Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Multiple Myeloma
Interventions:	Drug: Bortezomib (VELCADE); Drug: Doxorubicin hydrochloride (DOXIL/CAELYX)

  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
Velcade (Bortezomib) Monotherapy	Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Doxil/Caelyx Plus Velcade (Bortezomib)	Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.

Participant Flow:   Overall Study

	Velcade (Bortezomib) Monotherapy	Doxil/Caelyx Plus Velcade (Bortezomib)
STARTED	322	324
COMPLETED	0	0
NOT COMPLETED	322	324
Study closed by sponsor	34	37
Death	257	253
Lost to Follow-up	13	13
Withdrawal by Subject	18	21

  Baseline Characteristics

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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.
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Reporting Groups

	Description
Velcade (Bortezomib) Monotherapy	Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Doxil/Caelyx Plus Velcade (Bortezomib)	Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
Total	Total of all reporting groups

Baseline Measures

	Velcade (Bortezomib) Monotherapy	Doxil/Caelyx Plus Velcade (Bortezomib)	Total
Overall Participants Analyzed; [Units: Participants]	322	324	646
Age; [Units: Years]; Mean (Standard Deviation)	61.5 (9.56)	61.4 (9.61)	61.4 (9.58)
Gender; [Units: Participants]
Female	148	135	283
Male	174	189	363
Region of Enrollment; [Units: Participants]
ARGENTINA	6	9	15
AUSTRALIA	31	31	62
AUSTRIA	12	6	18
BELGIUM-LUXEMBURG	6	14	20
CANADA	20	23	43
CZECH REPUBLIC	14	22	36
FRANCE	21	28	49
GREAT BRITAIN	8	7	15
ISRAEL	25	21	46
ITALY	17	11	28
NETHERLANDS	29	32	61
POLAND	35	17	52
PORTUGAL	6	14	20
RUSSIA	38	34	72
SINGAPORE	3	2	5
SOUTH AFRICA	13	15	28
SPAIN	20	15	35
UNITED STATES OF AMERICA	18	23	41

  Outcome Measures

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1. Primary:

Time to Progression (TTP) [ Time Frame: Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006]) ]

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2. Secondary:

Overall Survival [ Time Frame: Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014) ]

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3. Secondary:

Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006) ]

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  Serious Adverse Events

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  Limitations and Caveats

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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
Study stopped in terms of primary endpoint based on its results at planned interim analysis (28 Apr 2006). However, Long-term follow-up for survival continued until 16 May 2014.

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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.; Restriction Description: A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact:  

Name/Title: Project Physician
Organization: Janssen R&D UK
e-mail: ClinicalTrialDisclosure@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

Sonneveld P, Hajek R, Nagler A, Spencer A, Bladé J, Robak T, Zhuang SH, Harousseau JL, Orlowski RZ; DOXIL-MMY-3001 Study Investigators. Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy. Cancer. 2008 Apr 1;112(7):1529-37. doi: 10.1002/cncr.23326.

Orlowski RZ, Nagler A, Sonneveld P, Bladé J, Hajek R, Spencer A, San Miguel J, Robak T, Dmoszynska A, Horvath N, Spicka I, Sutherland HJ, Suvorov AN, Zhuang SH, Parekh T, Xiu L, Yuan Z, Rackoff W, Harousseau JL. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007 Sep 1;25(25):3892-901. Epub 2007 Aug 6.

Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT00103506 History of Changes
Other Study ID Numbers:	CR004117; DOXILMMY3001 ( Other Identifier: Janssen Research & Development, LLC ); 2004-001842-34 ( EudraCT Number )
First Submitted:	February 9, 2005
First Posted:	February 10, 2005
Results First Submitted:	May 8, 2015
Results First Posted:	May 25, 2015
Last Update Posted:	October 19, 2015