A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma

• Sponsor: Celgene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01724177
• Collaborator: (none)
• Enrollment: 26
• Locations: 18
• Arm: 1
• Actual Duration (Months): 52.2
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.

Condition or Disease	Intervention/Treatment	Phase
Adult T-Cell Leukemia-Lymphoma	Drug: Lenalidomide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma
• Actual Study Start Date: Nov 12, 2012
• Actual Primary Completion Date: Nov 20, 2014
• Actual Study Completion Date: Mar 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lenalidomide Lenalidomide 25mg by mouth (PO) daily until progressive disease or unacceptable toxicity	Drug: Lenalidomide; 25 mg of Lenalidomide administered orally once daily; Other Names: Revlimid

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC) [From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks]

   ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared

Secondary Outcome Measures

1. Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC [From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks]

   PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.

2. Kaplan-Meier Estimate of Time to Progression (TTP) [From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks]

   Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC

3. Number of Participants With Treatment Emergent Adverse Events [From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks]

   Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.

4. Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC [From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks]

   The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.

5. Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC [From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks]

   The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.

6. Kaplan-Meier Estimate for Overall Survival [From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks]

   Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.

Other Outcome Measures

1. Time to Response [From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks]

   Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must understand and voluntarily sign the informed consent

• Aged 20 years or older (at the time of signing the informed consent)

• Have a documented diagnosis of either: acute-, lymphoma-, or unfavorable chronic-type adult T-cell leukemia-lymphoma

• Have received ≥1 prior anti-adult T-cell leukemia-lymphoma therapy, have achieved stable disease or better on their immediately prior therapy and have relapsed or progressed at the time of obtaining signed informed consent

• Subjects for whom at least 1 measurable lesion (measurable lesion of computed tomography scan, peripheral blood or skin lesion) is confirmed in the lesion assessment before registration

• Have an Eastern Cooperative Oncology Group performance status of 0 to 2 at registration

• Must be able to adhere to the study visit schedule and other protocol requirements

• Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Exclusion Criteria:

• Have a history of central nervous system involvement or present with central nervous system symptoms, and are diagnosed with central nervous system lymphoma by cerebrospinal fluid cytology examination, head computed tomography scan or brain magnetic resonance imaging during the screening

• Are pregnant or lactating

• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. Examples of such medical condition are, but are not limited to, as follows:

• Uncontrolled diabetes mellitus as defined by the investigator or sub-investigator

• Chronic congestive heart failure (New York Heart Association Class III or IV)

• Unstable angina pectoris, angioplasty, stenting, or myocardial infarction (within 6 months before starting the study drug)

• Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia (subjects with controlled atrial fibrillation that is asymptomatic are eligible for this study)

• Major surgery within 28 days of the start of study treatment

• Exhibit grade 4 neurological disorders

• Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic prophylaxis.

• Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs

• Known human immunodeficiency virus positivity

• Have hepatitis B surface antigen-positive, or hepatitis C virus anti-body positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen-negative, a hepatitis B virus deoxyribonucleic acid test should be performed and if positive the subject will be excluded

• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

• Have a history of allogenic stem cell transplantation

• Have received autologous stem cell transplantation within 12 weeks (84 days) of the start of study treatment

• Have previously used lenalidomide

• Have a history of desquamating (blistering) rash while taking thalidomide

• Have received any investigational drugs (unapproved drugs in Japan) within 4 weeks (28 days) of the start of study medication

• Have received any antibody agents within 12 weeks (84 days) of the start of study medication

• Have received chemotherapeutic agents or immunomodulatory drugs for the treatment of adult T-cell leukemia-lymphoma within 4 weeks (28 days) of the start of study treatment

• Have received radiotherapy within 4 weeks (28 days) of the start of study treatment

• Have a history or complication of another malignant tumor other than adult T-cell leukemia-lymphoma and the following malignant tumors, unless the patients have been free of the disease for 5 years or longer

• Basal cell carcinoma of the skin

• Squamous cell carcinoma of the skin

• Cervical carcinoma in situ

• Carcinoma in situ of the breast

• An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)

• Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection

• Have had any of the following abnormal measurements at screening performed within 1 week (7 days) prior to the registration;

• Neutrophil count: < 1,200/µL

• Platelet count: < 75,000/µL

• Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase or alanine aminotransferase/glutamyl pyruvic transaminase: > 3 times the upper limit of normal

• Bilirubin level: > 1.5 times the upper limit of normal

• Creatinine clearance: < 60 mL/min

• Any condition that confounds the ability to interpret data from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagoya City University Hospital	Nagoya	Aichi	Japan	467-8602
2	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277-8577
3	Ehime University Hospital	Toon	Ehime	Japan	791-0295
4	Iwate Medical University Hospital	Morioka	Iwate	Japan	020-8505
5	Tohoku University Hospital	Sendai	Miyagi	Japan	980-8574
6	Sasebo City General Hospital	Sasebo	Nagasaki	Japan	857-8511
7	Heart Life Hospital	Nakagami	Okinawa	Japan	901-2492
8	Shimane University Hospital	Izumo	Shimane	Japan	693-8501
9	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
10	Kyushu University Hospital	Fukuoka		Japan	812-8582
11	Imamura Bunin Hospital	Kagoshima		Japan	890-0064
12	Kagoshima University Medical and Dental Hospital	Kagoshima		Japan	890-8520
13	National Hospital Organization Kagoshima Medical Center	Kagoshima		Japan	892-0853
14	Kumamoto University Hospital	Kumamoto		Japan	860-8556
15	Nagasaki University Hospital	Nagasaki		Japan	852-8501
16	The Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki		Japan	852-8511
17	Oita Prefectual Hospital	Oita		Japan	870-8511
18	National Cancer Center Hospital	Tokyo		Japan	104-0045

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Toru Sasaki, Celgene K.K.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT01724177
• Other Study ID Numbers: CC-5013-ATLL-002
• First Posted: Nov 9, 2012
• Last Update Posted: May 29, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Celgene: Lenalidomide; ATL; ATLL
• Additional relevant MeSH terms: Lymphoma; Leukemia; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell; Lenalidomide

Study Results

Participant Flow

Pre-assignment Detail	This study included Japanese participants with relapsed or recurrent adult T-cell leukemia (ATL) who had previously received anti- ATL chemotherapy and who were categorized as having acute-lymphoma or unfavorable chronic-type ATL.

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
Period Title: Overall Study
STARTED	26
Safety Population	26
COMPLETED	0
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
Overall Participants	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.5 (7.20)
Sex: Female, Male (Count of Participants)
Female	12 46.2%
Male	14 53.8%
Eastern Cooperative Oncology Group (ECOG) Performance Status (Number) [Number]
0 = Fully Active	13 50%
1 = Restrictive but Ambulatory	9 34.6%
2 = Ambulatory but Unable to Work	4 15.4%
3 = Limited Self-Care	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)
Description	ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared
Time Frame	From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	26
Number (95% Confidence Interval) [percentage of participants]	42.3 162.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lenalidomide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest: H0: ORR ≤ 5% versus H1: ORR > 5%
	Method	Exact Test
	Comments

2. Secondary Outcome

Title	Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC
Description	PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.
Time Frame	From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks

Outcome Measure Data

Analysis Population Description

The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	26
Median (95% Confidence Interval) [weeks]	16.30

3. Secondary Outcome

Title	Kaplan-Meier Estimate of Time to Progression (TTP)
Description	Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC
Time Frame	From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks

Outcome Measure Data

Analysis Population Description

The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	26
Median (95% Confidence Interval) [weeks]	16.30

4. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events
Description	Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame	From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks

Outcome Measure Data

Analysis Population Description

Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	26
≥ 1 TEAE	26 100%
≥ 1 TEAE Related to Lenalidomide	26 100%
≥ 1 NCI CTCAE Grade (GR) 3 or Greater TEAE	25 96.2%
≥ 1 NCI CTCAE ≥ GR 3 TEAE Related to Lenalidomide	25 96.2%
≥ 1 Serious TEAE	11 42.3%
≥ 1 Serious TEAE Related to Lenalidomide	9 34.6%
≥ 1 TEAE Leading to Discontinuation	8 30.8%
≥ 1 Related TEAE Leading to Discontinuation	8 30.8%
≥ 1 TEAE Leading to Dose Reduction/Interruption	17 65.4%
≥ 1 related TEAE Leading to Decrease/Interruption	17 65.4%
≥ 1 TEAE Resulting in Death	0 0%

5. Secondary Outcome

Title	Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC
Description	The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.
Time Frame	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks

Outcome Measure Data

Analysis Population Description

The EE population who had a documented response and consisted of participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	11
Number (95% Confidence Interval) [weeks]	24.10

6. Other Pre-specified Outcome

Title	Time to Response
Description	Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)
Time Frame	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Outcome Measure Data

Analysis Population Description

Participants with a response of PR or better.

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	11
Median (Full Range) [weeks]	8.10

7. Secondary Outcome

Title	Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC
Description	The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.
Time Frame	From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Outcome Measure Data

Analysis Population Description

The EE population with a response (CR, CRu, PR or SD) and consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	26
Number (95% Confidence Interval) [percentage of participants]	73.1 281.2%

8. Secondary Outcome

Title	Kaplan-Meier Estimate for Overall Survival
Description	Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.
Time Frame	From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks

Outcome Measure Data

Analysis Population Description

The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.

Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
Measure Participants	26
Median (95% Confidence Interval) [weeks]	88.10

Adverse Events

Time Frame	From the first day of lenalidomide treatment through 28 days after the last dose of lenalidomide. up to clinical cut-off date of 19 May 2017; maximum duration of study drug was 130.4 weeks
Arm/Group Title	Lenalidomide
Arm/Group Description	Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
All Cause Mortality
	Lenalidomide
	Affected / at Risk (%)	# Events
Total	22/26 (84.6%)
Serious Adverse Events
	Lenalidomide
	Affected / at Risk (%)	# Events
Total	11/26 (42.3%)
Blood and lymphatic system disorders
Thrombocytopenia	2/26 (7.7%)
Anaemia	1/26 (3.8%)
Cardiac disorders
Acute left ventricular failure	1/26 (3.8%)
Ear and labyrinth disorders
Vertigo positional	1/26 (3.8%)
General disorders
Non-cardiac chest pain	1/26 (3.8%)
Pyrexia	1/26 (3.8%)
Hepatobiliary disorders
Acute hepatic failure	1/26 (3.8%)
Infections and infestations
Enterocolitis infectious	1/26 (3.8%)
Meningitis bacterial	1/26 (3.8%)
Pneumonia	1/26 (3.8%)
Sinusitis fungal	1/26 (3.8%)
Investigations
Blood pressure decreased	1/26 (3.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare	1/26 (3.8%)
Nervous system disorders
Syncope	1/26 (3.8%)
Transient ischaemic attack	1/26 (3.8%)
Renal and urinary disorders
Renal failure acute	1/26 (3.8%)
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema	1/26 (3.8%)
Skin and subcutaneous tissue disorders
Erythema multiforme	1/26 (3.8%)
Rash	2/26 (7.7%)
Toxic skin eruption	1/26 (3.8%)
Other (Not Including Serious) Adverse Events
	Lenalidomide
	Affected / at Risk (%)	# Events
Total	26/26 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	20/26 (76.9%)
Neutropenia	19/26 (73.1%)
Lymphopenia	18/26 (69.2%)
Anaemia	15/26 (57.7%)
Leukopenia	13/26 (50%)
Leukocytosis	5/26 (19.2%)
Basophilia	3/26 (11.5%)
Eosinophilia	3/26 (11.5%)
Disseminated intravascular coagulation	2/26 (7.7%)
Cardiac disorders
Bradycardia	2/26 (7.7%)
Supraventricular extrasystoles	2/26 (7.7%)
Gastrointestinal disorders
Constipation	8/26 (30.8%)
Nausea	7/26 (26.9%)
Vomiting	6/26 (23.1%)
Stomatitis	3/26 (11.5%)
Diarrhoea	2/26 (7.7%)
General disorders
Malaise	5/26 (19.2%)
Fatigue	4/26 (15.4%)
Pyrexia	4/26 (15.4%)
Oedema peripheral	2/26 (7.7%)
Hepatobiliary disorders
Hepatic function abnormal	6/26 (23.1%)
Hyperbilirubinaemia	2/26 (7.7%)
Immune system disorders
Hypogammaglobulinaemia	2/26 (7.7%)
Infections and infestations
Nasopharyngitis	4/26 (15.4%)
Pneumonia	2/26 (7.7%)
Upper respiratory tract infection	2/26 (7.7%)
Injury, poisoning and procedural complications
Contusion	2/26 (7.7%)
Fall	2/26 (7.7%)
Investigations
C-reactive protein increased	11/26 (42.3%)
Alanine aminotransferase increased	8/26 (30.8%)
Aspartate aminotransferase increased	7/26 (26.9%)
Blood alkaline phosphatase increased	5/26 (19.2%)
Blood urea increased	5/26 (19.2%)
Blood creatinine increased	4/26 (15.4%)
Differential white blood cell count abnormal	3/26 (11.5%)
Glucose urine present	3/26 (11.5%)
Blood lactate dehydrogenase increased	3/26 (11.5%)
Blood urine present	2/26 (7.7%)
Neutrophil count decreased	2/26 (7.7%)
Weight decreased	2/26 (7.7%)
Eosinophil count increased	2/26 (7.7%)
Basophil count increased	2/26 (7.7%)
Blood albumin decreased	2/26 (7.7%)
Metabolism and nutrition disorders
Hypoalbuminaemia	9/26 (34.6%)
Hypoproteinaemia	9/26 (34.6%)
Hypocalcaemia	8/26 (30.8%)
Hyponatraemia	9/26 (34.6%)
Hypophosphataemia	9/26 (34.6%)
Hypokalaemia	6/26 (23.1%)
Hyperkalaemia	4/26 (15.4%)
Hyperchloraemia	3/26 (11.5%)
Hypouricaemia	3/26 (11.5%)
Decreased appetite	2/26 (7.7%)
Dehydration	2/26 (7.7%)
Hyperglycaemia	2/26 (7.7%)
Hyperuricaemia	2/26 (7.7%)
Musculoskeletal and connective tissue disorders
Back pain	3/26 (11.5%)
Muscle spasms	2/26 (7.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare	3/26 (11.5%)
Nervous system disorders
Neuropathy peripheral	5/26 (19.2%)
Dysgeusia	3/26 (11.5%)
Psychiatric disorders
Insomnia	3/26 (11.5%)
Renal and urinary disorders
Proteinuria	2/26 (7.7%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/26 (7.7%)
Upper respiratory tract inflammation	2/26 (7.7%)
Skin and subcutaneous tissue disorders
Rash	6/26 (23.1%)
Pruritus	5/26 (19.2%)
Rash maculo-papular	3/26 (11.5%)
Drug eruption	2/26 (7.7%)
Dry skin	2/26 (7.7%)
Haemorrhage subcutaneous	2/26 (7.7%)
Toxic skin eruption	2/26 (7.7%)
Vascular disorders
Phlebitis	2/26 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Disclosure agreements varied; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor's prior written approval.