Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
3 other identifiers
interventional
646
16 countries
103
Brief Summary
The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Dec 2004
Longer than P75 for phase_3 multiple-myeloma
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 9, 2005
CompletedFirst Posted
Study publicly available on registry
February 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
May 25, 2015
CompletedOctober 19, 2015
September 1, 2015
9.4 years
February 9, 2005
May 8, 2015
September 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression (TTP)
Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of \>=25% from lowest level in Serum M-component or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]); Urine M component or (the absolute increase must be \>=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase \>10 mg/dL. Bone marrow plasma cell percentage \>=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.
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])
Secondary Outcomes (2)
Overall Survival
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)
Number of Participants With Serious Adverse Events (SAEs)
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)
Study Arms (2)
VELCADE (bortezomib) monotherapy
ACTIVE COMPARATORBortezomib (VELCADE) 1.3 milligram per meter square (mg/m\^2) by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
DOXIL/CAELYX in combination with VELCADE (bortezomib)
EXPERIMENTALBortezomib (VELCADE) 1.3 mg/m\^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.
Interventions
1.3 mg/m\^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
mg/m\^2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.
Eligibility Criteria
You may qualify if:
- Patients with multiple myeloma who have received at least 1 prior therapy and who have either responded and later had progressive disease or have progressed during their first therapy (primary refractory) are eligible for the study
- Patients who may have received prior doxorubicin but not more than a cumulative dose of 240 milligram per meter square (mg/m\^2) doxorubicin, DOXIL, or the equivalent amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
- Must have normal cardiac function, as evidenced by a left LVEF within institutional normal limits.
You may not qualify if:
- History of treatment with VELCADE or progressive disease while receiving an anthracycline-containing regimen
- No change in disease status during initial therapy
- No treatment for malignancy within past 5 yrs (other than multiple myeloma) or progressive disease while receiving anthracycline-containing regimen
- Non-secretory disease
- Myocardial infarct within past 6 months
- No major surgery in past 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (108)
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Alabaster, Alabama, United States
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Surprise, Arizona, United States
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Berkeley, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Norwalk, Connecticut, United States
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Stamford, Connecticut, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Stuart, Florida, United States
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West Palm Beach, Florida, United States
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Altanta, Georgia, United States
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Boise, Idaho, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Minneapolis, Minnesota, United States
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Hackensack, New Jersey, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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North Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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La Plata, Argentina
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Mendoza, Argentina
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Adelaide, Australia
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Darlinghurst, Australia
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Melbourne, Australia
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Perth, Australia
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Sydney, Australia
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Graz, Austria
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Innsbruck, Austria
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Salzburg, Austria
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Vienna, Austria
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Wels, Austria
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Mont-Godinne, Belgium
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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N/a N/a, Canada
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Brno, Czechia
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Olomouc, Czechia
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Praha 2 N/A, Czechia
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Angers Cedex 1 N/A, France
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Bobigny, France
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Créteil, France
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Lille Cedex N/A, France
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Nantes, France
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Pierre-Bénite, France
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Toulouse, France
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Tours, France
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Vandœuvre-lès-Nancy, France
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Haifa, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Amsterdam-Zuidoost, Netherlands
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Delft, Netherlands
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Groningen, Netherlands
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Nieuwegein, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Utrecht, Netherlands
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Bialystok, Poland
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Gdansk, Poland
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Lodz, Poland
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Lublin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Arkhangelsk, Russia
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Izhevsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Obninsk, Russia
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Saint Petersburg, Russia
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Yekaterinburg, Russia
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Singapore, Singapore
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Bloemfontein, South Africa
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Cape Town, South Africa
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Johannesburg, South Africa
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Parktown, South Africa
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Pretoria Gauteng, South Africa
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Barcelona, Spain
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Madrid, Spain
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Salamanca, Spain
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Bath, United Kingdom
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London, United Kingdom
Related Publications (3)
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.
PMID: 25261096DERIVEDSonneveld P, Hajek R, Nagler A, Spencer A, Blade 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.
PMID: 18300257DERIVEDOrlowski RZ, Nagler A, Sonneveld P, Blade 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. doi: 10.1200/JCO.2006.10.5460. Epub 2007 Aug 6.
PMID: 17679727DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Project Physician
- Organization
- Janssen R&D UK
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2005
First Posted
February 10, 2005
Study Start
December 1, 2004
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
October 19, 2015
Results First Posted
May 25, 2015
Record last verified: 2015-09