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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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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