CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Multiple Myeloma
Interventions:	Drug: CC-5013 Drug: Dexamethasone

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects in the Placebo/Dex treatment group did not continue participation beyond the period "Up To Unblinding (07 Jun 2005"). Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)".

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)". Data for the period "Extended Follow-up Cutoff (23 Jul 2008)" subsumes data for the period "Up To Unblinding (07 Jun 2005)".

Reporting Groups

	Description
CC-5013/Dex	CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo/Dex	Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

Participant Flow for 3 periods

Period 1: Up to Unblinding (07 Jun 2005)

	CC-5013/Dex	Placebo/Dex
STARTED	177	176
COMPLETED	64	13
NOT COMPLETED	113	163
Adverse Event	35	18
Progression of disease	57	124
Lack of Efficacy	3	5
Withdrawal by Subject	8	8
Death	2	1
Not specified	8	7

Period 2: Extended Follow-up Cutoff (23 Jul 2008)

	CC-5013/Dex	Placebo/Dex
STARTED	177	0
COMPLETED	6	0
NOT COMPLETED	171	0
Adverse Event	44	0
Progression of disease	87	0
Lack of Efficacy	3	0
Withdrawal by Subject	11	0
Death	5	0
Not specified	21	0

Period 3: Final Follow-up

	CC-5013/Dex	Placebo/Dex
STARTED	6	0
COMPLETED	0	0
NOT COMPLETED	6	0
Transferred into expanded access study.	3	0
Transferred into RevAssist Program	2	0
Adverse Event	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
CC-5013/Dex	CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo/Dex	Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

Baseline Measures

	CC-5013/Dex	Placebo/Dex	Total
Number of Participants [units: participants]	177	176	353
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	94	103	197
>=65 years	83	73	156
Age [units: years] Mean ± Standard Deviation	63.3 ± 9.84	62.5 ± 9.81	62.9 ± 9.81
Gender [units: participants]
Female	71	72	143
Male	106	104	210
Region of Enrollment [units: participants]
United States	142	150	292
Canada	35	26	61

Outcome Measures

Show All Outcome Measures

1. Primary:

Time to Tumor Progression (TTP) [ Time Frame: 60 weeks (median Time To Progression of CC-5013/Dex treatment group) ]

Show Outcome Measure 1

2. Secondary:

Overall Survival [ Time Frame: 170 weeks (median overall survival of CC-5013/Dex treatment group) ]

Show Outcome Measure 2

3. Secondary:

Myeloma Response [ Time Frame: Up to Unblinding (07 Jun 2005) ]

Show Outcome Measure 3

4. Secondary:

Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.) [ Time Frame: 30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group) ]

Show Outcome Measure 4

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigator shall have the right to publish and/or present the clinical data generated from the study provided that such Investigator shall furnish sponsor with a copy of the proposed publication or presentation at least 60 days in advance of submission, delete any confidential information, and delay submission for up to 90 days to permit the preparation and filing of appropriate intellectual property applications.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Analyses for efficacy had data cutoff dates of 07 Jun 2005 and a data cutoff date of 23 Jul 2008 for overall survival. Only safety data were collected for 6 subjects ongoing beyond the 23 Jul 2008 data cutoff date.

Results Point of Contact:

Name/Title: Robert Knight, M.D.
Organization: Celgene Corporation
phone: 908-673-9749
e-mail: rknight@celgene.com

No publications provided by Celgene Corporation

Publications automatically indexed to this study:

San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb 1;11(1):38-43.

Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. Epub 2009 Nov 9.

Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. Epub 2008 Sep 17.

Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42.

Responsible Party:	Robert Knight MD - Vice President, Oncology, Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00056160 History of Changes
Other Study ID Numbers:	CC-5013-MM-009
Study First Received:	March 6, 2003
Results First Received:	December 24, 2009
Last Updated:	March 10, 2010
Health Authority:	United States: Food and Drug Administration