Trial Outcomes & Findings for Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma (NCT NCT00975806)

Last Updated: 2019-11-25

Results Overview

The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were: • Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in: * Grade (GR) 3 or 4 non-hematological toxicity lasting for ≥ 14 days * Febrile neutropenia * Gr 4 neutropenia lasting for ≥ 7 days * Gr 4 thrombocytopenia The occurrence of one of the above drug-related toxicities resulting in a clinical and/or laboratory assessment being done within 7 days following the initial finding to examine the participants for resolution of the toxicity. Lack of resolution of the toxicities was considered a DLT. If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Within 21 days of first dose of treatment

Results posted on

2019-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Study STARTED	5	7	4
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	5	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Study Adverse Event	2	1	2
Overall Study Disease Progression	1	5	1
Overall Study Withdrawal by Subject	1	0	0
Overall Study Death	0	1	0
Overall Study Physician decision and disease related	1	0	1

Baseline Characteristics

Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg n=5 Participants Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg n=7 Participants Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg n=4 Participants Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Total n=16 Participants Total of all reporting groups
Age, Continuous	55.0 years STANDARD_DEVIATION 18.84 • n=5 Participants	57.1 years STANDARD_DEVIATION 4.88 • n=7 Participants	57.3 years STANDARD_DEVIATION 5.62 • n=5 Participants	56.5 years STANDARD_DEVIATION 10.56 • n=4 Participants
Age, Customized ≤65 years	4 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	15 participants n=4 Participants
Age, Customized >65 years	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian (White)	4 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = fully active	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 = restricted activity but ambulatory	1 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 3 (Limited Self-Care)	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 4 (Completely Disabled)	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants

PRIMARY outcome

Timeframe: Within 21 days of first dose of treatment

Population: Safety population includes all participants who received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg n=16 Participants Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Phase 1: Maximum Tolerated Dose (MTD)	10 mg	—	—

PRIMARY outcome

Timeframe: After at least 3 cycles of treatment

Population: Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.

Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria: * Complete response-disappearance of all lesions * Partial response-30% decrease in the sum of diameters of target lesions from baseline * Stable disease-neither shrinkage nor increase of lesions. * Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively

Population: Safety population includes all participants who received at least one dose of study drug.

Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute \[NCI\] Common Toxicity Criteria for Adverse Events \[CTCAE\], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death

Outcome measures

Outcome measures
Measure	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg n=5 Participants Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg n=7 Participants Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg n=4 Participants Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib Participants with at least 1 TEAE	5 participants	7 participants	4 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib Participants with at least 1 serious TEAE	3 participants	4 participants	2 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 TEAE leading to stopping lenalidomide	2 participants	2 participants	2 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 TEAE leading to stopping sunitinib	2 participants	2 participants	2 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 TEAE -> dose reduction/interrruption of Len	5 participants	6 participants	4 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 TEAE dose reduction/interrruption of Sunitinib	5 participants	5 participants	3 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib Participants with ≥1 TEAE related to lenalidomide	5 participants	7 participants	4 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib Participants with ≥1 TEAE related to Sunitinib	5 participants	7 participants	4 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 NCI CTC Gr 3 or higher TEAE	5 participants	6 participants	4 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 NCI CTC Gr 3 or higher related to lenalidomide	4 participants	5 participants	4 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 NCI CTC Gr 3 or higher related to Sunitinib	4 participants	5 participants	4 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 serious TEAE related to lenalidomide	2 participants	2 participants	0 participants
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib ≥ 1 serious TEAE related to sunitinib	1 participants	2 participants	2 participants

SECONDARY outcome

Timeframe: Every 3 cycles; up to month 25

Population: Intent to Treat Population includes participants who took at least one dose of study drug. Study participants with stable disease also reported.

Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria: Treatment response includes both complete response and partial response * Complete response-disappearance of all lesions * Partial response-30% decrease in the sum of diameters of target lesions from baseline * Stable disease-neither shrinkage nor increase of lesions * Progressive Disease-20% increase in the sum of diameters of target lesions from nadir

Outcome measures

Outcome measures
Measure	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg n=5 Participants Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg n=7 Participants Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle	Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg n=4 Participants Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Phase 1 : Tumor Response Rate According to RECIST 1.1 Complete Response	0 participants	0 participants	0 participants
Phase 1 : Tumor Response Rate According to RECIST 1.1 Partial Response	1 participants	0 participants	0 participants
Phase 1 : Tumor Response Rate According to RECIST 1.1 Stable Disease	1 participants	3 participants	3 participants

SECONDARY outcome

Timeframe: Day 1 of study drug to disease progression or death

Population: Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including MTD, were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.

Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of initial response date to progressive disease

Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of study drug to death

Overall survival was defined as the time from the start of study drug therapy to death.

Outcome measures

Outcome data not reported

Adverse Events

Cohort A

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort F

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort G

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Anne McClain,Senior Manager

Celgene Corporation

Phone: 1-888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Multicenter publications must include input from investigators and Celgene, and agreement be established before publication. Results from a center cannot be submitted for publication prior to a multicenter publication unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene ≤ 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ≤ 90 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort A n=5 participants at risk Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle	Cohort F n=7 participants at risk Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle	Cohort G n=4 participants at risk Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
Blood and lymphatic system disorders Anaemia	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Blood and lymphatic system disorders Leukopenia	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Blood and lymphatic system disorders Thrombocytopenia	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Cardiac disorders Atrial Fibrillation	0.00% 0/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	25.0% 1/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	14.3% 1/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Gastrointestinal disorders Pancreatitis	0.00% 0/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	25.0% 1/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
General disorders Asthenia	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
General disorders General Physical Health Deterioration	0.00% 0/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	14.3% 1/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
General disorders Influenza Like Illness	0.00% 0/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	14.3% 1/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Immune system disorders Hypersensitivity	0.00% 0/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	14.3% 1/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Infections and infestations Device related infection	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Infections and infestations Urinary Tract Infection	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Respiratory, thoracic and mediastinal disorders Pleural Effusion	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	14.3% 1/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Vascular disorders Deep Vein Thrombosis	20.0% 1/5 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/7 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib	0.00% 0/4 • Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued. Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib