Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma
7 other identifiers
interventional
55
1 country
25
Brief Summary
This phase II trial studies the side effects and how well bortezomib and pegylated liposomal doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing symptoms and have not received prior treatment. Bortezomib and pegylated liposomal doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2004
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2004
CompletedFirst Submitted
Initial submission to the registry
August 4, 2004
CompletedFirst Posted
Study publicly available on registry
August 5, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2008
CompletedSeptember 23, 2019
September 1, 2019
2.4 years
August 4, 2004
September 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
CR+nCR rate
Will be estimated with an exact 90% confidence interval.
After 18 weeks (6 courses of treatment)
Secondary Outcomes (6)
CR+nCR+PR rate
After 18 weeks (6 courses of treatment)
Maximal response rate
After 18 weeks (6 courses of treatment)
Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Up to 5 years
Progression-free survival
From on-study date to the date of progression or death, whichever comes first, assessed up to 5 years
Overall survival
From on-study date to the date of death, assessed up to 5 years
- +1 more secondary outcomes
Study Arms (1)
Treatment (bortezomib and pegylated liposomal doxorubicin)
EXPERIMENTALPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Given IV
Eligibility Criteria
You may qualify if:
- Patients must have a histologically confirmed diagnosis of symptomatic multiple myeloma with evaluable disease parameters
- A diagnosis of symptomatic multiple myeloma requires:
- A monoclonal serum and/or urine protein
- Clonal bone marrow plasmacytosis, or a histologically confirmed plasmacytoma
- Related organ or tissue impairment, consisting of:
- Hypercalcemia (serum calcium \> 0.25 mmol/l above the upper limit of normal, or \> 2.75 mmol/l \[i.e. \> 11.5 mg/dl\]) AND/OR
- Renal insufficiency (serum creatinine \> 173 mmol/l \[i.e., \> 2 mg/dL\]); (please note that serum creatinine may not be \>= 2.5 mg/dL) AND/OR
- Anemia (hemoglobin 2 g/dl below the lower limit of normal, or hemoglobin \< 10 g/dl) AND/OR
- Bony lesions (lytic bony lesions, or osteoporosis with compression fractures) AND/OR
- Other findings, such as symptomatic hyperviscosity, amyloidosis, or recurring bacterial infections (\> 2 episodes in 12 months)
- Patients may not have undergone any prior therapy, with the following exceptions:
- Prior plasmapheresis with plasma exchange (PLEX) for a hyperviscosity syndrome is allowed, providing the patient has no current evidence of hyperviscosity and has not required PLEX for at least one week prior to initiation of therapy
- Prior radiation therapy to areas of spinal cord compression by plasmacytomas, painful lesions due to bony involvement, or other myeloma-related indications, is allowed provided that radiation will have been completed 3 weeks before initiation of therapy
- Prior surgical intervention, such as for bony fractures or other myeloma-related complications, is allowed provided that this will have been completed 3 weeks before the initiation of therapy, and patients have recovered from surgery
- Prior therapy with corticosteroids for indications other than multiple myeloma is allowed, provided such therapy has been discontinued at least two weeks prior to study entry, and at least two weeks before their baseline disease evaluation
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Frisbie Hospital
Rochester, New Hampshire, 03867, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Lenoir Memorial Hospital
Kinston, North Carolina, 28501, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Z Orlowski
Alliance for Clinical Trials in Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2004
First Posted
August 5, 2004
Study Start
June 15, 2004
Primary Completion
October 31, 2006
Study Completion
January 8, 2008
Last Updated
September 23, 2019
Record last verified: 2019-09