DS Stage II Plasma Cell Myeloma Clinical Trial
Official title:
Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma
Verified date | September 2019 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | January 8, 2008 |
Est. primary completion date | October 31, 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Vermont and State Agricultural College | Burlington | Vermont |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina |
United States | Jupiter Medical Center | Jupiter | Florida |
United States | Lenoir Memorial Hospital | Kinston | North Carolina |
United States | Mount Sinai Medical Center | Miami Beach | Florida |
United States | Minneapolis VA Medical Center | Minneapolis | Minnesota |
United States | Palo Alto Medical Foundation-Camino Division | Mountain View | California |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas |
United States | Frisbie Hospital | Rochester | New Hampshire |
United States | Center for Cancer Care and Research | Saint Louis | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CR+nCR rate | Will be estimated with an exact 90% confidence interval. | After 18 weeks (6 courses of treatment) | |
Secondary | CR+nCR+PR rate | Will be estimated with an exact 90% confidence interval. | After 18 weeks (6 courses of treatment) | |
Secondary | Maximal response rate | After 18 weeks (6 courses of treatment) | ||
Secondary | Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Toxicities will be tabulated by type and grade. | Up to 5 years | |
Secondary | Progression-free survival | Will be estimated using the Kaplan-Meier method. | From on-study date to the date of progression or death, whichever comes first, assessed up to 5 years | |
Secondary | Overall survival | Will be estimated using the Kaplan-Meier method. | From on-study date to the date of death, assessed up to 5 years | |
Secondary | Changes in IL-6 and MIP-1 | The association of response with pre-treatment characteristics such as cytogenetics and fluorescence in situ hybridization and with early changes in IL-6 and MIP-1 will be described by reporting response rates (and their confidence intervals) according to subgroup (e.g., response rates by age group; response rates by large/small change in IL-6 level). | Baseline to up to day 2 of course 1 |
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---|---|---|---|
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