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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

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


PRIMARY OBJECTIVES:

I. To compare the progression-free survival (PFS) of patients with previously treated
symptomatic multiple myeloma treated with consolidation therapy comprising bortezomib and
dexamethasone with vs without lenalidomide.

SECONDARY OBJECTIVES:

I. To determine the incremental ability of these regimens in attaining a complete response
or a very good partial response (VGPR) in these patients.

II. To compare the overall survival of patients treated with these regimens. III. To compare
the toxicity of these regimens in these patients. IV. To compare the quality of life of
these patients. V. To examine the impact of differential treatment response, if observed, on
quality of life of these patients.

VI. To obtain prospective data on multiple myeloma specific quality of life attributes.

OUTLINE: Patients are stratified according to prior induction therapy with lenalidomide and
dexamethasone (yes vs no) and whether or not they are in complete response after induction
therapy at study registration (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral lenalidomide once a day
on days 1-14, and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days
for 8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral dexamethasone once a
day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed periodically. After completion of study treatment, patients are
followed every 3 months for 2 years, every 6 months for 3 years, and then every 12 months
for 5 years.


Inclusion Criteria:



- Diagnosis of symptomatic multiple myeloma

- Must meet the following criteria at one point in the course of the disease for the
original diagnosis of myeloma:

- Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or
biopsy proven plasmacytoma

- Must have symptomatic disease that prompted the initiation of therapy (e.g.,
anemia, hypercalcemia, bone disease, or renal dysfunction)

- Must have completed a minimum of 1 and a maximum of 6 courses of a
dexamethasone-based regimen within the past 8 weeks, including any of the following:

- 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

- Cyclophosphamide, lenalidomide, and dexamethasone

- Received a minimum cumulative dose of 160 mg of dexamethasone (no maximum dose
specified)

- Must have not experienced progressive disease on the dexamethasone-based regimen

- Patients diagnosed with only smoldering myeloma or monoclonal gammopathy of
undetermined significance are not eligible

- ECOG performance status 0-2

- Hemoglobin > 7 g/dL

- Platelet count > 75,000/mm^3

- Absolute neutrophil count > 1,000/mm^3 (without the use of growth factors to increase
ANC)

- Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) ≥ 60 mL/min

- Direct bilirubin < 1.5 mg/dL

- ALT and AST < 2.5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for 4 weeks prior to,
during, and for 4 weeks after completion of study therapy

- No active uncontrolled seizure disorder

- No seizure within the past 6 months

- No concurrent uncontrolled illness that would limit compliance with the study,
including any of the following:

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina

- Uncontrolled cardiac arrhythmia

- Uncontrolled psychiatric illness or social situation

- History of Steven Johnson syndrome

- No peripheral neuropathy ≥ grade 2

- No active uncontrolled infection

- Patients with a history of prior malignancy are eligible provided there is no active
malignancy AND there is a low expectation of recurrence within 6 months

- Must be willing and able to receive prophylaxis with aspirin (325 mg/day) or
alternative prophylaxis with low molecular weight heparin or coumadin

- Patients with prior DVT are eligible provided they remain on the anticoagulation
regimen that was prescribed for treatment of the DVT throughout study therapy

- Concurrent bisphosphonates or growth factors (e.g., granulocyte and/or erythropoietic
agents) for multiple myeloma allowed

- At least 14 days since prior palliative and/or localized radiotherapy

- Prior bortezomib allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS of two consolidation regimens

Outcome Description:

PFS in each of the arms will be estimated using the method of Kaplan and Meier. PFS between the two arms will be compared using one-sided stratified log-rank test.

Outcome Time Frame:

Time from consolidation randomization until progression or death of any cause, assessed up to 10 years

Safety Issue:

No

Principal Investigator

Rafael Fonseca

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00521

NCT ID:

NCT00522392

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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Mayo ClinicRochester, Minnesota  55905
Abington Memorial HospitalAbington, Pennsylvania  19001
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Rapid City Regional HospitalRapid City, South Dakota  57709
Marshfield ClinicMarshfield, Wisconsin  54449
Stanford UniversityStanford, California  94305
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Wesley Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Great Falls ClinicGreat Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Montefiore Medical CenterBronx, New York  10467-2490
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Harborview Medical CenterSeattle, Washington  98104
Welch Cancer CenterSheridan, Wyoming  82801
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Beebe Medical CenterLewes, Delaware  19958
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Valley Cancer CenterSpring Valley, Illinois  61362
Community Cancer Center of MonroeMonroe, Michigan  48162
Saint Francis Medical CenterCape Girardeau, Missouri  63701
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Grandview HospitalDayton, Ohio  45405
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
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Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Eureka HospitalEureka, Illinois  61530
Mercy HospitalCoon Rapids, Minnesota  55433
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Bixby Medical CenterAdrian, Michigan  49221
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Mary Imogene Bassett HospitalCooperstown, New York  13326
Saint Luke's HospitalMaumee, Ohio  43537
Lancaster General HospitalLancaster, Pennsylvania  17604-3555
Geisinger Medical GroupState College, Pennsylvania  16801
Franciscan Skemp HealthcareLa Crosse, Wisconsin  54601-4796
Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Miami Valley HospitalDayton, Ohio  45409
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Mary Rutan HospitalBellefontaine, Ohio  43311
Wayne HospitalGreenville, Ohio  45331
Fisher-Titus Medical CenterNorwalk, Ohio  44857
Clinton Memorial HospitalWilmington, Ohio  45177
Adventist Medical CenterPortland, Oregon  97216
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
UW Cancer Center Johnson CreekJohnson Creek, Wisconsin  53038
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Longmont United HospitalLongmont, Colorado  80501
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Greene Memorial HospitalXenia, Ohio  45385
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Memorial Medical CenterSpringfield, Illinois  62781
Doylestown HospitalDoylestown, Pennsylvania  18901
McLeod Regional Medical CenterFlorence, South Carolina  29501
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Woodwinds Health CampusWoodbury, Minnesota  55125
Hennepin County Medical CenterMinneapolis, Minnesota  
Case Western Reserve UniversityCleveland, Ohio  44106
Toledo ClinicOregon, Ohio  43616
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
Kaiser PermanenteSacramento, California  
Montana Cancer Consortium CCOPBillings, Montana  59101
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
University of New MexicoAlbuquerque, New Mexico  87131
Decatur Memorial HospitalDecatur, Illinois  62526
Lankenau HospitalWynnewood, Pennsylvania  19096
Montana Cancer SpecialistsMissoula, Montana  59807-7877
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Northbay Cancer CenterFairfield, California  94533
The Medical Center of AuroraAurora, Colorado  80012
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Saint Anthony Central HospitalDenver, Colorado  80204
Exempla Saint Joseph HospitalDenver, Colorado  80218
Colorado Cancer Research Program CCOPDenver, Colorado  80224-2522
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Saint Mary Corwin Medical CenterPueblo, Colorado  81004
John B Amos Cancer CenterColumbus, Georgia  31904
Saint Anthony's HealthAlton, Illinois  62002
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Saint Francis HospitalEvanston, Illinois  60202
Intercommunity Cancer CenterGalesburg, Illinois  61401
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
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Stoffel, Thomas J MD (UIA Investigator)Moline, Illinois  61265
Garneau, Stewart C MD (UIA Investigator)Moline, Illinois  61265
Sharis, Christine M MD (UIA Investigator)Moline, Illinois  61265
Porubcin, Michael MD (UIA Investigator)Moline, Illinois  61265
Good Samaritan Regional Medical CenterMt. Vernon, Illinois  62864
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Saint Margaret's HospitalSpring Valley, Illinois  61362
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
McFarland ClinicAmes, Iowa  50010
Constantinou, Costas L MD (UIA Investigator)Bettendorf, Iowa  52722
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Siouxland Hematology - Oncology AssociatesSioux City, Iowa  51101
Covenant Medical CenterWaterloo, Iowa  50702
Hickman Cancer CenterAdrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial HospitalMonroe, Michigan  48162
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Merit Care Clinic BemidjiBemidji, Minnesota  56601
Saint Mary's Medical CenterDuluth, Minnesota  55805
Miller-Dwan HospitalDuluth, Minnesota  55805
Duluth Clinic CCOPDuluth, Minnesota  55805
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Saint Joseph's Hospital - HealtheastSaint Paul, Minnesota  55102
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Southeast Missouri HospitalCape Girardeau, Missouri  63701
Saint Louis-Cape Girardeau CCOPSaint Louis, Missouri  63141
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
Saint Louis Cancer and Breast InstituteSaint Louis, Missouri  63109
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Good Samaritan HospitalKearney, Nebraska  68847
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Veterans Adminstration New Jersey Health Care SystemEast Orange, New Jersey  07018-1095
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington CountyMount Holly, New Jersey  08060
Virtua West Jersey Hospital VoorheesVoorhees, New Jersey  08043
Adirondack Cancer CenterGlens Falls, New York  12801
Orange Regional Medical CenterMiddletown, New York  10940
Meritcare HospitalFargo, North Dakota  58122
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Veteran Affairs Medical CenterDayton, Ohio  45428
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Bayview Oncology AssociatesOregon, Ohio  43616
Saint Charles HospitalOregon, Ohio  43616
North Coast Cancer CareSandusky, Ohio  44870
Flower Memorial HospitalSylvania, Ohio  43560
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
The Toledo HospitalToledo, Ohio  43606
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Geisinger South Wilkes Barre-Hazelton Cancer CenterHazleton, Pennsylvania  18201
Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Mainline Health CCOPWynnewood, Pennsylvania  19096
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Saint Joseph HospitalBellingham, Washington  98225
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Wheeling HospitalWheeling, West Virginia  26003
Sacred Heart HospitalEau Claire, Wisconsin  54701
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Bay Area Medical CenterMarinette, Wisconsin  54143
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
Saint Michael's HospitalStevens Point, Wisconsin  54481
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
Marshfield Clinic-Wausau CenterWausau, Wisconsin  54401
Christiana Healthcare Services - Christian HospitalNewark, Delaware  19718
Harbin Clinic Medical Oncology and Clinical ResearchRome, Georgia  30165
University of Missouri - Ellis FischelColumbia, Missouri  65203
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
State University of New York Downstate Medical CenterBrooklyn, New York  11203
Capital Regional Medical CenterJefferson City, Missouri  65101
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Kings County HospitalBrooklyn, New York  11203
Gundersen LutheranLa Crosse, Wisconsin  54601
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