Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
NCT ID: NCT00088855
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2004-06-15
2008-01-08
Brief Summary
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Detailed Description
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I. To evaluate the complete response (CR) + near-complete response (nCR) rate of the bortezomib/pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) regimen in patients with previously untreated, symptomatic multiple myeloma.
II. To evaluate the toxicity of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate, including patients with CR, nCR, and partial response (PR), of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
II. To evaluate the impact of therapy with the bortezomib/pegylated liposomal doxorubicin regimen on the ability to collect peripheral blood stem cells in those patients going on to subsequent autologous stem cell transplantation.
III. To evaluate the time to progression (TTP) in all patients receiving bortezomib/pegylated liposomal doxorubicin therapy, both those who go on to autologous stem cell transplantation and those who do not go on to transplantation.
IV. To evaluate the value of early changes in levels of serum interleukin 6 (IL-6) and macrophage inflammatory protein 1 alpha (MIP-1α) as predictors of response to bortezomib/pegylated liposomal doxorubicin.
V. To correlate pre-treatment clinical and biological characteristics with response to therapy and toxicity.
OUTLINE:
Patients receive bortezomib intravenously (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.
After completion of study treatment, patients are followed up every 6 weeks for 2 years and then every 6 months for 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (bortezomib and pegylated liposomal doxorubicin)
Patients 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.
Bortezomib
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Interventions
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Bortezomib
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prior supportive therapy with bisphosphonates or erythropoietin is allowed
* Inclusion of females of childbearing potential requires a negative pregnancy test
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Patients may not have a prior history of a hypersensitivity reaction to pegylated liposomal doxorubicin or doxorubicin, bortezomib or other boronic acid-based compounds
* Patients with a history of reactions to liposomal drug formulations other than pegylated liposomal doxorubicin will be evaluated individually, and if their reactions were felt to have been due to the liposomal component itself, as opposed to the encapsulated agent, they will be excluded at the discretion of the investigators
* Patients who are known to be human immunodeficiency virus (HIV)-seropositive and are taking anti-retrovirals may not participate in this study; patients who are HIV-seropositive and not on anti-retroviral therapy, and who otherwise meet the organ function criteria, will be eligible for the study
* Patients who are known to have active hepatitis A, B, or C viral infection may not participate in this study
* No electrocardiogram (EKG) evidence of acute ischemia
* No EKG evidence of medically significant conduction system abnormalities
* No history of myocardial infarction within the last 6 months
* Left ventricular ejection fraction (LVEF) must be \>= 45% by either echocardiography or radionuclide-based multiple gated acquisition (radionuclide ventriculography \[RNV\] or multiple gate acquisition scan \[MUGA\])
* No class 3 or class 4 New York Heart Association congestive heart failure
* Creatinine \< 2.5 mg/dL
* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 times the upper limit of the institutional normal value
* Total bilirubin =\< 1.2 times the upper limit of the institutional normal value
* Absolute neutrophil count (ANC) \>= 1,000/ul
* Platelets \>= 100,000/ul
* Hemoglobin \>= 8 g/dl (transfusion- and/or growth factor-dependent patients are not excluded if the above parameters can be achieved with such support)
* For those patients receiving warfarin (Coumadin), unfractionated heparin, or low-molecular weight heparin therapy, the applicable coagulation parameter that is being monitored must be within the accepted therapeutic ranges for those indications
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Robert Z Orlowski
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
Frisbie Hospital
Rochester, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Lenoir Memorial Hospital
Kinston, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Danville Regional Medical Center
Danville, Virginia, United States
Countries
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Other Identifiers
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NCI-2014-01607
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02810
Identifier Type: -
Identifier Source: secondary_id
CDR377483
Identifier Type: -
Identifier Source: secondary_id
CALGB 10301
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-10301
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2014-01607
Identifier Type: -
Identifier Source: org_study_id
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