Trial Outcomes & Findings for A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma (NCT NCT03003520)
NCT ID: NCT03003520
Last Updated: 2023-05-22
Results Overview
The primary efficacy analysis evaluated the complete response rate (CRR) at the end of the induction therapy in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined as a complete metabolic response and radiographic evidence showing target nodes/nodal masses regressed to ≤ 1.5 cm in longest diameter, no new lesions, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis for the primary endpoint was rejected if the lower limit of the confidence interval for the complete response rate at the completion of the induction therapy in the efficacy evaluable population is above 55%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
Results posted on
2023-05-22
Participant Flow
Participant milestones
| Measure |
DUR + R-CHOP
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
3
|
|
Overall Study
Completed Induction Treatment
|
31
|
3
|
|
Overall Study
Completed Consolidation Treatment
|
14
|
2
|
|
Overall Study
COMPLETED
|
14
|
2
|
|
Overall Study
NOT COMPLETED
|
29
|
1
|
Reasons for withdrawal
| Measure |
DUR + R-CHOP
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other reasons
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Progressive disease
|
9
|
1
|
Baseline Characteristics
A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
DUR + R-CHOP
n=43 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=3 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 8.62 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
|
Age, Customized
<65 years
|
23 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
20 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Colected or Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
0 = Fully Active
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
1 = Restricted activity but ambulatory
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
2 = Ambulatory but unable to work
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
3 = Limited Self-Care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
4 = Completely Disabled, No self-care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ann Arbor Stage at Diagnosis
Stage I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ann Arbor Stage at Diagnosis
Stage II
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ann Arbor Stage at Diagnosis
Stage III
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ann Arbor Stage at Diagnosis
Stage IV
|
34 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Presence of Bulky Disease at Baseline
Yes
|
21 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Presence of Bulky Disease at Baseline
No
|
22 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
International Prognostic Index (IPSS) Score
0-1: Low risk
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
International Prognostic Index (IPSS) Score
2: Low-Intermediate risk
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
International Prognostic Index (IPSS) Score
3: High-Intermediate risk
|
21 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
International Prognostic Index (IPSS) Score
4-5: High risk
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
International Prognostic Index (IPSS) Score
Missing
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).Population: Efficacy Evaluable Population includes participants who completed at least one cycle of their assigned treatment, had a baseline assessment by CT scan and at least one post baseline tumor response assessment.
The primary efficacy analysis evaluated the complete response rate (CRR) at the end of the induction therapy in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined as a complete metabolic response and radiographic evidence showing target nodes/nodal masses regressed to ≤ 1.5 cm in longest diameter, no new lesions, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis for the primary endpoint was rejected if the lower limit of the confidence interval for the complete response rate at the completion of the induction therapy in the efficacy evaluable population is above 55%.
Outcome measures
| Measure |
DUR + R-CHOP
n=37 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=3 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy
|
54.1 percentage of participants
Interval 36.9 to 70.5
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: From first dose of study drug to completion of at least one cycle in the Consolidation Period (Day 1 up to Week 52)Population: Efficacy Evaluable Population includes participants who completed at least one cycle of their assigned treatment, had a baseline assessment by CT scan and at least one post baseline tumor response assessment.
The percentage of participants who achieved a partial response (PR) or complete response (CR) at the end of Induction and continued into consolidation period in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined in outcome #1. PR was defined as a partial metabolic response and radiographic evidence showing ≥ 50% decrease in sum of perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length beyond normal, and residual bone marrow involvement improved from baseline. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis was rejected if the lower limit of the confidence interval for the rate of subjects who continue consolidation therapy out of all subjects.
Outcome measures
| Measure |
DUR + R-CHOP
n=37 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=3 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018)
|
67.6 percentage of participants
Interval 50.2 to 82.0
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).Population: The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm\^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.
Outcome measures
| Measure |
DUR + R-CHOP
n=15 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=11 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density
|
67 percentage of participants
|
64 percentage of participants
|
SECONDARY outcome
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).Population: The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm\^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.
Outcome measures
| Measure |
DUR + R-CHOP
n=20 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=5 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage
|
75 percentage of participants
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).Population: The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm\^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.
Outcome measures
| Measure |
DUR + R-CHOP
n=11 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=9 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells
|
64 percentage of participants
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).Population: The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm\^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.
Outcome measures
| Measure |
DUR + R-CHOP
n=7 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=20 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data
|
43 percentage of participants
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. (Up to approximately 72 weeks)Population: Safety Population, which consists of all participants who received at least 1 dose of the study medications. Participants were analyzed in the arm of the actual treatment received.
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator.
Outcome measures
| Measure |
DUR + R-CHOP
n=43 Participants
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=3 Participants
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>= 1 Treatment-emergent adverse event (TEAE)
|
43 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE related to durvalumab
|
33 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE related to R-CHOP
|
40 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE related to lenalidomide
|
—
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE related to durvalumab or any other IP
|
41 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE severity grade 3-4
|
37 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE severity grade 3-4 related to durvalumab
|
18 Participants
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE severity grade 3-4 related to R-CHOP
|
27 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE severity grade 3-4 related to lenalidomid
|
—
|
2 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE severity grade 3-4 related to any IP
|
31 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE severity grade 5
|
3 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 TEAE severity grade 5 related to any IP
|
0 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 serious TEAE
|
23 Participants
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 serious TEAE related to durvalumab
|
10 Participants
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 serious TEAE related to R-CHOP
|
10 Participants
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 serious TEAE related to lenalidomide
|
—
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 serious TEAE related to any IP
|
14 Participants
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to discontinuation of durvalumab
|
13 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to discontinuation of R-CHOP
|
4 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to discontinuation of lenalidomide
|
—
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to discontinuation of any IP
|
13 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to interruption of durvalumab
|
15 Participants
|
2 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to interruption of R-CHOP
|
12 Participants
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to interruption of lenalidomide
|
—
|
2 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to interruption of any IP
|
18 Participants
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to infusion interruption of durvalumab
|
2 Participants
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to dose reduction of vincristine
|
4 Participants
|
1 Participants
|
|
Participants With Treatment Emergent Adverse Events (TEAE)
>=1 leading to dose reduction of lenalidomide
|
—
|
1 Participants
|
Adverse Events
DUR + R-CHOP
Serious events: 23 serious events
Other events: 43 other events
Deaths: 5 deaths
DUR + R2-CHOP
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DUR + R-CHOP
n=43 participants at risk
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=3 participants at risk
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.0%
6/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
Fatigue
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
General physical health deterioration
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
Pyrexia
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Device related infection
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Infection
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Influenza
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Lung infection
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Meningitis bacterial
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Perirectal abscess
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Pneumonia
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Viral diarrhoea
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma recurrent
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Vascular disorders
Venous thrombosis
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
Other adverse events
| Measure |
DUR + R-CHOP
n=43 participants at risk
Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5).
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
DUR + R2-CHOP
n=3 participants at risk
Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1.
Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.3%
7/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.3%
7/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
48.8%
21/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
100.0%
3/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Eye disorders
Vision blurred
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.6%
5/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Constipation
|
20.9%
9/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
66.7%
2/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.2%
13/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
18.6%
8/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Nausea
|
41.9%
18/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
66.7%
2/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
18.6%
8/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
66.7%
2/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
10/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
Chills
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
Fatigue
|
60.5%
26/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
66.7%
2/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
Mucosal inflammation
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
Oedema peripheral
|
14.0%
6/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
General disorders
Pyrexia
|
20.9%
9/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Influenza
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Lung infection
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Oral candidiasis
|
11.6%
5/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Oral herpes
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.6%
5/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Investigations
Weight decreased
|
16.3%
7/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.9%
12/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.6%
8/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.3%
7/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.3%
7/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytic necrotising lymphadenitis
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Dizziness
|
20.9%
9/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Dysgeusia
|
14.0%
6/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Headache
|
25.6%
11/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
53.5%
23/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
66.7%
2/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Nervous system disorders
Taste disorder
|
9.3%
4/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Psychiatric disorders
Depression
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Psychiatric disorders
Insomnia
|
25.6%
11/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Renal and urinary disorders
Dysuria
|
4.7%
2/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.9%
9/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.3%
10/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.0%
6/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.3%
10/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.3%
1/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.6%
5/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.6%
8/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
33.3%
1/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Vascular disorders
Hot flush
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
|
Vascular disorders
Hypotension
|
7.0%
3/43 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
|
0.00%
0/3 • AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
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Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER