Stage III Multiple Myeloma Clinical Trial
Official title:
Randomized Phase III Trial of Consolidation Therapy With Bortezomib (Velcade®)-Lenalidomide (Revlimid®) -Dexamethasone (VRD) Versus Bortezomib (Velcade®)-Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen
Verified date | May 2015 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with bortezomib and dexamethasone to see how well they work in treating patients with multiple myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bortezomib and dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.
Status | Terminated |
Enrollment | 48 |
Est. completion date | July 2014 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Symptomatic multiple myeloma, that was symptomatic at time of initial diagnosis, but may be asymptomatic at the time of registration based on induction therapy - For the original diagnosis of myeloma, patients must have met the following criteria at one point in their disease course: bone marrow plasmacytosis (>10% plasma cells or sheets of plasma cells) or a biopsy proven plasmacytoma, and evidence of end-organ damage due to multiple myeloma including anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fractures) or renal dysfunction. - Patients may have prior exposure to bortezomib - Patients must have received a minimum of 1 cycle, maximum of 6 cycles, of a dexamethasone-based regimen; patient must not have experienced progressive disease on such therapy - The following induction regimens were considered adequate for enrollment: dexamethasone alone; vincristine, doxorubicin and dexamethasone; thalidomide and dexamethasone; lenalidomide and dexamethasone; liposomal doxorubicin and dexamethasone; the combination of any of the above agents and dexamethasone; or cyclophosphamide, lenalidomide and dexamethasone - Patients must have received the minimum cumulative dose of dexamethasone of 160 mg (sum of induction treatment) with no maximum dose specified - Patients must have been offered and refused front-line stem cell transplant OR not have been eligible for front-line stem cell transplant. - Bone marrow aspiration and/or biopsy must be obtained =< 28 days prior to randomization - All tests below must be performed =< 28 days prior to randomization: - Kappa free light chain mg/dL - Lambda free light chain mg/dL - Serum M-protein by serum protein electrophoresis (SPEP) - Urine M-protein light chain excretion by urine protein electrophoresis (UPEP) - Adequate laboratory levels within 7 days prior to randomization: hemoglobin > 7 g/dL, platelet count > 75,000 cells/mm^3, absolute neutrophil count > 1000 cells/mm^3, creatinine < 2.5 mg/dL, creatinine clearance (measured or calculated) >= 60 mL/min, direct bilirubin =< 1.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 times the upper limit of normal - Patients may be receiving bisphosphonates or erythropoietin growth factors (erythropoietic agents) for multiple myeloma - Prior palliative and/or localized radiation therapy is permitted, provided at least 14 days have passed from date of last radiation therapy to date of randomization - Patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or coumadin (patients with prior deep vein thrombosis [DVT] are eligible provided they remain on the anticoagulation regimen that was prescribed for treatment of the DVT throughout the protocol therapy) - Patients must be competent to understand the study as explained in the consent form - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 - Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking lenalidomide, and for 4 weeks after stopping treatment - Patients with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months - Age >=18 years Exclusion Criteria: - More than 8 weeks from the last day of last cycle of induction treatment - Active, uncontrolled seizure disorder; seizures in the last 6 months - Uncontrolled inter-current illness that would limit compliance with the study including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation, prior history of Stevens Johnson syndrome - Grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 - Active, uncontrolled infection - Smoldering myeloma or monoclonal gammopathy of undetermined significance - Pregnant or nursing women were not eligible. Women of child-bearing potential unwilling to use a dual method of contraception and men who were unwilling to use a condom were not eligible |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | University Of Pretoria | Pretoria | |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Bixby Medical Center | Adrian | Michigan |
United States | Hickman Cancer Center | Adrian | Michigan |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Saint Anthony's Health | Alton | Illinois |
United States | McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa |
United States | Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | The Medical Center of Aurora | Aurora | Colorado |
United States | Saint Francis Hospital and Health Centers | Beech Grove | Indiana |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
United States | Sanford Clinic North-Bemidgi | Bemidji | Minnesota |
United States | Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa |
United States | Billings Clinic | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies PC | Billings | Montana |
United States | Montana Cancer Consortium CCOP | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Toledo Clinic Cancer Centers-Bowling Green | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Montefiore Medical Center | Bronx | New York |
United States | Kings County Hospital | Brooklyn | New York |
United States | State University of New York Downstate Medical Center | Brooklyn | New York |
United States | University Hospital of Brooklyn | Brooklyn | New York |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Graham Hospital Association | Canton | Illinois |
United States | Mercy Medical Center | Canton | Ohio |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Missouri Hospital | Cape Girardeau | Missouri |
United States | Memorial Hospital | Carthage | Illinois |
United States | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | University of Missouri - Ellis Fischel | Columbia | Missouri |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | John B Amos Cancer Center | Columbus | Georgia |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Mary Imogene Bassett Hospital | Cooperstown | New York |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton CCOP | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Samaritan North Health Center | Dayton | Ohio |
United States | Veteran Affairs Medical Center | Dayton | Ohio |
United States | Oakwood Hospital | Dearborn | Michigan |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Colorado Cancer Research Program CCOP | Denver | Colorado |
United States | Exempla Saint Joseph Hospital | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | Iowa Lutheran Hospital | Des Moines | Iowa |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Iowa Oncology Research Association CCOP | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa |
United States | Mercy Capitol | Des Moines | Iowa |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Doylestown Hospital | Doylestown | Pennsylvania |
United States | Essentia Health Duluth Clinic CCOP | Duluth | Minnesota |
United States | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota |
United States | Miller-Dwan Hospital | Duluth | Minnesota |
United States | Veterans Adminstration New Jersey Health Care System | East Orange | New Jersey |
United States | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin |
United States | Sacred Heart Hospital | Eau Claire | Wisconsin |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Alexian Brothers Medical and Cancer Center | Elk Grove Village | Illinois |
United States | Union Hospital of Cecil County | Elkton MD | Maryland |
United States | Hematology Oncology Center Incorporated | Elyria | Ohio |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Green Bay Oncology - Escanaba | Escanaba | Michigan |
United States | Eureka Hospital | Eureka | Illinois |
United States | Saint Francis Hospital | Evanston | Illinois |
United States | Northbay Cancer Center | Fairfield | California |
United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
United States | Sanford Medical Center-Fargo | Fargo | North Dakota |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Fredericksburg Oncology Inc | Fredericksburg | Virginia |
United States | Fremont Memorial Hospital | Fremont | Ohio |
United States | Unity Hospital | Fridley | Minnesota |
United States | Galesburg Cottage Hospital | Galesburg | Illinois |
United States | Illinois CancerCare Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
United States | Adirondack Cancer Center | Glens Falls | New York |
United States | Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Wayne Hospital | Greenville | Ohio |
United States | Mason District Hospital | Havana | Illinois |
United States | Northern Montana Hospital | Havre | Montana |
United States | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Hopedale Medical Complex - Hospital | Hopedale | Illinois |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan |
United States | Allegiance Health | Jackson | Michigan |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Capital Regional Medical Center | Jefferson City | Missouri |
United States | UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin |
United States | Joliet Oncology-Hematology Associates Limited | Joliet | Illinois |
United States | Glacier Oncology PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Good Samaritan Hospital | Kearney | Nebraska |
United States | Columbia Basin Hematology and Oncology PLLC | Kennewick | Washington |
United States | Kettering Medical Center | Kettering | Ohio |
United States | University of Tennessee - Knoxville | Knoxville | Tennessee |
United States | Gundersen Lutheran | La Crosse | Wisconsin |
United States | Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Meeker County Memorial Hospital | Litchfield | Minnesota |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Longmont United Hospital | Longmont | Colorado |
United States | Doctors Carrol, Sheth, Raghavan | Louisville | Kentucky |
United States | McKee Medical Center | Loveland | Colorado |
United States | Mcdonough District Hospital | Macomb | Illinois |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Saint Joseph's Hospital | Marshfield | Wisconsin |
United States | Saint Luke's Hospital | Maumee | Ohio |
United States | Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio |
United States | Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee | Ohio |
United States | Orange Regional Medical Center | Middletown | New York |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Community Medical Hospital | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois |
United States | Porubcin, Michael MD (UIA Investigator) | Moline | Illinois |
United States | Sharis, Christine M MD (UIA Investigator) | Moline | Illinois |
United States | Stoffel, Thomas J MD (UIA Investigator) | Moline | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital | Monroe | Michigan |
United States | Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly | New Jersey |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Bromenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center Foundation | Normal | Illinois |
United States | Fisher-Titus Medical Center | Norwalk | Ohio |
United States | Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin |
United States | Saint Charles Hospital | Oregon | Ohio |
United States | Toledo Clinic Cancer Centers-Oregon | Oregon | Ohio |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois |
United States | Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Pekin Hospital | Pekin | Illinois |
United States | Illinois Oncology Research Association CCOP | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois Valley Hospital | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Saint Joseph Mercy Port Huron | Port Huron | Michigan |
United States | Adventist Medical Center | Portland | Oregon |
United States | Pottstown Memorial Medical Center | Pottstown | Pennsylvania |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin |
United States | Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin |
United States | Reid Hospital and Health Care Services | Richmond | Indiana |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Harbin Clinic Medical Oncology and Clinical Research | Rome | Georgia |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Center for Cancer Care and Research | Saint Louis | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Saint John's Mercy Medical Center | Saint Louis | Missouri |
United States | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri |
United States | Saint Louis-Cape Girardeau CCOP | Saint Louis | Missouri |
United States | Metro-Minnesota CCOP | Saint Louis Park | Minnesota |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | Saint Joseph's Hospital - Healtheast | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Kaiser Permanente | San Diego | California |
United States | Firelands Regional Medical Center | Sandusky | Ohio |
United States | North Coast Cancer Care | Sandusky | Ohio |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Minor and James Medical PLLC | Seattle | Washington |
United States | Swedish Medical Center-First Hill | Seattle | Washington |
United States | The Polyclinic | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Mercy Medical Center-Sioux City | Sioux City | Iowa |
United States | Saint Luke's Regional Medical Center | Sioux City | Iowa |
United States | Siouxland Hematology Oncology Associates | Sioux City | Iowa |
United States | Saint Margaret's Hospital | Spring Valley | Illinois |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield | Missouri |
United States | Stanford University Hospitals and Clinics | Stanford | California |
United States | Geisinger Medical Group | State College | Pennsylvania |
United States | Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Flower Hospital | Sylvania | Ohio |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | Mercy Saint Anne Hospital | Toledo | Ohio |
United States | Saint Vincent Mercy Medical Center | Toledo | Ohio |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio |
United States | Toledo Community Hospital Oncology Program CCOP | Toledo | Ohio |
United States | University of Toledo | Toledo | Ohio |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Carle Clinic-Urbana Main | Urbana | Illinois |
United States | Virtua West Jersey Hospital Voorhees | Voorhees | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Covenant Medical Center | Waterloo | Iowa |
United States | Marshfield Clinic-Wausau Center | Wausau | Wisconsin |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
United States | Reading Hospital | West Reading | Pennsylvania |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
United States | The Schiffler Cancer Center of Wheeling Hospital | Wheeling | West Virginia |
United States | Wheeling Hospital | Wheeling | West Virginia |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania |
United States | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Woodwinds Health Campus | Woodbury | Minnesota |
United States | Lankenau Hospital | Wynnewood | Pennsylvania |
United States | Mainline Health CCOP | Wynnewood | Pennsylvania |
United States | Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis HealthCare System | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States, South Africa,
Fonseca R, Rajkumar SV. Consolidation therapy with bortezomib/lenalidomide/ dexamethasone versus bortezomib/dexamethasone after a dexamethasone-based induction regimen in patients with multiple myeloma: a randomized phase III trial. Clin Lymphoma Myeloma. 2008 Oct;8(5):315-7. doi: 10.3816/CLM.2008.n.046. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) | Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment. The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued. |
Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years | No |
Secondary | Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR]) | CR: Patients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria: Negative immunofixation on the serum and urine at two consecutive times Disappearance of any soft tissue plasmacytomas =5% plasma cells in bone marrow If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis OR >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP) If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a >90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria |
Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years | No |
Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014. | Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years | No |
Secondary | Change in Quality of Life (QOL) From Baseline to 6 Months Post Consolidation as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) | The combined score on the FACT-Ntx TOI is of interest. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible quality of life) -100 (best possible quality of life). The primary QOL endpoint is defined as the change in the FACT-Ntx TOI score from registration to 6 months post consolidation treatment. | Baseline and 6 months post consolidation treatment | No |
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