Trial Outcomes & Findings for Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy (NCT NCT00691704)

Last Updated: 2014-08-19

Results Overview

Progression free survival (PFS) is defined for all subjects as the time from the date of initiation of treatment to the date of first documentation of relapse, progression, or death due to any cause. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). PFS survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

2 years

Results posted on

2014-08-19

Participant Flow

Recruitment began in July, 2008 and ended in October, 2010. Subjects were identified from Duke University Medical Center Hematologic Malignancies and Cellular Therapy program and University of North Carolina at Chapel Hill Lineberger Cancer Center for all demographic groups who meet the eligibility criteria.

Participant milestones

Participant milestones
Measure	High-risk Multiple Myeloma Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Induction Therapy STARTED	18
Induction Therapy COMPLETED	16
Induction Therapy NOT COMPLETED	2
Two Years of Maintenance Therapy STARTED	16
Two Years of Maintenance Therapy COMPLETED	3
Two Years of Maintenance Therapy NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	High-risk Multiple Myeloma Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Induction Therapy Disease Progression	1
Induction Therapy Active Hepatitis	1
Two Years of Maintenance Therapy Disease Progression	8
Two Years of Maintenance Therapy Physician Decision	4
Two Years of Maintenance Therapy Withdrawal by Subject	1

Baseline Characteristics

Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-risk Multiple Myeloma n=18 Participants Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Maintenance Therapy: Subjects who achieve \>partial response (PR) after induction will receive repeating triplet 28-day cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance: * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on Days 1-7 * Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Subjects enrolled and able to initiate induction therapy.

Outcome measures

Outcome measures
Measure	High-risk Multiple Myeloma n=18 Participants Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Progression Free Survival PFS at 2 years	3 participants
Progression Free Survival PFS at 1 year	9 participants

SECONDARY outcome

Timeframe: 6 months

Population: Subjects who responded to drug induction therapy.

Time to response will be measured in the population of subjects with a confirmed response as the time from the date of initiation of treatment to the date of the first documentation of a confirmed response. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). Time to response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	High-risk Multiple Myeloma n=16 Participants Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Time to Response	2 months Interval 1.5 to 5.0

SECONDARY outcome

Timeframe: 6 years

Population: Subjects who initiated drug therapy. Eleven patients are still alive as of 2/28/14.

Overall survival is defined as the time from the date of initiation of treatment to the date of death due to any cause. Overall response rate will be estimated with its 80% confidence interval, and the numbers of subjects achieving a sustained complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) will be tabulated. Overall survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	High-risk Multiple Myeloma n=18 Participants Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Overall Survival	36 months Interval 4.0 to 54.0

SECONDARY outcome

Timeframe: 6 years

Population: Subjects who experienced disease progression.

Time to progression (TTP) is defined for all patients as the time from initiation of treatment to disease progression with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006).

Outcome measures

Outcome measures
Measure	High-risk Multiple Myeloma n=12 Participants Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Time to Progression	11 months Interval 2.0 to 27.0

SECONDARY outcome

Timeframe: 6 years

The duration of response, defined only among the responders, is measured from start of achieving Partial Response (PR) \[first observation of PR before confirmation\] to the time of disease progression, with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). Duration of response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	High-risk Multiple Myeloma n=16 Participants Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Duration of Response	11 months Interval 1.0 to 25.0

Adverse Events

High-risk Multiple Myeloma

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High-risk Multiple Myeloma n=18 participants at risk Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Cardiac disorders Supraventricular and nodal arrhythmia	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Atrial Fibrillation	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Chest Pain	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Congestive Heart Failure	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Ventricular Tachycardia	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Cardiac Ischemia / infarction	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Cellulitis	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Acute Gastroenteritis	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Musculoskeletal and connective tissue disorders Muscular / skeletal hypoplasia	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Musculoskeletal and connective tissue disorders Musculoskeletal	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Pain - Other	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Vascular disorders Thrombosis / thrombus / embolism	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.

Other adverse events

Other adverse events
Measure	High-risk Multiple Myeloma n=18 participants at risk Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
Ear and labyrinth disorders Otitis, external ear (non-infectious)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders thrombosis	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Bacteremia	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Hemoglobin	27.8% 5/18 • Number of events 5 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders anemia	55.6% 10/18 • Number of events 10 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Leukocytes (total WBC)	83.3% 15/18 • Number of events 15 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders leukopenia	55.6% 10/18 • Number of events 10 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Lymphopenia	72.2% 13/18 • Number of events 13 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Lymphocytopenia	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Neutrophils / granulocytes (ANC / AGC)	100.0% 18/18 • Number of events 20 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Platelets	66.7% 12/18 • Number of events 12 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders thrombocytopenia	50.0% 9/18 • Number of events 9 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Cardiac General - Other (Specify, __)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Cardiac Arrest	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Hypotension	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Cardiac disorders Cardiac Left Ventricular Function	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Constitutional Symptoms - Other (Specify, __)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Decreased Libido	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Fatigue (asthenia, lethargy, malaise)	83.3% 15/18 • Number of events 15 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	55.6% 10/18 • Number of events 10 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Insomnia	55.6% 10/18 • Number of events 10 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Rigors / chills	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Sweating (diaphoresis)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Weight gain	16.7% 3/18 • Number of events 3 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Weight loss	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Dermatology / Skin - Other (Specify, __)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Folliculitis	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Cold sore - left upper lip	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Contact dermatitis	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Erythema	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Excoriation bilateral dorsal aspect of feet, related to scratching	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Hyperpigmentation - nailbeds	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Induration, CS	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Peeling skin, intermittent, NCS	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Redness-feet	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Right ankle erythema	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Dry Skin	16.7% 3/18 • Number of events 3 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Hair Loss / Alopecia (scalp or body)	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Pruritus / itching	44.4% 8/18 • Number of events 8 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Skin and subcutaneous tissue disorders Rash / desquamation	72.2% 13/18 • Number of events 13 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Endocrine disorders Hot flashes / flushes	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Anorexia	33.3% 6/18 • Number of events 6 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Constipation	44.4% 8/18 • Number of events 8 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Dehydration	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Diarrhea	61.1% 11/18 • Number of events 11 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Bleeding	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Bloating	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Heartburn / dyspepsia	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Nausea	55.6% 10/18 • Number of events 10 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Taste Alteration (dysgeusia)	16.7% 3/18 • Number of events 3 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Vomiting	27.8% 5/18 • Number of events 5 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Hemorrhage / Bleeding - Other (Specify, __)	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Infections and infestations Infection - Other (Cellulitis)	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Infections and infestations Upper respiratory infection	50.0% 9/18 • Number of events 9 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)	27.8% 5/18 • Number of events 5 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Blood and lymphatic system disorders Edema	100.0% 18/18 • Number of events 19 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Alkaline phosphatase	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders AST, SGOT (serum glutamic oxaloacetic transaminase)	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	38.9% 7/18 • Number of events 7 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	33.3% 6/18 • Number of events 6 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	16.7% 3/18 • Number of events 3 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Decreased Neutrophils	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Metabolism and nutrition disorders Uric Acid, serum-high (hyperuricemia)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Musculoskeletal and connective tissue disorders Joint-function	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	27.8% 5/18 • Number of events 5 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Musculoskeletal and connective tissue disorders Osteonecrosis (avascular necrosis)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Ataxia	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Parasthesias	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Mood Swings	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Cognitive disturbance	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Confusion	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Dizziness	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Mood Alteration - Anxiety	33.3% 6/18 • Number of events 6 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Mood Alteration - Depression	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Neuropathy: motor	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Neuropathy: sensory	55.6% 10/18 • Number of events 10 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Syncope (fainting)	27.8% 5/18 • Number of events 5 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Tremor	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Eye disorders Dry Eye Syndrome	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Eye disorders Ocular / Visual - Other (Specify, __)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Eye disorders Vision - blurred vision	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Gastrointestinal disorders Gastrointestinal	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Musculoskeletal and connective tissue disorders Musculoskeletal	100.0% 18/18 • Number of events 33 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Nervous system disorders Pain - General	22.2% 4/18 • Number of events 4 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Eye disorders Pain - Head / headache	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Eye disorders Pain - Other (Specify, __)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Cough	61.1% 11/18 • Number of events 11 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	38.9% 7/18 • Number of events 7 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Cyanosis of toes	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Pneumonitis / pulmonary infiltrates	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Pulmonary / Upper Respiratory - Other (Specify, __)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Respiratory, thoracic and mediastinal disorders Orthopnea	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Renal and urinary disorders Cystitis	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Renal and urinary disorders Renal / Genitourinary - Other (Specify, __)	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Renal and urinary disorders Malodorous urine	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Renal and urinary disorders Urinary frequency / urgency	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Dry mouth	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Early satiety, CS	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Esophageal spasms	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Food Aversions, CS	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Hiccups	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Increased thirst	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Oral lesion	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Bilateral facial swelling	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Paresthesias- Intermittent	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Right Breast Pressure	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Sore throat intermittent	11.1% 2/18 • Number of events 2 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
General disorders Sternal Discomfort	5.6% 1/18 • Number of events 1 • Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness. Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.

Additional Information

Cristina Gasparetto, MD

Duke University Medical Center

Phone: 919-668-1017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place