Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer (Mainsail)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00988208

Recruitment Status : Completed

First Posted : October 2, 2009

Results First Posted : September 5, 2013

Last Update Posted : April 4, 2018

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Celgene

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Prostate Cancer
Interventions	Drug: Lenalidomide Drug: Docetaxel Drug: Prednisone Drug: Placebo
Enrollment	1059

Participant Flow

Recruitment Details	Following a safety and efficacy data review by the Data Monitoring Committee( DMC), the trial was stopped for futility. At that time, 1059 participants had been randomized and 1046 treated with either lenalidomide plus docetaxel and prednisone or placebo plus docetaxel and prednisone. A data cutoff date of 13 January 2012 was established.
Pre-assignment Details	Participants who had started a treatment cycle at the time of termination request were allowed to complete the cycle and have their discontinuation visit at the next cycle (21 days later). The safety follow-up of 28 days was also added to ensure all adverse events were followed.


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Period Title: Overall Study
Started	526	533
Treated	521	525
Completed	95 ^[1]	95 ^[2]
Not Completed	431	438
Reason Not Completed
Adverse Event	71	122
Disease Progression	103	89
Withdrawal by Subject	50	57
Death	9	15
Lost to Follow-up	2	3
Protocol Violation	9	2
Sponsor Decision	102	78
Clinical Progression	17	16
Biochemical Progression	21	7
Clinical Deterioration	7	14
Subject Decision/Investigator Discretion	32	32
Other	8	3
[1] DP Completed = kept on treatment with docetaxel/prednisone; Placebo was discontinued in DP arm [2] DPL Completed = kept on treatment with docetaxel/prednisone; Lenalidomide discontinued in DPL arm

Baseline Characteristics

Arm/Group Title		Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)	Total
Arm/Group Description		Participants received docetaxel 75 ...	Participants received docetaxel 75 ...	Total of all reporting groups
Arm/Group Description		Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Total of all reporting groups
Overall Number of Baseline Participants		526	533	1059
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Includes those from the Intent to Treat population (ITT). The ITT population is defined as all participants who were randomized, independent of whether they received study treatment or not.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	526 participants	533 participants	1059 participants
		68.4 (7.79)	68.9 (7.98)	68.7 (7.89)
Age, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	<65 years	171 32.5%	163 30.6%	334 31.5%
	> = to 65 years and < = 75years	246 46.8%	244 45.8%	490 46.3%
	>75 years	109 20.7%	126 23.6%	235 22.2%
Sex/Gender, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	526 participants	533 participants	1059 participants
male		526	533	1059
female		0	0	0
Region of Enrollment ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	US or Canada	136 25.9%	140 26.3%	276 26.1%
	EU or Australia	329 62.5%	330 61.9%	659 62.2%
	Rest of World (Includes 4 additional countries)	61 11.6%	63 11.8%	124 11.7%
		[1] Measure Description: Rest of World includes Israel, Russia, Mexico and South Africa
Race, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	White	433 82.3%	436 81.8%	869 82.1%
	Other or no answer	55 10.5%	67 12.6%	122 11.5%
	Black or African American	25 4.8%	21 3.9%	46 4.3%
	Asian	8 1.5%	6 1.1%	14 1.3%
	American Indian or Alaska Native	5 1.0%	3 0.6%	8 0.8%
Weight Mean (Standard Deviation) Unit of measure: Kilograms
	Number Analyzed	526 participants	533 participants	1059 participants
		86.4 (16.18)	86 (15.70)	86.2 (15.93)
Height Mean (Standard Deviation) Unit of measure: Centimeters
	Number Analyzed	526 participants	533 participants	1059 participants
		174.0 (7.81)	174.4 (7.38)	174.2 (7.60)
Body Mass Index ^[1] Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	526 participants	533 participants	1059 participants
		28.6 (5.02)	28.3 (4.60)	28.4 (4.81)
		[1] Measure Description: BMI or body mass index is a statistical benchmark that compares an individual's height and weight.
Body Mass Index, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	<25 kg/m^2	134 25.5%	138 25.9%	272 25.7%
	25-30 kg/m^2	221 42.0%	243 45.6%	464 43.8%
	>30 kg/m^2	171 32.5%	152 28.5%	323 30.5%
ECOG Performance Status ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	0 (Fully Active)	257 48.9%	252 47.3%	509 48.1%
	1 (Restrictive but ambulatory)	247 47.0%	256 48.0%	503 47.5%
	2 (Ambulatory but unable to work)	21 4.0%	24 4.5%	45 4.2%
	3 (Limited self-care)	1 0.2%	0 0.0%	1 0.1%
	Not specified	0 0.0%	1 0.2%	1 0.1%
		[1] Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient and determine appropriate treatment and prognosis.
Type of Disease Progression ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	Rising PSA only	146 27.8%	159 29.8%	305 28.8%
	Radiographic progression	380 72.2%	374 70.2%	754 71.2%
		[1] Measure Description: Categories of specific indicators of disease progression type
Prior Radiotherapy ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	Yes	308 58.6%	312 58.5%	620 58.5%
	No	218 41.4%	221 41.5%	439 41.5%
		[1] Measure Description: Participants who had been treated with prior radiation therapy
Prior Cancer Surgery ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	Yes	335 63.7%	358 67.2%	693 65.4%
	No	191 36.3%	175 32.8%	366 34.6%
		[1] Measure Description: Participants who had undergone a surgical procedure associated with their prostate cancer diagnosis prior to study participation
Other Prior Anti-Cancer Therapy ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	Yes	79 15.0%	71 13.3%	150 14.2%
	No	447 85.0%	462 86.7%	909 85.8%
		[1] Measure Description: Participants who were treated with other types of anti-cancer therapies prior to participation in study
Baseline PSA (Prostate Specific Antigen) Levels ^[1] Mean (Standard Deviation) Unit of measure: (ng/ml)
	Number Analyzed	526 participants	533 participants	1059 participants
		290.359 (659.1583)	316.501 (776.1133)	303.542 (720.2895)
		[1] Measure Description: Prostate-specific antigen (PSA) is a substance produced by the prostate gland. Elevated PSA levels may indicate prostate cancer or a noncancerous condition such as prostatitis or an enlarged prostate.
Metastatic Sites of Disease Outside of Prostate ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	526 participants	533 participants	1059 participants
	Bone only	157 29.8%	169 31.7%	326 30.8%
	Soft tissues only	94 17.9%	104 19.5%	198 18.7%
	Both bone and Soft tissues	273 51.9%	259 48.6%	532 50.2%
	None	2 0.4%	1 0.2%	3 0.3%
		[1] Measure Description: Specific sites of the body that have advanced spread of the prostate cancer.

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	Overall survival (OS) was the time from the date of randomization to t...
Description	Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.
Time Frame	From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population defined as all randomized patients irrespective of whether they received treatment or not.


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description:	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description:	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed	526	533
Median (95% Confidence Interval) Unit of Measure: weeks
	NA ^[1] (75.71 to NA)	77 (64.29 to 81.71)

[1]

Median overall survival was not reached for the DP arm as only 92 (17.5 %) of participants had died at the time of the data cut off.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel/Prednisone/Placebo (DP), Docetaxel/Prednisone/Lenalidomide (DPL)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0017
	Comments	p-value is based on unstratified log-rank test
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.53
	Confidence Interval	(2-Sided) 95% 1.17 to 2.00
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-Free Survival (PFS)
Description	PFS was the time from randomization to disease progression, or death, ...
Description	PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan
Time Frame	From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months

Outcome Measure Data

Analysis Population Description

Based on the Intent to treat population (ITT), defined as all randomized patients irrespective of whether they received treatment or not.


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description:	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description:	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed	526	533
Median (95% Confidence Interval) Unit of Measure: Weeks
	46 (42.14 to 53.57)	45 (38.0 to 46.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel/Prednisone/Placebo (DP), Docetaxel/Prednisone/Lenalidomide (DPL)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0187
	Comments	[Not Specified]
	Method	Log Rank
	Comments	P-value is based on unstratified log-rank test

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95% 1.05 to 1.66
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
Description	Objective response (OR) is defined as having complete response (CR) or...
Description	Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones
Time Frame	From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months

Outcome Measure Data

Analysis Population Description

Based on the ITT population


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description:	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description:	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed	526	533
Measure Type: Number Unit of Measure: percentage of participants
	24.3	22.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel/Prednisone/Placebo (DP), Docetaxel/Prednisone/Lenalidomide (DPL)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3975
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.884
	Confidence Interval	(2-Sided) 95% 0.665 to 1.176
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Number of Participants With Treatment Emergent Adverse Events (AEs)
Description	A TEAE is defined as any AE occurring or worsening on or after the fir...
Description	A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
Time Frame	From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL

Outcome Measure Data

Analysis Population Description

The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description:	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description:	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed	521	525
Measure Type: Number Unit of Measure: participants
Any TEAE	512	517
Any TEAE related to lenalidomide or placebo	379	412
Any TEAE related to docetaxel/prednisone	475	481
Any severity grade 3-4 TEAE	303	381
Any serious AE (SAE)	171	279
Any SAE related to lenalidomide or placebo	62	167
Any SAE related to docetaxel/prednisone	86	182
Any AE causing discontinuation of lenalidomide/PBO	82	150
Any AE causing withdrawal of docetaxel/prednisone	127	169
Any TEAE leading to death	16	24

5.Secondary Outcome


Title	Percentage of Participants Who Received Post-Study Therapies
Description	Percentage of Participants Who Received Post-Study Therapies for advan...
Description	Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.
Time Frame	The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017

Outcome Measure Data

Analysis Population Description

The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description:	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description:	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed	521	525
Measure Type: Number Unit of Measure: Percentage of Participants
	70.8	69.0

6.Secondary Outcome


Title	Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
Description	Second primary malignancies were monitored as events of interest and r...
Description	Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.
Time Frame	The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days

Outcome Measure Data

Analysis Population Description

The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment lenalidomide/placebo, Docetaxel, or Prednisone).


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description:	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description:	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed	521	525
Measure Type: Number Unit of Measure: percentage of participants
Invasive Secondary Primary Malignancies	1.3	1.7
Non-invasive Secondary Primary Malignancies	0.4	1.0

7.Secondary Outcome


Title	Time to Onset of Secondary Primary Malignancies
Description	Time of Onset of Secondary Primary Malignancies was considered an even...
Description	Time of Onset of Secondary Primary Malignancies was considered an event of interest
Time Frame	The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days

Outcome Measure Data

Analysis Population Description

The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).


Arm/Group Title	Docetaxel/Prednisone/Placebo (DP)	Docetaxel/Prednisone/Lenalidomide (DPL)
Arm/Group Description:	Participants received docetaxel 75 ...	Participants received docetaxel 75 ...
Arm/Group Description:	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed	521	525
Median (Full Range) Unit of Measure: months
	29.7 (0.6 to 48.7)	19.7 (3.7 to 65.0)

Adverse Events

Time Frame	From first dose of study treatment to 28 days after the last dose; as of the final analysis cut-off of 20 April 2017; median overall duration of treatment was 22.1 months for DPL and 27.0 months for the DP group
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Docetaxel/Prednisone/Lenalidomide (DPL)	Docetaxel/ Prednisone/and Placebo (DP)
Arm/Group Description	Participants received docetaxel 75 ...	Participants received Docetaxel 75 ...
Arm/Group Description	Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.	Participants received Docetaxel 75 mg/m^2 by intravenous (IV) administration over 30-60 minutes on Day 1, Prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
All-Cause Mortality
	Docetaxel/Prednisone/Lenalidomide (DPL)	Docetaxel/ Prednisone/and Placebo (DP)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Docetaxel/Prednisone/Lenalidomide (DPL)	Docetaxel/ Prednisone/and Placebo (DP)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	283/525 (53.90%)	176/521 (33.78%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	18/525 (3.43%)	12/521 (2.30%)
DISSEMINATED INTRAVASCULAR COAGULATION ^† 1	0/525 (0.00%)	1/521 (0.19%)
FEBRILE BONE MARROW APLASIA ^† 1	2/525 (0.38%)	1/521 (0.19%)
FEBRILE NEUTROPENIA ^† 1	52/525 (9.90%)	23/521 (4.41%)
LEUKOPENIA ^† 1	5/525 (0.95%)	6/521 (1.15%)
LYMPHOPENIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
NEUTROPENIA ^† 1	32/525 (6.10%)	11/521 (2.11%)
PANCYTOPENIA ^† 1	4/525 (0.76%)	0/521 (0.00%)
THROMBOCYTOPENIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
THROMBOTIC THROMBOCYTOPENIC PURPURA ^† 1	1/525 (0.19%)	0/521 (0.00%)
Cardiac disorders
ACUTE CORONARY SYNDROME ^† 1	2/525 (0.38%)	1/521 (0.19%)
ACUTE MYOCARDIAL INFARCTION ^† 1	1/525 (0.19%)	2/521 (0.38%)
ANGINA PECTORIS ^† 1	1/525 (0.19%)	1/521 (0.19%)
ANGINA UNSTABLE ^† 1	1/525 (0.19%)	0/521 (0.00%)
ARRHYTHMIA ^† 1	2/525 (0.38%)	0/521 (0.00%)
ATRIAL FIBRILLATION ^† 1	14/525 (2.67%)	8/521 (1.54%)
ATRIAL FLUTTER ^† 1	1/525 (0.19%)	0/521 (0.00%)
ATRIAL TACHYCARDIA ^† 1	1/525 (0.19%)	1/521 (0.19%)
ATRIAL THROMBOSIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
ATRIOVENTRICULAR BLOCK COMPLETE ^† 1	1/525 (0.19%)	0/521 (0.00%)
BRADYCARDIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
CARDIAC ARREST ^† 1	1/525 (0.19%)	0/521 (0.00%)
CARDIAC FAILURE ^† 1	0/525 (0.00%)	2/521 (0.38%)
CARDIAC FAILURE CONGESTIVE ^† 1	2/525 (0.38%)	1/521 (0.19%)
CARDIO-RESPIRATORY ARREST ^† 1	1/525 (0.19%)	0/521 (0.00%)
CARDIOGENIC SHOCK ^† 1	1/525 (0.19%)	0/521 (0.00%)
CARDIOVASCULAR DISORDER ^† 1	1/525 (0.19%)	0/521 (0.00%)
CORONARY ARTERY DISEASE ^† 1	1/525 (0.19%)	0/521 (0.00%)
CORONARY ARTERY OCCLUSION ^† 1	0/525 (0.00%)	1/521 (0.19%)
DIASTOLIC DYSFUNCTION ^† 1	0/525 (0.00%)	1/521 (0.19%)
DILATATION VENTRICULAR ^† 1	1/525 (0.19%)	0/521 (0.00%)
MYOCARDIAL INFARCTION ^† 1	3/525 (0.57%)	1/521 (0.19%)
PALPITATIONS ^† 1	1/525 (0.19%)	0/521 (0.00%)
PERICARDIAL EFFUSION ^† 1	1/525 (0.19%)	0/521 (0.00%)
RIGHT VENTRICULAR FAILURE ^† 1	1/525 (0.19%)	0/521 (0.00%)
SUPRAVENTRICULAR TACHYCARDIA ^† 1	0/525 (0.00%)	1/521 (0.19%)
TACHYARRHYTHMIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
TACHYCARDIA PAROXYSMAL ^† 1	0/525 (0.00%)	1/521 (0.19%)
VENTRICULAR EXTRASYSTOLES ^† 1	0/525 (0.00%)	1/521 (0.19%)
Ear and labyrinth disorders
MENIERE'S DISEASE ^† 1	1/525 (0.19%)	0/521 (0.00%)
Endocrine disorders
ADRENAL INSUFFICIENCY ^† 1	1/525 (0.19%)	0/521 (0.00%)
Gastrointestinal disorders
ABDOMINAL PAIN ^† 1	2/525 (0.38%)	2/521 (0.38%)
ABDOMINAL PAIN UPPER ^† 1	1/525 (0.19%)	1/521 (0.19%)
ANAL FISTULA ^† 1	0/525 (0.00%)	1/521 (0.19%)
ANAL HAEMORRHAGE ^† 1	1/525 (0.19%)	1/521 (0.19%)
ANAL ULCER ^† 1	0/525 (0.00%)	1/521 (0.19%)
COLITIS ISCHAEMIC ^† 1	1/525 (0.19%)	0/521 (0.00%)
CONSTIPATION ^† 1	4/525 (0.76%)	2/521 (0.38%)
DIARRHOEA ^† 1	22/525 (4.19%)	5/521 (0.96%)
DIARRHOEA HAEMORRHAGIC ^† 1	1/525 (0.19%)	0/521 (0.00%)
DIVERTICULUM ^† 1	0/525 (0.00%)	1/521 (0.19%)
DUODENAL ULCER ^† 1	1/525 (0.19%)	0/521 (0.00%)
DUODENAL ULCER HAEMORRHAGE ^† 1	0/525 (0.00%)	1/521 (0.19%)
ENTEROCOLITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
ENTEROVESICAL FISTULA ^† 1	1/525 (0.19%)	0/521 (0.00%)
FAECALOMA ^† 1	1/525 (0.19%)	0/521 (0.00%)
FEMORAL HERNIA, OBSTRUCTIVE ^† 1	1/525 (0.19%)	0/521 (0.00%)
GASTRIC HAEMORRHAGE ^† 1	1/525 (0.19%)	1/521 (0.19%)
GASTROINTESTINAL HAEMORRHAGE ^† 1	0/525 (0.00%)	2/521 (0.38%)
GASTROINTESTINAL PERFORATION ^† 1	1/525 (0.19%)	0/521 (0.00%)
GASTROINTESTINAL ULCER HAEMORRHAGE ^† 1	1/525 (0.19%)	0/521 (0.00%)
HAEMATEMESIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
INTESTINAL INFARCTION ^† 1	1/525 (0.19%)	0/521 (0.00%)
INTESTINAL OBSTRUCTION ^† 1	3/525 (0.57%)	2/521 (0.38%)
INTESTINAL PERFORATION ^† 1	1/525 (0.19%)	0/521 (0.00%)
LARGE INTESTINE PERFORATION ^† 1	0/525 (0.00%)	1/521 (0.19%)
LOWER GASTROINTESTINAL HAEMORRHAGE ^† 1	0/525 (0.00%)	1/521 (0.19%)
MELAENA ^† 1	0/525 (0.00%)	1/521 (0.19%)
NAUSEA ^† 1	4/525 (0.76%)	2/521 (0.38%)
OESOPHAGEAL ULCER ^† 1	0/525 (0.00%)	1/521 (0.19%)
PANCREATITIS ^† 1	0/525 (0.00%)	2/521 (0.38%)
RECTAL HAEMORRHAGE ^† 1	2/525 (0.38%)	4/521 (0.77%)
RETROPERITONEAL HAEMATOMA ^† 1	0/525 (0.00%)	1/521 (0.19%)
SMALL INTESTINAL OBSTRUCTION ^† 1	2/525 (0.38%)	1/521 (0.19%)
SUBILEUS ^† 1	1/525 (0.19%)	0/521 (0.00%)
UPPER GASTROINTESTINAL HAEMORRHAGE ^† 1	0/525 (0.00%)	2/521 (0.38%)
VOMITING ^† 1	8/525 (1.52%)	3/521 (0.58%)
General disorders
ASTHENIA ^† 1	5/525 (0.95%)	2/521 (0.38%)
CHILLS ^† 1	1/525 (0.19%)	0/521 (0.00%)
DEATH ^† 1	0/525 (0.00%)	1/521 (0.19%)
DEVICE OCCLUSION ^† 1	0/525 (0.00%)	2/521 (0.38%)
FATIGUE ^† 1	4/525 (0.76%)	2/521 (0.38%)
GAIT DISTURBANCE ^† 1	0/525 (0.00%)	1/521 (0.19%)
GENERAL PHYSICAL HEALTH DETERIORATION ^† 1	11/525 (2.10%)	5/521 (0.96%)
GENERALISED OEDEMA ^† 1	1/525 (0.19%)	0/521 (0.00%)
MALAISE ^† 1	1/525 (0.19%)	0/521 (0.00%)
MULTI-ORGAN FAILURE ^† 1	1/525 (0.19%)	1/521 (0.19%)
NON-CARDIAC CHEST PAIN ^† 1	4/525 (0.76%)	2/521 (0.38%)
OEDEMA PERIPHERAL ^† 1	0/525 (0.00%)	2/521 (0.38%)
PAIN ^† 1	1/525 (0.19%)	0/521 (0.00%)
PERFORMANCE STATUS DECREASED ^† 1	1/525 (0.19%)	0/521 (0.00%)
PYREXIA ^† 1	19/525 (3.62%)	6/521 (1.15%)
THROMBOSIS IN DEVICE ^† 1	1/525 (0.19%)	0/521 (0.00%)
Hepatobiliary disorders
CHOLECYSTITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
CHOLECYSTITIS ACUTE ^† 1	1/525 (0.19%)	0/521 (0.00%)
CHOLELITHIASIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
GALLBLADDER PERFORATION ^† 1	1/525 (0.19%)	0/521 (0.00%)
HYPERBILIRUBINAEMIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
Immune system disorders
DRUG HYPERSENSITIVITY ^† 1	3/525 (0.57%)	1/521 (0.19%)
Infections and infestations
ABDOMINAL ABSCESS ^† 1	0/525 (0.00%)	1/521 (0.19%)
ABSCESS BACTERIAL ^† 1	1/525 (0.19%)	1/521 (0.19%)
ABSCESS JAW ^† 1	1/525 (0.19%)	0/521 (0.00%)
ANAL ABSCESS ^† 1	1/525 (0.19%)	0/521 (0.00%)
APPENDICITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
APPENDICITIS PERFORATED ^† 1	0/525 (0.00%)	1/521 (0.19%)
BACTERAEMIA ^† 1	2/525 (0.38%)	1/521 (0.19%)
BRONCHITIS ^† 1	2/525 (0.38%)	0/521 (0.00%)
BRONCHOPNEUMONIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
CAMPYLOBACTER GASTROENTERITIS ^† 1	1/525 (0.19%)	1/521 (0.19%)
CANDIDIASIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
CELLULITIS ^† 1	3/525 (0.57%)	3/521 (0.58%)
CLOSTRIDIUM DIFFICILE COLITIS ^† 1	2/525 (0.38%)	0/521 (0.00%)
DEVICE RELATED INFECTION ^† 1	2/525 (0.38%)	0/521 (0.00%)
DIARRHOEA INFECTIOUS ^† 1	0/525 (0.00%)	1/521 (0.19%)
DIVERTICULITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
ENTEROCOLITIS INFECTIOUS ^† 1	1/525 (0.19%)	0/521 (0.00%)
ERYSIPELAS ^† 1	0/525 (0.00%)	1/521 (0.19%)
ESCHERICHIA SEPSIS ^† 1	1/525 (0.19%)	1/521 (0.19%)
ESCHERICHIA URINARY TRACT INFECTION ^† 1	1/525 (0.19%)	0/521 (0.00%)
GASTROENTERITIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
GROIN ABSCESS ^† 1	1/525 (0.19%)	0/521 (0.00%)
H1N1 INFLUENZA ^† 1	1/525 (0.19%)	0/521 (0.00%)
HERPES ZOSTER ^† 1	1/525 (0.19%)	0/521 (0.00%)
HORDEOLUM ^† 1	0/525 (0.00%)	1/521 (0.19%)
INCISION SITE CELLULITIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
INFECTIOUS PERITONITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
INFECTIVE TENOSYNOVITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
LOWER RESPIRATORY TRACT INFECTION ^† 1	2/525 (0.38%)	1/521 (0.19%)
LUNG INFECTION ^† 1	4/525 (0.76%)	0/521 (0.00%)
LYMPHANGITIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
NECROTISING FASCIITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
NEUTROPENIC INFECTION ^† 1	2/525 (0.38%)	1/521 (0.19%)
NEUTROPENIC SEPSIS ^† 1	15/525 (2.86%)	6/521 (1.15%)
ORAL CANDIDIASIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
ORAL INFECTION ^† 1	1/525 (0.19%)	0/521 (0.00%)
OSTEOMYELITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
PNEUMOCYSTIS JIROVECI PNEUMONIA ^† 1	2/525 (0.38%)	0/521 (0.00%)
PNEUMONIA ^† 1	24/525 (4.57%)	8/521 (1.54%)
PNEUMONIA BACTERIAL ^† 1	0/525 (0.00%)	1/521 (0.19%)
PNEUMONIA INFLUENZAL ^† 1	1/525 (0.19%)	0/521 (0.00%)
PNEUMONIA LEGIONELLA ^† 1	1/525 (0.19%)	0/521 (0.00%)
PSEUDOMONAL BACTERAEMIA ^† 1	1/525 (0.19%)	1/521 (0.19%)
PSEUDOMONAL SEPSIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
PYELONEPHRITIS ^† 1	1/525 (0.19%)	1/521 (0.19%)
RECTAL ABSCESS ^† 1	1/525 (0.19%)	0/521 (0.00%)
RESPIRATORY SYNCYTIAL VIRUS INFECTION ^† 1	1/525 (0.19%)	0/521 (0.00%)
RESPIRATORY TRACT INFECTION ^† 1	1/525 (0.19%)	1/521 (0.19%)
RESPIRATORY TRACT INFECTION BACTERIAL ^† 1	0/525 (0.00%)	1/521 (0.19%)
SEPSIS ^† 1	3/525 (0.57%)	9/521 (1.73%)
SEPTIC SHOCK ^† 1	3/525 (0.57%)	1/521 (0.19%)
SINUSITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
SKIN INFECTION ^† 1	2/525 (0.38%)	0/521 (0.00%)
STREPTOCOCCAL INFECTION ^† 1	0/525 (0.00%)	1/521 (0.19%)
TONSILLITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
UPPER RESPIRATORY TRACT INFECTION ^† 1	2/525 (0.38%)	0/521 (0.00%)
URETHRITIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
URINARY TRACT INFECTION ^† 1	10/525 (1.90%)	7/521 (1.34%)
URINARY TRACT INFECTION BACTERIAL ^† 1	1/525 (0.19%)	1/521 (0.19%)
URINARY TRACT INFECTION ENTEROCOCCAL ^† 1	0/525 (0.00%)	1/521 (0.19%)
URINARY TRACT INFECTION FUNGAL ^† 1	0/525 (0.00%)	1/521 (0.19%)
UROSEPSIS ^† 1	2/525 (0.38%)	1/521 (0.19%)
VESTIBULAR NEURONITIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
VIRAL INFECTION ^† 1	1/525 (0.19%)	0/521 (0.00%)
WOUND INFECTION ^† 1	0/525 (0.00%)	1/521 (0.19%)
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE ^† 1	1/525 (0.19%)	0/521 (0.00%)
FEMORAL NECK FRACTURE ^† 1	1/525 (0.19%)	1/521 (0.19%)
FIBULA FRACTURE ^† 1	0/525 (0.00%)	1/521 (0.19%)
FOOT FRACTURE ^† 1	0/525 (0.00%)	1/521 (0.19%)
HIP FRACTURE ^† 1	0/525 (0.00%)	2/521 (0.38%)
HUMERUS FRACTURE ^† 1	2/525 (0.38%)	0/521 (0.00%)
INFUSION RELATED REACTION ^† 1	1/525 (0.19%)	1/521 (0.19%)
JOINT DISLOCATION ^† 1	1/525 (0.19%)	0/521 (0.00%)
LOWER LIMB FRACTURE ^† 1	0/525 (0.00%)	1/521 (0.19%)
MUSCLE RUPTURE ^† 1	1/525 (0.19%)	0/521 (0.00%)
PELVIC FRACTURE ^† 1	1/525 (0.19%)	0/521 (0.00%)
RIB FRACTURE ^† 1	2/525 (0.38%)	0/521 (0.00%)
SUBDURAL HAEMATOMA ^† 1	1/525 (0.19%)	0/521 (0.00%)
THORACIC VERTEBRAL FRACTURE ^† 1	1/525 (0.19%)	0/521 (0.00%)
TIBIA FRACTURE ^† 1	0/525 (0.00%)	1/521 (0.19%)
TRAUMATIC LIVER INJURY ^† 1	1/525 (0.19%)	0/521 (0.00%)
Investigations
BLOOD CREATININE INCREASED ^† 1	1/525 (0.19%)	0/521 (0.00%)
BLOOD UREA INCREASED ^† 1	1/525 (0.19%)	0/521 (0.00%)
INTERNATIONAL NORMALISED RATIO INCREASED ^† 1	0/525 (0.00%)	1/521 (0.19%)
NEUTROPHIL COUNT DECREASED ^† 1	2/525 (0.38%)	0/521 (0.00%)
PLATELET COUNT DECREASED ^† 1	0/525 (0.00%)	1/521 (0.19%)
TROPONIN INCREASED ^† 1	1/525 (0.19%)	0/521 (0.00%)
URINE OUTPUT DECREASED ^† 1	0/525 (0.00%)	1/521 (0.19%)
WHITE BLOOD CELL COUNT DECREASED ^† 1	1/525 (0.19%)	0/521 (0.00%)
Metabolism and nutrition disorders
DECREASED APPETITE ^† 1	2/525 (0.38%)	0/521 (0.00%)
DEHYDRATION ^† 1	13/525 (2.48%)	4/521 (0.77%)
DIABETES MELLITUS INADEQUATE CONTROL ^† 1	0/525 (0.00%)	1/521 (0.19%)
DIABETIC KETOACIDOSIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
GOUT ^† 1	1/525 (0.19%)	0/521 (0.00%)
HYPERGLYCAEMIA ^† 1	2/525 (0.38%)	2/521 (0.38%)
HYPOCALCAEMIA ^† 1	3/525 (0.57%)	1/521 (0.19%)
HYPOGLYCAEMIA ^† 1	0/525 (0.00%)	3/521 (0.58%)
HYPOKALAEMIA ^† 1	1/525 (0.19%)	1/521 (0.19%)
HYPONATRAEMIA ^† 1	2/525 (0.38%)	0/521 (0.00%)
HYPOPHOSPHATAEMIA ^† 1	0/525 (0.00%)	1/521 (0.19%)
HYPOVOLAEMIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
METABOLIC ACIDOSIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	2/525 (0.38%)	1/521 (0.19%)
ARTHRITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
BACK PAIN ^† 1	5/525 (0.95%)	2/521 (0.38%)
BONE PAIN ^† 1	1/525 (0.19%)	4/521 (0.77%)
BURSITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
FISTULA ^† 1	1/525 (0.19%)	0/521 (0.00%)
FLANK PAIN ^† 1	1/525 (0.19%)	0/521 (0.00%)
MUSCULAR WEAKNESS ^† 1	1/525 (0.19%)	0/521 (0.00%)
MUSCULOSKELETAL CHEST PAIN ^† 1	1/525 (0.19%)	2/521 (0.38%)
OSTEONECROSIS OF JAW ^† 1	1/525 (0.19%)	1/521 (0.19%)
PAIN IN EXTREMITY ^† 1	3/525 (0.57%)	1/521 (0.19%)
PATHOLOGICAL FRACTURE ^† 1	2/525 (0.38%)	0/521 (0.00%)
SPINAL OSTEOARTHRITIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER METASTATIC ^† 1	1/525 (0.19%)	0/521 (0.00%)
LYMPHOCYTIC LYMPHOMA ^† 1	0/525 (0.00%)	1/521 (0.19%)
METASTATIC PAIN ^† 1	0/525 (0.00%)	1/521 (0.19%)
SQUAMOUS CELL CARCINOMA OF SKIN ^† 1	0/525 (0.00%)	1/521 (0.19%)
SUPERFICIAL SPREADING MELANOMA STAGE I ^† 1	1/525 (0.19%)	0/521 (0.00%)
THYROID CANCER ^† 1	1/525 (0.19%)	0/521 (0.00%)
Nervous system disorders
CAROTID ARTERY OCCLUSION ^† 1	2/525 (0.38%)	0/521 (0.00%)
CAROTID ARTERY STENOSIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
CEREBRAL ISCHAEMIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
CEREBROVASCULAR ACCIDENT ^† 1	1/525 (0.19%)	3/521 (0.58%)
DIZZINESS ^† 1	2/525 (0.38%)	0/521 (0.00%)
DYSKINESIA ^† 1	0/525 (0.00%)	1/521 (0.19%)
HYPOAESTHESIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
ISCHAEMIC STROKE ^† 1	2/525 (0.38%)	0/521 (0.00%)
LACUNAR INFARCTION ^† 1	1/525 (0.19%)	0/521 (0.00%)
PARKINSON'S DISEASE ^† 1	1/525 (0.19%)	0/521 (0.00%)
PRESYNCOPE ^† 1	1/525 (0.19%)	0/521 (0.00%)
SCIATICA ^† 1	1/525 (0.19%)	0/521 (0.00%)
SPINAL CORD COMPRESSION ^† 1	1/525 (0.19%)	3/521 (0.58%)
SYNCOPE ^† 1	8/525 (1.52%)	4/521 (0.77%)
TRANSIENT ISCHAEMIC ATTACK ^† 1	5/525 (0.95%)	0/521 (0.00%)
TREMOR ^† 1	1/525 (0.19%)	0/521 (0.00%)
Psychiatric disorders
ANXIETY ^† 1	0/525 (0.00%)	2/521 (0.38%)
COMPLETED SUICIDE ^† 1	1/525 (0.19%)	0/521 (0.00%)
DELIRIUM ^† 1	1/525 (0.19%)	0/521 (0.00%)
MENTAL STATUS CHANGES ^† 1	0/525 (0.00%)	2/521 (0.38%)
Renal and urinary disorders
CALCULUS URETHRAL ^† 1	0/525 (0.00%)	1/521 (0.19%)
CYSTITIS HAEMORRHAGIC ^† 1	0/525 (0.00%)	1/521 (0.19%)
DYSURIA ^† 1	1/525 (0.19%)	1/521 (0.19%)
HAEMATURIA ^† 1	5/525 (0.95%)	9/521 (1.73%)
HYDRONEPHROSIS ^† 1	0/525 (0.00%)	4/521 (0.77%)
NEPHROLITHIASIS ^† 1	0/525 (0.00%)	2/521 (0.38%)
RENAL FAILURE ^† 1	0/525 (0.00%)	1/521 (0.19%)
RENAL FAILURE ACUTE ^† 1	10/525 (1.90%)	4/521 (0.77%)
RENAL INJURY ^† 1	2/525 (0.38%)	0/521 (0.00%)
URETERIC OBSTRUCTION ^† 1	0/525 (0.00%)	1/521 (0.19%)
URETHRAL OBSTRUCTION ^† 1	1/525 (0.19%)	0/521 (0.00%)
URINARY RETENTION ^† 1	3/525 (0.57%)	3/521 (0.58%)
Reproductive system and breast disorders
PELVIC PAIN ^† 1	0/525 (0.00%)	1/521 (0.19%)
PENILE HAEMORRHAGE ^† 1	0/525 (0.00%)	1/521 (0.19%)
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME ^† 1	1/525 (0.19%)	1/521 (0.19%)
ACUTE RESPIRATORY FAILURE ^† 1	1/525 (0.19%)	1/521 (0.19%)
ALVEOLITIS ALLERGIC ^† 1	1/525 (0.19%)	0/521 (0.00%)
ASTHMA ^† 1	0/525 (0.00%)	1/521 (0.19%)
BRONCHOSPASM ^† 1	1/525 (0.19%)	0/521 (0.00%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE ^† 1	0/525 (0.00%)	2/521 (0.38%)
COUGH ^† 1	2/525 (0.38%)	0/521 (0.00%)
DYSPNOEA ^† 1	13/525 (2.48%)	2/521 (0.38%)
DYSPNOEA EXERTIONAL ^† 1	1/525 (0.19%)	1/521 (0.19%)
EPISTAXIS ^† 1	1/525 (0.19%)	1/521 (0.19%)
HYPOXIA ^† 1	1/525 (0.19%)	0/521 (0.00%)
INTERSTITIAL LUNG DISEASE ^† 1	3/525 (0.57%)	0/521 (0.00%)
LUNG DISORDER ^† 1	1/525 (0.19%)	0/521 (0.00%)
PLEURAL EFFUSION ^† 1	1/525 (0.19%)	0/521 (0.00%)
PNEUMONIA ASPIRATION ^† 1	1/525 (0.19%)	0/521 (0.00%)
PNEUMONITIS ^† 1	3/525 (0.57%)	0/521 (0.00%)
PNEUMOTHORAX ^† 1	1/525 (0.19%)	1/521 (0.19%)
PULMONARY EMBOLISM ^† 1	34/525 (6.48%)	8/521 (1.54%)
PULMONARY FIBROSIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
PULMONARY HYPERTENSION ^† 1	1/525 (0.19%)	0/521 (0.00%)
RESPIRATORY FAILURE ^† 1	1/525 (0.19%)	0/521 (0.00%)
SLEEP APNOEA SYNDROME ^† 1	0/525 (0.00%)	1/521 (0.19%)
Skin and subcutaneous tissue disorders
DERMATITIS EXFOLIATIVE ^† 1	0/525 (0.00%)	1/521 (0.19%)
RASH ^† 1	1/525 (0.19%)	0/521 (0.00%)
SKIN EXFOLIATION ^† 1	0/525 (0.00%)	1/521 (0.19%)
Vascular disorders
ARTERIAL THROMBOSIS LIMB ^† 1	1/525 (0.19%)	0/521 (0.00%)
DEEP VEIN THROMBOSIS ^† 1	13/525 (2.48%)	3/521 (0.58%)
EMBOLISM ^† 1	1/525 (0.19%)	1/521 (0.19%)
HAEMATOMA ^† 1	0/525 (0.00%)	1/521 (0.19%)
HYPERTENSION ^† 1	0/525 (0.00%)	1/521 (0.19%)
HYPOTENSION ^† 1	8/525 (1.52%)	7/521 (1.34%)
JUGULAR VEIN THROMBOSIS ^† 1	0/525 (0.00%)	1/521 (0.19%)
PERIPHERAL ISCHAEMIA ^† 1	0/525 (0.00%)	2/521 (0.38%)
THROMBOPHLEBITIS ^† 1	2/525 (0.38%)	0/521 (0.00%)
VENA CAVA THROMBOSIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
VENOUS THROMBOSIS ^† 1	1/525 (0.19%)	0/521 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 14.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Docetaxel/Prednisone/Lenalidomide (DPL)	Docetaxel/ Prednisone/and Placebo (DP)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	513/525 (97.71%)	511/521 (98.08%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	154/525 (29.33%)	94/521 (18.04%)
LEUKOPENIA ^† 1	40/525 (7.62%)	34/521 (6.53%)
NEUTROPENIA ^† 1	125/525 (23.81%)	94/521 (18.04%)
THROMBOCYTOPENIA ^† 1	39/525 (7.43%)	18/521 (3.45%)
Eye disorders
LACRIMATION INCREASED ^† 1	53/525 (10.10%)	63/521 (12.09%)
Gastrointestinal disorders
ABDOMINAL PAIN ^† 1	55/525 (10.48%)	36/521 (6.91%)
CONSTIPATION ^† 1	144/525 (27.43%)	124/521 (23.80%)
DIARRHOEA ^† 1	236/525 (44.95%)	204/521 (39.16%)
DYSPEPSIA ^† 1	41/525 (7.81%)	30/521 (5.76%)
NAUSEA ^† 1	170/525 (32.38%)	153/521 (29.37%)
STOMATITIS ^† 1	50/525 (9.52%)	37/521 (7.10%)
VOMITING ^† 1	93/525 (17.71%)	63/521 (12.09%)
General disorders
ASTHENIA ^† 1	124/525 (23.62%)	117/521 (22.46%)
FATIGUE ^† 1	238/525 (45.33%)	232/521 (44.53%)
MUCOSAL INFLAMMATION ^† 1	37/525 (7.05%)	43/521 (8.25%)
OEDEMA PERIPHERAL ^† 1	146/525 (27.81%)	134/521 (25.72%)
PYREXIA ^† 1	92/525 (17.52%)	74/521 (14.20%)
Infections and infestations
NASOPHARYNGITIS ^† 1	46/525 (8.76%)	37/521 (7.10%)
URINARY TRACT INFECTION ^† 1	36/525 (6.86%)	32/521 (6.14%)
Investigations
WEIGHT DECREASED ^† 1	96/525 (18.29%)	54/521 (10.36%)
Metabolism and nutrition disorders
DECREASED APPETITE ^† 1	125/525 (23.81%)	105/521 (20.15%)
DEHYDRATION ^† 1	38/525 (7.24%)	23/521 (4.41%)
HYPERGLYCAEMIA ^† 1	35/525 (6.67%)	36/521 (6.91%)
HYPOKALAEMIA ^† 1	63/525 (12.00%)	22/521 (4.22%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	86/525 (16.38%)	73/521 (14.01%)
BACK PAIN ^† 1	88/525 (16.76%)	91/521 (17.47%)
BONE PAIN ^† 1	59/525 (11.24%)	66/521 (12.67%)
MUSCLE SPASMS ^† 1	85/525 (16.19%)	46/521 (8.83%)
MUSCULAR WEAKNESS ^† 1	25/525 (4.76%)	30/521 (5.76%)
MUSCULOSKELETAL CHEST PAIN ^† 1	31/525 (5.90%)	27/521 (5.18%)
MUSCULOSKELETAL PAIN ^† 1	39/525 (7.43%)	29/521 (5.57%)
MYALGIA ^† 1	44/525 (8.38%)	55/521 (10.56%)
PAIN IN EXTREMITY ^† 1	57/525 (10.86%)	66/521 (12.67%)
Nervous system disorders
DIZZINESS ^† 1	61/525 (11.62%)	48/521 (9.21%)
DYSGEUSIA ^† 1	113/525 (21.52%)	124/521 (23.80%)
HEADACHE ^† 1	42/525 (8.00%)	51/521 (9.79%)
PARAESTHESIA ^† 1	34/525 (6.48%)	65/521 (12.48%)
PERIPHERAL SENSORY NEUROPATHY ^† 1	99/525 (18.86%)	130/521 (24.95%)
Psychiatric disorders
INSOMNIA ^† 1	60/525 (11.43%)	64/521 (12.28%)
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	108/525 (20.57%)	76/521 (14.59%)
DYSPNOEA ^† 1	104/525 (19.81%)	88/521 (16.89%)
EPISTAXIS ^† 1	37/525 (7.05%)	52/521 (9.98%)
OROPHARYNGEAL PAIN ^† 1	30/525 (5.71%)	20/521 (3.84%)
Skin and subcutaneous tissue disorders
ALOPECIA ^† 1	223/525 (42.48%)	226/521 (43.38%)
DRY SKIN ^† 1	39/525 (7.43%)	50/521 (9.60%)
NAIL DISCOLOURATION ^† 1	22/525 (4.19%)	32/521 (6.14%)
NAIL DISORDER ^† 1	41/525 (7.81%)	59/521 (11.32%)
ONYCHOMADESIS ^† 1	14/525 (2.67%)	28/521 (5.37%)
PRURITUS ^† 1	46/525 (8.76%)	10/521 (1.92%)
RASH ^† 1	61/525 (11.62%)	59/521 (11.32%)
Vascular disorders
HYPERTENSION ^† 1	16/525 (3.05%)	33/521 (6.33%)
HYPOTENSION ^† 1	35/525 (6.67%)	24/521 (4.61%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 14.1

Limitations and Caveats

The independent DMC concluded that it was unlikely the trial would achieve its primary endpoint of improved overall survival. The sponsor agreed and the experimental lenalidomide/placebo treatment arm of the study was discontinued.

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. It has priority over subset (single center) publication, for duration of 24 months after study completion. Individual investigators have publication rights after multicenter publication is complete (or 24 months after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 60 days.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Senior Manager , Clinical Trials Disclosure
Organization:	Celgene Corporation
Phone:	1-888-260-1599
EMail:	clinicaltrialdisclosure@celgene.com

Publications of Results:

Petrylak DP, Vogelzang NJ, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, de Olza MO, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, Van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, de Wit R, Fizazi K. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015 Apr;16(4):417-25. doi: 10.1016/S1470-2045(15)70025-2. Epub 2015 Mar 3.

de Morree ES, Vogelzang NJ, Petrylak DP, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, Ochoa de Olza M, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, Li JS, de Wit R. Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study. JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000.

Other Publications:

Vogelzang NJ, Fizazi K, Burke JM, De Wit R, Bellmunt J, Hutson TE, Crane E, Berry WR, Doner K, Hainsworth JD, Wiechno PJ, Liu K, Waldman MF, Gandhi A, Barton D, Jungnelius U, Fandi A, Sternberg CN, Petrylak DP. Circulating Tumor Cells in a Phase 3 Study of Docetaxel and Prednisone with or without Lenalidomide in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Feb;71(2):168-171. doi: 10.1016/j.eururo.2016.07.051. Epub 2016 Aug 10.

Layout table for additonal information

Responsible Party:	Celgene
ClinicalTrials.gov Identifier:	NCT00988208
Other Study ID Numbers:	CC-5013-PC-002 EudraCT Number 2008-007969-23
First Submitted:	October 1, 2009
First Posted:	October 2, 2009
Results First Submitted:	June 27, 2013
Results First Posted:	September 5, 2013
Last Update Posted:	April 4, 2018

To Top