Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma

Completed · Phase 2

Conditions studied: DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma

In brief

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.

Key facts

Study ID

NCT00088855

Run by

National Cancer Institute (NCI)

People needed

55

Starts

2004-06-15

Expected to finish

2008-01-08

Last updated by the study team

2019-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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