Trial Outcomes & Findings for Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma (NCT NCT02911142)

Last Updated: 2025-07-28

Results Overview

The MTD is the dose level at which no more than 1 of up to 6 participants experiences dose-limiting toxicity (DLT) during the first two cycles of DA-EPOCH-R2 treatment. Association of treatment regimen with one-year overall survival. DLT is defined as any grade 4 adverse event at least possibly related to lenalidomide and not probably or definitely related to human immunodeficiency virus (HIV) or a Kaposi sarcoma-associated herpesvirus KSHV-associated malignancy resulting in a dose delay in etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) treatment \>2 weeks due to failure to resolve to grade 3 or lower. Any grade 3 cardiac toxicity that is at least possibly related to lenalidomide and not probably or definitely related to HIV or a Kaposi sarcoma-associated herpesvirus (KSHV)-associated malignancy resulting in a dose delay in DA-EPOCH-R treatment \>2 weeks due to failure to resolve to grade 2 or lower.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

First 6 weeks of treatment (2 cycles of treatment)

Results posted on

2025-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Phase I - Safety & Tolerability STARTED	6
Phase I - Safety & Tolerability Received Specified Dose	6
Phase I - Safety & Tolerability Underwent Screening/Staging	6
Phase I - Safety & Tolerability Evaluated for Response	6
Phase I - Safety & Tolerability Off Treatment	6
Phase I - Safety & Tolerability Off Study	6
Phase I - Safety & Tolerability Disease Progression on Study	1
Phase I - Safety & Tolerability COMPLETED	5
Phase I - Safety & Tolerability NOT COMPLETED	1
Phase II - Recommended Phase 2 Dose STARTED	11
Phase II - Recommended Phase 2 Dose Received Specified Dose	11
Phase II - Recommended Phase 2 Dose Evaluated for Response	11
Phase II - Recommended Phase 2 Dose Off Treatment	11
Phase II - Recommended Phase 2 Dose Off Study	11
Phase II - Recommended Phase 2 Dose Disease Progression on Study	3
Phase II - Recommended Phase 2 Dose COMPLETED	7
Phase II - Recommended Phase 2 Dose NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Phase I - Safety & Tolerability Did not complete last cycle of EPOCH-R2 due to progressive disease.	1
Phase II - Recommended Phase 2 Dose Refused further treatment	1
Phase II - Recommended Phase 2 Dose Physician Decision	2
Phase II - Recommended Phase 2 Dose Death	1

Baseline Characteristics

Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	40.53 years STANDARD_DEVIATION 13.53 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: First 6 weeks of treatment (2 cycles of treatment)

Population: 6/17 participants were analyzed because MTD was only assessed during phase I which was only 6 participants.

Outcome measures

Outcome measures
Measure	All Participants n=6 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
(Phase I) Maximum Tolerated Dose (MTD) of Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2)	25 mg/day

PRIMARY outcome

Timeframe: End of follow up period (5 years)

Median amount of time subject survives post therapy

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
(Phase II) Overall Survival in Treatment-naive Participants With Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 90% Confidence Interval	NA years Interval 0.4 to Median survival was not calculable because at the end of the follow-up period, more than 50% of the participants were still alive.

PRIMARY outcome

Timeframe: End of follow up period (5 years)

Median amount of time subject survives post therapy.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
(Phase II) Overall Survival in Treatment-naive Participants With Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 95% Confidence Interval	NA years Interval 0.36 to Median survival was not calculable because at the end of the follow-up period, more than 50% of the participants were still alive.

SECONDARY outcome

Timeframe: Response rate was calculated at the end of treatment (18 weeks of treatment)

Response rate is defined as the percentage of participants who have either a complete response (CR) or partial response (PR) for primary effusion lymphoma treated with etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R2) measured by the International Working Group Response Criteria for Malignant Lymphomas. Complete response (CR) is complete disappearance of all detectable evidence of disease. Partial response (PR) is at least a ≥50% decrease in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Response Rate for Primary Effusion Lymphoma Reported Using a 90% Confidence Interval	76 percentage of participants Interval 54.0 to 92.0

SECONDARY outcome

Timeframe: Response rate was calculated at the end of treatment (after 18 weeks of treatment)

Response rate is defined as the percentage of participants who have either a Complete Response (CR) or Partial Response (PR) for primary effusion lymphoma treated with etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R2) measured by the International Working Group Response Criteria for Malignant Lymphomas. Complete response (CR) is complete disappearance of all detectable evidence of disease. Partial response (PR) is at least a ≥50% decrease in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Response Rate for Primary Effusion Lymphoma Reported Using a 95% Confidence Interval	76 percentage of participants Interval 50.0 to 93.0

SECONDARY outcome

Timeframe: Over follow-up period, a median of 26 months

PFS is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma or death, whichever occurs first, measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules).

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Progression-free Survival (PFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Using a 90% Confidence Interval	0.72 years Interval 0.37 to Upper end of the confidence interval of the Kaplan-Meier survival curve was not calculable because the proportion of participants who had progressive disease was too small.

SECONDARY outcome

Timeframe: Over a follow-up period, a median of 26 months

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Progression-free Survival (PFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Using a 95% Confidence Interval	0.72 years Interval 0.31 to Upper end of the confidence interval of the Kaplan-Meier survival curve was not calculable because the proportion of participants who had progressive disease was too small.

SECONDARY outcome

Timeframe: Over a follow-up period, a median of 26 months

Event-Free Survival (EFS) is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma. Progressive disease was measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is the appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules).

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Event-free Survival (EFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 90% Confidence Interval	0.72 years Interval 0.37 to Upper end of the confidence interval of the Kaplan-Meier survival curve was not calculable because the proportion of participants who had progressive disease was too small.

SECONDARY outcome

Timeframe: Over a follow-up period, a median of 26 months

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Event-free Survival (EFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 95% Confidence Interval	0.72 Months Interval 0.31 to Upper end of the confidence interval of the Kaplan-Meier survival curve was not calculable because the proportion of participants who had progressive disease was too small.

SECONDARY outcome

Timeframe: At end of treatment (after 18 weeks treatment)

Population: 4/17 participants were analyzed because only 4 participants had evaluable Kaposi sarcoma.

Response was assessed by the percentage of participants with either a partial or complete response. Response was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria. Complete Response is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. The absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. Partial Response is a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or no new lesions occurring in previously uninvolved areas of the body.

Outcome measures

Outcome measures
Measure	All Participants n=4 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Response Assessment of Kaposi Sarcoma Using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria Reported Along With a 90% Confidence Interval	25 percentage of participants Interval 1.0 to 75.0

SECONDARY outcome

Timeframe: At end of treatment (after 18 weeks of treatment)

Population: 4/17 participants were analyzed because only 4 participants had evaluable Kaposi sarcoma.

Outcome measures

Outcome measures
Measure	All Participants n=4 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Response Assessment of Kaposi Sarcoma Using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria Reported Along With a 95% Confidence Interval	25 percentage of participants Interval 0.0 to 81.0

SECONDARY outcome

Timeframe: At end of treatment (after 18 weeks of treatment)

Population: 5/17 participants were analyzed because responses were only measured in participants with MCD.

Response rate is calculated by the percentage of participants with either a partial or complete response. Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to Kaposi sarcoma-associated herpesvirus (KSHV)-MCD must improve by the minimum amounts specified to attain PR (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion).

Outcome measures

Outcome measures
Measure	All Participants n=5 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 90% Confidence Interval	60 percentage of participants Interval 19.0 to 92.0

SECONDARY outcome

Timeframe: At end of treatment (after 18 weeks of treatment)

Population: 5/17 participants were analyzed because responses were only measured in participants with MCD.

Outcome measures

Outcome measures
Measure	All Participants n=5 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 95% Confidence Interval	60 percentage of participants Interval 15.0 to 95.0

SECONDARY outcome

Timeframe: At the end of treatment (after 18 weeks of treatment)

Population: This outcome was not done because the definition of KSHV-inflammatory Cytokine syndrome (KICS) has been updated to exclude participants with lymphoma and therefore, effect of the regimen on KICS cannot be performed.

Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to KICS, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to KICS must improve by the minimum amounts (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). Progressive disease (PD) is at least two indicator abnormalities must deteriorate by the minimum amounts specified below to constitute PD (e.g., C-reactive protein increase by ≥50% of baseline (or the upper limit of normal, whichever is greater); Hemoglobin decrement 2g/dL not otherwise explained; and Platelet decrement ≥25,000/mm\^3 not otherwise explained). Stable disease (SD) is no change in signs and symptoms of KICS that meet criteria for any of CR, PR or PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of treatment (after 18 weeks of treatment)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days)

Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in blood using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days)

Population: The objective of obtaining effusion-based PKs can only be done if effusions within a cavity are visible after treatment and safe to proceed. Safety is paramount in this Phase I study and therefore if there was no effusion and/or if it was not safe to sample based on investigator judgement, no samples could be obtained, and no PKs could be obtained to answer this objective. There is no data collected for this measure of effusion PKs.

Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in effusions using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days)

Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in CSF using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: First 6 weeks (2 cycles) of treatment

Population: 6/17 participants were analyzed because dose-limiting toxicity was only performed during phase I which was only 6 participants.

DLT's as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). DLT is defined as any grade 4 adverse event at least possibly related to lenalidomide and not probably or definitely related to human immunodeficiency virus (HIV) or a Kaposi sarcoma-associated herpesvirus (KSHV)associated malignancy resulting in a dose delay in etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) treatment \>2 weeks due to failure to resolve to grade 3 or lower. Any grade 3 cardiac toxicity that is at least possibly related to lenalidomide and not probably or definitely related to HIV or a KSHV-associated malignancy resulting in a dose delay in DA-EPOCH-R treatment \>2 weeks due to failure to resolve to grade 2 or lower. DLT's were used to determine whether to stop or hold therapy in an individual participant as well as to expand individual dose levels from 3 to 6 participants.

Outcome measures

Outcome measures
Measure	All Participants n=6 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Number of Participants With a Dose-limiting Toxicity (DLT)	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Median follow-up time was 26 months

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	17 Participants

Adverse Events

Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab

Serious events: 12 serious events

Other events: 17 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab n=17 participants at risk Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Blood and lymphatic system disorders Anemia	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Chills	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Dehydration	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Diarrhea	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Disease progression	17.6% 3/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Dizziness	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Dysphagia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Enterocolitis	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Fatigue	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Blood and lymphatic system disorders Febrile neutropenia	47.1% 8/17 • Number of events 14 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Fever	11.8% 2/17 • Number of events 6 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Injury, poisoning and procedural complications Fracture	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Hypotension	17.6% 3/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Hypothermia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Ileus	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Mucositis oral	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Neutrophil count decreased	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Sepsis	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Cardiac disorders Sinus tachycardia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Sore throat	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Syncope	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Thromboembolic event	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Typhlitis	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Urinary retention	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Urinary tract infection	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Urinary tract pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Vascular disorders - Other, DVT upper extremities, bilateral	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Vascular disorders - Other, Pulmonary emboly, LUL	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Vascular disorders - Other, Pulmonary emboly, RLL	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations White blood cell decreased	5.9% 1/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.

Other adverse events

Other adverse events
Measure	Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab n=17 participants at risk Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
General disorders General disorders and administration site conditions - Other, specify: Nodule, right breast	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders General disorders and administration site conditions - Other, specify: Rash forehead	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders General disorders and administration site conditions - Other, specify: Runny nose	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Headache	35.3% 6/17 • Number of events 14 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Hematuria	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Hot flashes	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hyperglycemia	47.1% 8/17 • Number of events 9 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hyperkalemia	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypermagnesemia	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypernatremia	23.5% 4/17 • Number of events 5 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hyperphosphatemia	29.4% 5/17 • Number of events 8 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypertriglyceridemia	82.4% 14/17 • Number of events 25 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hyperuricemia	35.3% 6/17 • Number of events 10 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypoalbuminemia	88.2% 15/17 • Number of events 43 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypocalcemia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypoglycemia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypokalemia	94.1% 16/17 • Number of events 71 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypomagnesemia	35.3% 6/17 • Number of events 12 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hyponatremia	82.4% 14/17 • Number of events 40 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Hypophosphatemia	29.4% 5/17 • Number of events 8 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Hypotension	17.6% 3/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Endocrine disorders Hypothyroidism	17.6% 3/17 • Number of events 5 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Infections and infestations - Other, specify: CMV viremia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Infections and infestations - Other, specify: Epiglottitis	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders General disorders and administration site conditions - Other, specify: Left Knee effusion	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Abdominal pain	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Activated partial thromboplastin time prolonged	5.9% 1/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Acute kidney injury	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Endocrine disorders Adrenal insufficiency	5.9% 1/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Alanine aminotransferase increased	41.2% 7/17 • Number of events 23 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Alkaline phosphatase increased	41.2% 7/17 • Number of events 26 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Alopecia	29.4% 5/17 • Number of events 6 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Anal pain	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Blood and lymphatic system disorders Anemia	94.1% 16/17 • Number of events 242 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Metabolism and nutrition disorders Anorexia	41.2% 7/17 • Number of events 10 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Psychiatric disorders Anxiety	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Musculoskeletal and connective tissue disorders Arthralgia	17.6% 3/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Aspartate aminotransferase increased	52.9% 9/17 • Number of events 28 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Cardiac disorders Atrial flutter	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Musculoskeletal and connective tissue disorders Back pain	17.6% 3/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Blood bilirubin increased	35.3% 6/17 • Number of events 18 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Blood lactate dehydrogenase increased	11.8% 2/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Eye disorders Blurred vision	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations CD4 lymphocytes decreased	88.2% 15/17 • Number of events 43 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations CPK increased	41.2% 7/17 • Number of events 11 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Cardiac disorders Cardiac arrest	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Cardiac disorders Cardiac disorders - Other, specify: Tachycardia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Cardiac disorders Cardiac disorders - Other, specify: shock	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Cardiac disorders Chest pain - cardiac	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Chills	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Cholesterol high	35.3% 6/17 • Number of events 8 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Colitis	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Psychiatric disorders Confusion	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Conjunctivitis	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Constipation	52.9% 9/17 • Number of events 12 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Cough	11.8% 2/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Creatinine increased	47.1% 8/17 • Number of events 20 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Psychiatric disorders Depression	17.6% 3/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Diarrhea	29.4% 5/17 • Number of events 7 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Dry skin	23.5% 4/17 • Number of events 6 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Dysphagia	17.6% 3/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Dyspnea	35.3% 6/17 • Number of events 7 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Dysuria	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify: Ear infection	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Edema limbs	23.5% 4/17 • Number of events 6 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Edema trunk	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Reproductive system and breast disorders Erectile dysfunction	5.9% 1/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Esophagitis	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Eye disorders Eye disorders - Other, specify: Photophobia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Fatigue	76.5% 13/17 • Number of events 33 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Blood and lymphatic system disorders Febrile neutropenia	17.6% 3/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Fever	47.1% 8/17 • Number of events 17 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Gastroesophageal reflux disease	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: Gastric obstruction	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders General disorders and administration site conditions - Other, specify: Body aches	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders General disorders and administration site conditions - Other, specify: Burning top of the feet	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders General disorders and administration site conditions - Other, specify: Facial rash	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders General disorders and administration site conditions - Other, specify: Imbalance	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify: DVT-LUA axillary/basilica vein	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Psychiatric disorders Insomnia	23.5% 4/17 • Number of events 7 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Lymphocyte count decreased	100.0% 17/17 • Number of events 306 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Malaise	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Memory impairment	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Mucositis oral	41.2% 7/17 • Number of events 16 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Nail discoloration	29.4% 5/17 • Number of events 6 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Nausea	58.8% 10/17 • Number of events 21 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Neutrophil count decreased	100.0% 17/17 • Number of events 191 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Oral pain	17.6% 3/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
General disorders Pain	47.1% 8/17 • Number of events 14 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Paresthesia	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Eye disorders Periorbital edema	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Peripheral motor neuropathy	11.8% 2/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Nervous system disorders Peripheral sensory neuropathy	52.9% 9/17 • Number of events 29 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Platelet count decreased	100.0% 17/17 • Number of events 174 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Pleural effusion	23.5% 4/17 • Number of events 8 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Proteinuria	52.9% 9/17 • Number of events 13 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Pruritus	23.5% 4/17 • Number of events 5 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Rash maculo-papular	17.6% 3/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Uric acid increased	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Urine protein increased	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Respiratory failure	17.6% 3/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify: Runny nose	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Sepsis	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Cardiac disorders Sinus tachycardia	11.8% 2/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Sinusitis	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Brittle nails	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Darkening of skin	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Skin infection	11.8% 2/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Skin and subcutaneous tissue disorders Skin ulceration	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Respiratory, thoracic and mediastinal disorders Stridor	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Thrush	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Upper respiratory infection	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Renal and urinary disorders Urinary frequency	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Infections and infestations Urinary tract infection	11.8% 2/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Vascular disorders - Other, specify: Pulmonary emboly, LUL	5.9% 1/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Vascular disorders Vascular disorders - Other, specify: Pulmonary emboly, RLL	5.9% 1/17 • Number of events 3 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Gastrointestinal disorders Vomiting	23.5% 4/17 • Number of events 4 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations Weight loss	0.00% 0/17 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Investigations White blood cell decreased	5.9% 1/17 • Number of events 5 • All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.

Additional Information

Dr. Ramya Ramaswami

National Cancer Institute

Phone: 240-506-1088

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place