Response
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Near Complete Response
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Very Good Partial Response
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Partial Response
|
106 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
337 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Stable Disease
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Progression
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Disease Status at Enrollment
Not Evaluable
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 38 months post-randomizationProgression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
Percentage of Participants With Progression-free Survival (PFS)
|
58.5 percentage of participants
Interval 51.7 to 64.6
|
57.8 percentage of participants
Interval 51.4 to 63.7
|
53.9 percentage of participants
Interval 47.4 to 60.0
|
SECONDARY outcome
Timeframe: 38 months post-randomizationDisease Progression is defined as progression of multiple myeloma, including one or more of the following: * A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL * 24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours * Abnormal free light chain levels of \>10 mg/dl, only in patients without measurable paraprotein in the serum and urine * At least 10% plasma cells in a bone marrow aspirate or on 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 any other cause To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
Percentage of Participants With Disease Progression
|
39.8 percentage of participants
Interval 33.4 to 46.1
|
41.0 percentage of participants
Interval 34.7 to 47.0
|
45.6 percentage of participants
Interval 39.2 to 51.8
|
SECONDARY outcome
Timeframe: 38 months post-randomizationOverall survival is defined as survival of death from any cause. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate overall survival at 38 months post-randomization.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
Percentage of Participants With Overall Survival (OS)
|
81.8 percentage of participants
Interval 76.2 to 86.2
|
85.4 percentage of participants
Interval 80.4 to 89.3
|
83.7 percentage of participants
Interval 78.4 to 87.8
|
SECONDARY outcome
Timeframe: Up to 38 months post-randomizationTRM is defined as death prior to progression of multiple myeloma. To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating disease progression as a competing risk.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-related Mortality (TRM)
|
1.7 percentage of participants
Interval 0.6 to 4.2
|
1.2 percentage of participants
Interval 0.3 to 3.3
|
0.5 percentage of participants
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: 1 and 2 years post-randomizationPopulation: Only participants that were evaluable for disease response were analyzed at each time point. Those who had died or experienced disease progression were excluded.
The number of participants with very good partial response (VGPR) or better \[complete response (CR), near CR (nCR), and stringent CR (sCR)\] according to the International Uniform Response Criteria will be calculated. The "Worse than VGPR" group includes PR, stable disease, and progressive disease. sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: \< 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR \>=90% reduction in serum PPN plus urine PPN \<100 mg/24hrs, \>= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either \>= 90% or to \<200 mg/24 hours in light chain disease, \>= 50% reduction in the size of soft tissue plasmacytomas
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
Number of Participants With Treatment Response
2 Years · VGPR or nCR
|
39 Participants
|
37 Participants
|
41 Participants
|
|
Number of Participants With Treatment Response
1 Year · CR or sCR
|
97 Participants
|
122 Participants
|
98 Participants
|
|
Number of Participants With Treatment Response
1 Year · VGPR or nCR
|
56 Participants
|
50 Participants
|
60 Participants
|
|
Number of Participants With Treatment Response
1 Year · Worse than VGPR
|
39 Participants
|
37 Participants
|
50 Participants
|
|
Number of Participants With Treatment Response
2 Years · CR or sCR
|
98 Participants
|
117 Participants
|
93 Participants
|
|
Number of Participants With Treatment Response
2 Years · Worse than VGPR
|
20 Participants
|
21 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years post-randomizationPopulation: Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.
The Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life instrument that assesses the effects of cancer therapy on a patient's physical, social/family, emotional, and functional well-being. The assessment has 27 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-108, with higher scores indicating higher levels of overall well-being.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
FACT-G Total Score
Baseline
|
79 score on a scale
Standard Error 1.0
|
79 score on a scale
Standard Error 1.0
|
77 score on a scale
Standard Error 1.0
|
|
FACT-G Total Score
1 Year
|
84 score on a scale
Standard Error 1.3
|
84 score on a scale
Standard Error 1.3
|
83 score on a scale
Standard Error 1.2
|
|
FACT-G Total Score
2 Years
|
84 score on a scale
Standard Error 1.5
|
84 score on a scale
Standard Error 1.3
|
85 score on a scale
Standard Error 1.4
|
|
FACT-G Total Score
3 Years
|
85 score on a scale
Standard Error 1.6
|
84 score on a scale
Standard Error 1.6
|
85 score on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Up to 3 years post-randomizationPopulation: Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.
The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
FACT-BMT Score
Baseline
|
107 score on a scale
Standard Error 1.4
|
107 score on a scale
Standard Error 1.3
|
105 score on a scale
Standard Error 1.3
|
|
FACT-BMT Score
1 Year
|
113 score on a scale
Standard Error 1.7
|
115 score on a scale
Standard Error 1.7
|
113 score on a scale
Standard Error 1.6
|
|
FACT-BMT Score
2 Years
|
114 score on a scale
Standard Error 1.8
|
115 score on a scale
Standard Error 1.7
|
115 score on a scale
Standard Error 1.7
|
|
FACT-BMT Score
3 Years
|
115 score on a scale
Standard Error 2.0
|
114 score on a scale
Standard Error 2.1
|
115 score on a scale
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Up to 3 years post-randomizationPopulation: Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.
The Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index is a quality of life instrument that assesses the impact of bone marrow transplantation (BMT) on a patient's physical and functional well-being while taking into consideration BMT-specific concerns. The assessment has 24 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-96, with higher scores indicating higher levels of overall well-being.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
FACT-BMT Trial Outcome Index
3 Years
|
73 score on a scale
Standard Error 1.4
|
71 score on a scale
Standard Error 1.5
|
73 score on a scale
Standard Error 1.5
|
|
FACT-BMT Trial Outcome Index
Baseline
|
64 score on a scale
Standard Error 1.1
|
65 score on a scale
Standard Error 1.0
|
63 score on a scale
Standard Error 1.0
|
|
FACT-BMT Trial Outcome Index
1 Year
|
70 score on a scale
Standard Error 1.2
|
72 score on a scale
Standard Error 1.2
|
71 score on a scale
Standard Error 1.1
|
|
FACT-BMT Trial Outcome Index
2 Years
|
73 score on a scale
Standard Error 1.2
|
73 score on a scale
Standard Error 1.3
|
73 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Up to 3 years post-randomizationPopulation: Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.
The Medical Outcome Study (MOS) SF-36 Physical Component Summary is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
MOS SF-36 Physical Component Summary
Baseline
|
37 score on a scale
Standard Deviation 0.7
|
39 score on a scale
Standard Deviation 0.7
|
38 score on a scale
Standard Deviation 0.7
|
|
MOS SF-36 Physical Component Summary
1 Year
|
43 score on a scale
Standard Deviation 0.8
|
43 score on a scale
Standard Deviation 0.8
|
42 score on a scale
Standard Deviation 0.7
|
|
MOS SF-36 Physical Component Summary
2 Years
|
44 score on a scale
Standard Deviation 0.8
|
44 score on a scale
Standard Deviation 0.9
|
43 score on a scale
Standard Deviation 0.9
|
|
MOS SF-36 Physical Component Summary
3 Years
|
42 score on a scale
Standard Deviation 1.0
|
42 score on a scale
Standard Deviation 1.0
|
43 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Up to 3 years post-randomizationPopulation: Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.
The Medical Outcome Study (MOS) SF-36 Mental Component Summary is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.
Outcome measures
| Measure |
Tandem Auto Transplant
n=247 Participants
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 Participants
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 Participants
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
MOS SF-36 Mental Component Summary
Baseline
|
49 score on a scale
Standard Deviation 0.7
|
48 score on a scale
Standard Deviation 0.7
|
48 score on a scale
Standard Deviation 0.8
|
|
MOS SF-36 Mental Component Summary
1 Year
|
50 score on a scale
Standard Deviation 0.9
|
51 score on a scale
Standard Deviation 0.8
|
50 score on a scale
Standard Deviation 0.8
|
|
MOS SF-36 Mental Component Summary
2 Years
|
50 score on a scale
Standard Deviation 1.0
|
50 score on a scale
Standard Deviation 0.8
|
50 score on a scale
Standard Deviation 1.0
|
|
MOS SF-36 Mental Component Summary
3 Years
|
51 score on a scale
Standard Deviation 1.0
|
50 score on a scale
Standard Deviation 1.1
|
51 score on a scale
Standard Deviation 1.0
|
Adverse Events
Tandem Auto Transplant
Serious events: 42 serious events
Other events: 0 other events
Deaths: 0 deaths
RVD Consolidation
Serious events: 45 serious events
Other events: 0 other events
Deaths: 0 deaths
Lenalidomide Maintenance
Serious events: 53 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tandem Auto Transplant
n=247 participants at risk
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
RVD Consolidation
n=254 participants at risk
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
Lenalidomide Maintenance
n=257 participants at risk
Initial autologous transplant followed by lenalidomide maintenance
Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Cardiac disorders
Cardiac failure congestive
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Cardiac disorders
Cardiac valve disease
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.81%
2/247 • Number of events 2
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.40%
1/247 • Number of events 1
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Eye disorders
Cataract
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/247
|
0.79%
2/254 • Number of events 2
|
0.00%
0/257
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/247
|
0.00%
0/254
|
0.78%
2/257 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/247
|
0.00%
0/254
|
0.78%
2/257 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.81%
2/247 • Number of events 2
|
0.39%
1/254 • Number of events 1
|
1.6%
4/257 • Number of events 4
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Hepatobiliary disorders
Cholecystitis
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
1.2%
3/257 • Number of events 3
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Infections and infestations
Appendicitis
|
0.00%
0/247
|
0.00%
0/254
|
0.78%
2/257 • Number of events 2
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.78%
2/257 • Number of events 2
|
|
Investigations
Arthroscopy
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/247
|
1.2%
3/254 • Number of events 3
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/247
|
0.00%
0/254
|
0.78%
2/257 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.81%
2/247 • Number of events 2
|
1.2%
3/254 • Number of events 3
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Nervous system disorders
Neuropathy peripheral
|
0.40%
1/247 • Number of events 1
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Nervous system disorders
Spinal cord compression
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Nervous system disorders
Syncope
|
0.40%
1/247 • Number of events 1
|
1.2%
3/254 • Number of events 3
|
0.00%
0/257
|
|
Psychiatric disorders
Mania
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.81%
2/247 • Number of events 2
|
0.00%
0/254
|
0.78%
2/257 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
4/247 • Number of events 4
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
1.6%
4/257 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Surgical and medical procedures
Cataract operation
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/247
|
0.00%
0/254
|
0.39%
1/257 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.81%
2/247 • Number of events 2
|
0.39%
1/254 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.40%
1/247 • Number of events 1
|
0.00%
0/254
|
0.00%
0/257
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/247
|
0.39%
1/254 • Number of events 1
|
0.00%
0/257
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place