Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
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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: NCT00103506 |
Recruitment Status :
Completed
First Posted : February 10, 2005
Results First Posted : May 25, 2015
Last Update Posted : October 19, 2015
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Study Type | Interventional |
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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) |
Enrollment | 646 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Velcade (Bortezomib) Monotherapy | Doxil/Caelyx Plus Velcade (Bortezomib) |
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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. | 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. |
Period Title: Overall Study | ||
Started | 322 | 324 |
Completed | 0 | 0 |
Not Completed | 322 | 324 |
Reason Not Completed | ||
Study closed by sponsor | 34 | 37 |
Death | 257 | 253 |
Lost to Follow-up | 13 | 13 |
Withdrawal by Subject | 18 | 21 |
Baseline Characteristics
Arm/Group Title | Velcade (Bortezomib) Monotherapy | Doxil/Caelyx Plus Velcade (Bortezomib) | Total | |
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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. | 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 of all reporting groups | |
Overall Number of Baseline Participants | 322 | 324 | 646 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 322 participants | 324 participants | 646 participants | |
61.5 (9.56) | 61.4 (9.61) | 61.4 (9.58) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 322 participants | 324 participants | 646 participants | |
Female |
148 46.0%
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135 41.7%
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283 43.8%
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Male |
174 54.0%
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189 58.3%
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363 56.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 322 participants | 324 participants | 646 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
Adverse Events
Limitations and Caveats
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.
More Information
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.
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 |
EMail: | ClinicalTrialDisclosure@its.jnj.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT00103506 |
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 |