Trial Outcomes & Findings for Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma (NCT NCT02561273)

NCT ID: NCT02561273

Last Updated: 2023-12-13

Results Overview

MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2023-12-13

Participant Flow

Per the protocol, date of enrollment is defined as the date of consent. For this study 54 participants were consented. 10 were determined to be ineligible and not assigned to a study group.

Participant milestones

Measure	10 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant
Overall Study STARTED	40	4
Overall Study COMPLETED	39	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	10 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant
Overall Study Protocol Violation	1	0

Baseline Characteristics

Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	10 mg Lenalidomide Participants n=39 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	15 mg Lenalidomide Participants n=4 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	Total n=43 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 13 • n=5 Participants	62 years STANDARD_DEVIATION 4 • n=7 Participants	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	2 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	2 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	2 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	4 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Eight subjects were dosed at 10 mg dose and 4 subjects were dosed at 15 mg dose.

MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment.

Outcome measures

Measure	10 mg Lenalidomide Participants n=12 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP	10 milligrams	—

PRIMARY outcome

Timeframe: Up to 6 cycles of treatment (approximately 5 months)

Population: Toxicity was measured for all subjects dosed during Phase 1 of the study. 10 mg and 15 mg dose levels.

Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized.

Outcome measures

Measure	10 mg Lenalidomide Participants n=8 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	15 mg Lenalidomide Participants n=4 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 anemia	3 Participants	3 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 thrombocytopenia	2 Participants	3 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3,4 neutropenia fever	4 Participants	0 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 diarrhea	0 Participants	2 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 hyperglycemia	0 Participants	2 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 hypokalemia	0 Participants	1 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 hypotension	0 Participants	1 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 hyperbilirubinemia	0 Participants	1 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3, 4 mucositis	0 Participants	2 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3,4 nausea	0 Participants	2 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3,4 vomiting	0 Participants	1 Participants
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) grade 3,4 neutropenia	5 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to the completion of course 6 (18 weeks)

Population: Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.

A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner.

Outcome measures

Measure	10 mg Lenalidomide Participants n=39 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Complete Response Rate (Phase II)	49 percentage of participants Interval 33.0 to 64.0	—

PRIMARY outcome

Timeframe: Up to the completion of course 6 (18 weeks)

Population: Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.

The ORR will be estimated by the total number of patients who achieve a PR or CR at the end of six cycles of treatment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true ORR will be calculated.

Outcome measures

Measure	10 mg Lenalidomide Participants n=39 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Response Rate	69 percentage of participants Interval 54.0 to 81.0	—

SECONDARY outcome

Timeframe: Up to 1 year

Population: Safety data for the Intent to treat (ITT) group of subjects.

The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized.

39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.

Outcome measures

Measure	10 mg Lenalidomide Participants n=39 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3,4 neutropenia	27 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 leukopenia	25 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 thrombocytopenia	17 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 lymphopenia	18 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 febrile neutropenia	15 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 diarrhea	3 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 Peripheral sensory neuropathy	2 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 fatigue	1 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 nausea	1 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 anorexia	1 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 vomiting	1 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 anemia	17 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 mucositis oral	1 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 Rash maculo-papular	1 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 hypotension	1 Participants	—
Number of Participants With Adverse Events Graded According to CTC (Phase II) grade 3, 4 back pain	1 Participants	—

SECONDARY outcome

Timeframe: Time from registration to death due to any cause, assessed up to 1 year

Population: Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.

The distribution of overall survival will be estimated using the method of Kaplan-Meier.

Outcome measures

Measure	10 mg Lenalidomide Participants n=39 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Survival	89 percentage of participants Interval 74.0 to 96.0	—

SECONDARY outcome

Timeframe: Time from registration to progression or death due to any cause, assessed up to 2 years

Population: Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.

The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS rate at 2 years will be estimated. A 2-year PFS rate of 60% will be considered of interest.

Outcome measures

Measure	10 mg Lenalidomide Participants n=39 Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	15 mg Lenalidomide Participants Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	55 percentage of participants Interval 37.0 to 70.0	—

Adverse Events

Treatment (10 mg Lenalidomide)

Serious events: 14 serious events

Other events: 32 other events

Deaths: 9 deaths

Treatment (15 mg Lenalidomide)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Treatment (10 mg Lenalidomide) n=39 participants at risk Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	Treatment (15 mg Lenalidomide) n=4 participants at risk Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant
Blood and lymphatic system disorders Febrile neutropenia	35.9% 14/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Blood and lymphatic system disorders platelet count decreased	17.9% 7/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Blood and lymphatic system disorders Neutrophil count decreased	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders fever	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Blood and lymphatic system disorders anemia	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Infections and infestations sepsis	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders diarrhea	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Vascular disorders hypotension	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Respiratory, thoracic and mediastinal disorders pleural effusion	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Blood and lymphatic system disorders White blood cells decreased	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders Abdominal pain	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Infections and infestations Appendicitis	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Musculoskeletal and connective tissue disorders back pain	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations Blood bilirubin increased	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Cardiac disorders cardiac arrest	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders colitis	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations creatinine increased	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Respiratory, thoracic and mediastinal disorders dyspnea	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders Enterocolitis	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders fatigue	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders gastric hemorrhage	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders Ileus	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Infections and infestations Lung infection	2.6% 1/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T3 ADRENAL CORTICAL CARCINOMA	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders dizziness	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders gait disturbance	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Ear and labyrinth disorders hearing impaired	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders nausea	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders ACUTE ENCEPHALOPATHY	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders vomiting	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)

Other adverse events

Measure	Treatment (10 mg Lenalidomide) n=39 participants at risk Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant	Treatment (15 mg Lenalidomide) n=4 participants at risk Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant
General disorders Fatigue	82.1% 32/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	100.0% 4/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations White blood cell decreased	66.7% 26/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	75.0% 3/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations Neutrophil count decreased	64.1% 25/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	100.0% 4/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Skin and subcutaneous tissue disorders Alopecia	59.0% 23/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Blood and lymphatic system disorders Anemia	59.0% 23/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	75.0% 3/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations Lymphocyte count decreased	51.3% 20/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	100.0% 4/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations Platelet count decreased	46.2% 18/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	75.0% 3/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders Nausea	43.6% 17/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders diarrhea	41.0% 16/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders peripheral sensory neuropathy	41.0% 16/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders constipation	33.3% 13/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders dizziness	28.2% 11/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders Anorexia	25.6% 10/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders mucositis, oral	25.6% 10/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders Vomiting	25.6% 10/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Skin and subcutaneous tissue disorders rash maculo-papular	23.1% 9/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Respiratory, thoracic and mediastinal disorders cough	20.5% 8/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	75.0% 3/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Vascular disorders hypotension	20.5% 8/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Infections and infestations infections and infestation, Other	20.5% 8/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders general disorders -Other	17.9% 7/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders Abdominal pain	15.4% 6/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Musculoskeletal and connective tissue disorders back pain	15.4% 6/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Psychiatric disorders Anxiety	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders dysgeusia	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Respiratory, thoracic and mediastinal disorders dyspnea	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders headache	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Respiratory, thoracic and mediastinal disorders nasal congestion	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Skin and subcutaneous tissue disorders Other skin and subcutaneous tissue disorders	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations weight loss	12.8% 5/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders chills	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders fever	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders other gastrointestinal disorders	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders malaise	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Musculoskeletal and connective tissue disorders myalgia	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Musculoskeletal and connective tissue disorders neck pain	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders pain	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders syncope	10.3% 4/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Blood and lymphatic system disorders Other blood and lymphatic disorders	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Eye disorders dry eye	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders dysphagia	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders edema limbs	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hypoalbuminemia	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hypokalemia	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hyponatremia	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders Infusion related reaction	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders other nervous system disorders	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Respiratory, thoracic and mediastinal disorders other respiratory, thoracic and mediastinal disorders	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Cardiac disorders sinus tachycardia	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Respiratory, thoracic and mediastinal disorders sore throat	7.7% 3/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations blood bilirubin increased	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders dehydration	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Ear and labyrinth disorders external ear inflammation	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Injury, poisoning and procedural complications fall	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Gastrointestinal disorders gastroesophageal reflux disease	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hyperglycemia	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	50.0% 2/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Vascular disorders hypertension	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hypocalcemia	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hypophosphatemia	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Psychiatric disorders insomnia	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Vascular disorders lymphedema	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Musculoskeletal and connective tissue disorders other musculoskeletal and connective tissue disorders	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Skin and subcutaneous tissue disorders pain of skin	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Nervous system disorders peripheral motor neuropathy	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Skin and subcutaneous tissue disorders rash acneiform	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Renal and urinary disorders urinary frequency	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Infections and infestations urinary tract infection	5.1% 2/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	0.00% 0/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations Alkaline phosphatase increased	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Immune system disorders Allergic reaction	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Eye disorders blurred vision	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Investigations creatinine increased	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Skin and subcutaneous tissue disorders dry skin	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hypomagnesemia	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Metabolism and nutrition disorders hypermagnesemia	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
General disorders non-cardiac chest pain	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Injury, poisoning and procedural complications DRAINAGE FROM BIOPSY SITE	0.00% 0/39 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)	25.0% 1/4 • Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)

Additional Information

Matthew Lunning

University of Nebraska Medical Center

Phone: 402-559-7164

Email: mlunning@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place