Thalidomide + Dexamethasone Versus DOXIL (Doxorubicin HCl Liposome Injection) + Thalidomide + Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

This study is ongoing, but not recruiting participants.

Study NCT00097981 Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

First Received: December 1, 2004 Last Updated: September 25, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Conditions:	Cancer Multiple Myeloma
Interventions:	Drug: Thalidomide and dexamethasone Drug: Thalidomide and dexamethasone plus DOXIL

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Thalidomide + Dexamethasone	No text entered.
DOXIL + Thalidomide + Dexamethasone	No text entered.

Participant Flow: Overall Study

	Thalidomide + Dexamethasone	DOXIL + Thalidomide + Dexamethasone
STARTED	113^[1]	112^[2]
COMPLETED	7^[3]	12^[4]
NOT COMPLETED	106	100
Adverse Event	32	44
Withdrawal by Subject	12	9
Protocol Violation	5	2
Death	2	4
Physician Decision	7	1
Transplant planned	28	27
Disease Progression	8	2
Sponsor Request - Study Termination	12	11

[1]	Enrollment at randomization
[2]	Enrollment at randomization
[3]	Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.
[4]	Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.

Baseline Characteristics

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Reporting Groups

	Description
Thalidomide + Dexamethasone	No text entered.
DOXIL + Thalidomide + Dexamethasone	No text entered.

Baseline Measures

	Thalidomide + Dexamethasone	DOXIL + Thalidomide + Dexamethasone	Total
Number of Participants [units: participants]	113	112	225
Age [units: years] Mean ± Standard Deviation	60 ± 10	61 ± 11	60 ± 11
Gender [units: participants]
Female	51	44	95
Male	62	68	130

Outcome Measures

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1. Primary:

Complete Response Rate Defined as the Number of Participants Who Achieve a Complete Response [ Cycle 2 until 28 days following completion of treatment ]

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Measure Type	Primary
Measure Title	Complete Response Rate Defined as the Number of Participants Who Achieve a Complete Response
Measure Description	This is assessed at the beginning of every treatment cycle prior to treatment starting at Cycle 2. Complete response must be maintained for at least 6 weeks.
Time Frame	Cycle 2 until 28 days following completion of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat (ITT)

Reporting Groups

	Description
Thalidomide + Dexamethasone	No text entered.
DOXIL + Thalidomide + Dexamethasone	No text entered.

Measured Values

	Thalidomide + Dexamethasone	DOXIL + Thalidomide + Dexamethasone
Number of Participants Analyzed [units: participants]	113	112
Complete Response Rate Defined as the Number of Participants Who Achieve a Complete Response [units: Participants]	5	8

Statistical Analysis 1 for Complete Response Rate Defined as the Number of Participants Who Achieve a Complete Response

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.49

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by International Prognostic Index (IPI) stage 1,2 and 3
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2. Secondary:

Overall Response [ Cycle 2 until 28 days following completion of treatment ]

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3. Secondary:

Time to 1st Response [ Cycle 2 until 28 days following completion of treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

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
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Results Point of Contact:

Name/Title: Medical Director
Organization: Centocor Ortho Biotech Services, L.L.C.
e-mail: clowery1@its.jnj.com

No publications provided

Responsible Party:	Ortho Biotech Products, L.P. ( Vice President Medical Affairs Oncology/Nephrology )
Study ID Numbers:	CR004579
Study First Received:	December 1, 2004
Results First Received:	October 2, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00097981 History of Changes
Health Authority:	United States: Food and Drug Administration