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Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Light Chain Deposition Disease, Smoldering Multiple Myeloma

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Trial Information

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma


PRIMARY OBJECTIVES:

I. Study the risk of grade 3-4 non-hematologic adverse events in patients with asymptomatic
high-risk smoldering multiple myeloma treated with lenalidomide. (Phase II) II. Compare the
progression-free survival (PFS) of patients with asymptomatic high-risk smoldering multiple
myeloma treated with lenalidomide versus observation alone. (Phase III)

SECONDARY OBJECTIVES:

I. Assess the response of patients treated with lenalidomide. (Phase II) II. Determine and
compare the response rate, time to progression, 1-year PFS probability, and the overall
survival of patients treated with lenalidomide versus observation alone. (Phase III) III.
Estimate the incidence of adverse events of these regimens in these patients. (Phase III)

TERTIARY OBJECTIVES:

I. Describe the cohort in terms of GEP and cytogenetic risk classification and evaluate
baseline immune and MRI parameters. (Phase II) II. Evaluate the impact of therapy within
GEP-defined risk groups and GEP as a prognostic marker. (Phase III) III. Study the effects
of lenalidomide on laboratory markers of immune function. (Phase III) IV. Study the
prognostic value of MRI-detected asymptomatic bone disease on clinical outcome. (Phase III
V. Evaluate the prognostic effect of baseline high-risk cytogenetic abnormalities on
clinical outcome. (Phase III)

QUATERNARY OBJECTIVES:

I. To compare QOL change between treatment and observation arms based on the functional
(FWB) and physical (PWB) well-being components of the FACT-General (G) patient-reported
outcome (PRO) measure from registration (prior to initiation of treatment) up to cycle 24.

II. To examine the impact of differential treatment response (PFS), if observed, on QOL
based on the FACT FWB+PWB up to cycle 48.

III. To obtain prospective data on Myeloma specific QOL attributes, utilizing and evaluating
the Multiple Myeloma Subscale (MMS).

OUTLINE: This is a multicenter study.

PHASE II: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment
repeats every 28 days for 6 courses in the absence of disease progression or unacceptable
toxicity.

PHASE III: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive standard of care and undergo observation in the absence of disease
progression.

Peripheral blood, bone marrow aspirate, and bone marrow core biopsy samples are collected
for gene expression profiling, immune function, and cytogenetic abnormalities. Patients
complete the Functional Assessment of Cancer Therapy (FACT) Physical Well-Being (PWB), and
FACT Functional Well-Being (FWB) questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 10 years.


Inclusion Criteria:



- Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma
(SMM) within the past 12 months, as confirmed by both of the following:

- Bone marrow plasmacytosis with >= 10% plasma cells or sheet of plasma cells
which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks
prior to randomization

- Abnormal serum free-light chain (FLC) ratio (< 0.125 or > 8.0) by serum FLC
assay; FLC assay must be performed within 28 days of randomization

- Measurable monoclonal protein in the serum >= 1.0 g/dL or urine >= 200 mg/24 hrs

- No lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count (ANC) > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin > 11 g/dL

- Creatinine clearance > 30 mL/min

- Bilirubin < 1.5 mg/dL

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times upper
limit of normal

- More than 6 months since active, uncontrolled seizure disorder

- Willing to take some form of anti-coagulation as prophylaxis if there is a history of
or concurrent deep vein thrombosis or pulmonary embolism

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception for ≥ 28 days before,
during, and ≥ 28 days after completion of study therapy

- Prior malignancy allowed provided treatment of curative intent was delivered and
disease-free for time period considered appropriate for the specific cancer

- Human immunodeficiency virus (HIV)-positive patients allowed provided the following
criteria are met:

- CD4 cell count >= 350/mm³

- No history of acquired immunodeficiency syndrome (AIDS)-related illness

- No uncontrolled intercurrent illness including any of the following:

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina

- Uncontrolled cardiac arrhythmia

- Uncontrolled psychiatric illness or social situation that would limit compliance
with the study

- Prior Stevens Johnson Syndrome

- No peripheral neuropathy >= grade 2

- No active uncontrolled infection

- No New York Heart Association (NYHA) class III or IV heart failure

- No prior or concurrent systemic therapy or radiotherapy for MM

- No prior or concurrent erythropoietin

- No prior glucocorticosteroid for MM

- Prior systemic glucocorticosteroid for non-malignant disorders allowed
(prednisone equivalent ≤ 10 mg/day)

- Prior or concurrent topical or localized glucocorticosteroid to treat
non-malignant comorbid disorders allowed

- No concurrent bisphosphonates

- Prior bisphosphonates or once-a-year intravenous bisphosphonate for osteoporosis
allowed

- No concurrent zidovudine or stavudine for HIV-positive patients

- No concurrent chemotherapy including cyclophosphamide and stem cell mobilization

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Grade 3 or higher non-hematologic toxicity based on AdEERS expedited reporting (Phase II)

Outcome Description:

The difference in rates of all Grade 3 or higher toxicities will be evaluated for all randomized patients using the Fisher's Exact Test.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Sagar Lonial

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02057

NCT ID:

NCT01169337

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Light Chain Deposition Disease
  • Smoldering Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Albert Einstein College of MedicineBronx, New York  10461
Mayo ClinicRochester, Minnesota  55905
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Hurley Medical CenterFlint, Michigan  48503
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
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Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Marshfield ClinicMarshfield, Wisconsin  54449
Methodist Medical Center of IllinoisPeoria, Illinois  61636
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Montefiore Medical CenterBronx, New York  10467-2490
North Colorado Medical CenterGreeley, Colorado  80631
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Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
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Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Welch Cancer CenterSheridan, Wyoming  82801
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
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Memorial HospitalCarthage, Illinois  62321
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Creighton University Medical CenterOmaha, Nebraska  68131-2197
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Grandview HospitalDayton, Ohio  45405
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Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
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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
Rice Memorial HospitalWillmar, Minnesota  56201
Geisinger Medical GroupState College, Pennsylvania  16801
Swedish American HospitalRockford, Illinois  61104
Miami Valley HospitalDayton, Ohio  45409
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Lawrence Memorial HospitalLawrence, Kansas  66044
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Northern Montana HospitalHavre, Montana  59501
Mary Rutan HospitalBellefontaine, Ohio  43311
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Knox Community HospitalMount Vernon, Ohio  43050
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Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
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Longmont United HospitalLongmont, Colorado  80501
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Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Manchester Memorial HospitalManchester, Connecticut  06040-4188
Memorial Medical CenterSpringfield, Illinois  62781
Wellmont Holston Valley Hospital and Medical CenterKingsport, Tennessee  37662
Northwest Cancer SpecialistsVancouver, Washington  98664
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Holy Cross HospitalFort Lauderdale, Florida  33308
Case Western Reserve UniversityCleveland, Ohio  44106
Emory UniversityAtlanta, Georgia  30322
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Licking Memorial HospitalNewark, Ohio  43055-2899
Providence Portland Medical CenterPortland, Oregon  97213-3635
Mid Dakota ClinicBismarck, North Dakota  58501
Columbus CCOPColumbus, Ohio  43206
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
University of Texas Southwestern Medical CenterDallas, Texas  
Montana Cancer Consortium CCOPBillings, Montana  59101
Alegent Health Immanuel Medical CenterOmaha, Nebraska  68122
Alegent Health Bergan Mercy Medical CenterOmaha, Nebraska  68124
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Providence HospitalSouthfield, Michigan  48075
Cancer Centers of the Carolinas - EasleyEasley, South Carolina  29640
Lakeview HospitalStillwater, Minnesota  55082
Decatur Memorial HospitalDecatur, Illinois  62526
Lankenau HospitalWynnewood, Pennsylvania  19096
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Florida HospitalOrlando, Florida  32803
Southeast Cancer CenterCape Girardeau, Missouri  63703
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Parker Adventist HospitalParker, Colorado  80138
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Northside HospitalAtlanta, Georgia  30342
Palo Alto Medical Foundation-Camino DivisionMountain View, California  94040
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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
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
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Danbury HospitalDanbury, Connecticut  06810
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The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Phoebe Putney Memorial HospitalAlbany, Georgia  31703
Veterans Administration Medical CenterDecatur, Georgia  30033
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Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
McFarland ClinicAmes, Iowa  50010
Hematology Oncology Associates-Quad CitiesBettendorf, Iowa  52722
Genesis Medical Center - East CampusDavenport, Iowa  52803
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Ochsner Clinic Foundation-Baton RougeBaton Rouge, Louisiana  70809
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
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
Miller-Dwan HospitalDuluth, 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
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Kansas City Veterans Affairs Medical CenterKansas City, Missouri  64128
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
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
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Lincoln Medical Education Foundation Cancer Resource CenterLincoln, Nebraska  68510
Missouri Valley Cancer Consortium CCOPOmaha, Nebraska  68106
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
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Kinston Medical Specialists PAKinston, North Carolina  28501
Saint Alexius Medical CenterBismarck, North Dakota  58501
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
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Saint Rita's Medical CenterLima, Ohio  45801
Marietta Memorial HospitalMarietta, Ohio  45750
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Providence Saint Vincent Medical CenterPortland, Oregon  97225
Columbia River Oncology ProgramPortland, Oregon  97225
Saint Luke's HospitalBethlehem, Pennsylvania  18015
Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Greenville CCOPGreenville, South Carolina  29615
Greenville Memorial HospitalGreenville, South Carolina  29605
Conklin Regional Cancer CenterAberdeen, South Dakota  57401
Southwest VA Regional Cancer CenterNorton, Virginia  24273
Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311-6519
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
Vince Lombardi Cancer Clinic-MarinetteMarinette, Wisconsin  54143
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Oconomowoc Memorial Hospital-ProHealth Care IncOconomowoc, Wisconsin  53066-3896
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Jupiter Medical CenterJupiter, Florida  33458
Rutland Regional Medical CenterRutland, Vermont  05701
University of IllinoisChicago, Illinois  60612
Memorial Healthcare System - Joe DiMaggio Children's HospitalHollywood, Florida  33021
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Illinois CancerCare-BloomingtonBloomington%, Illinois  61701
Illinois CancerCare-CantonCanton, Illinois  61520
Illinois CancerCare-CarthageCarthage, Illinois  62321
Illinois CancerCare-EurekaEureka, Illinois  61530
Illinois CancerCare-HavanaHavana, Illinois  62644
Illinois CancerCare-Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare-MacombMacomb, Illinois  61455
Illinois CancerCare-MonmouthMonmouth, Illinois  61462
Illinois CancerCare-Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare-PekinPekin, Illinois  61603
Illinois CancerCare-PeruPeru, Illinois  61354
Illinois CancerCare-PrincetonPrinceton, Illinois  61356
Illinois CancerCare-Spring ValleySpring Valley, Illinois  61362
Central Care Cancer Center-Carrie J Babb Cancer CenterBolivar, Missouri  65613
Skaggs Cancer CenterBranson, Missouri  65616
Roper HospitalCharleston, South Carolina  29401
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Medical OncologyGreer, South Carolina  29650
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
West Virginia University CharlestonCharleston, West Virginia  25304
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
Vince Lombardi Cancer Clinic-SheboyganSheboygan, Wisconsin  53081
Marshfield Clinic Cancer Care at Saint Michael's HospitalStevens Point, Wisconsin  54481
Aurora Medical Center in SummitSummit, Wisconsin  53066
Vince Lombardi Cancer ClinicTwo Rivers, Wisconsin  54241
Ochsner North Shore Medical CenterCovington, Louisiana  70433
Capital Region Medical Center-Goldschmidt Cancer CenterJefferson City, Missouri  65109
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Susquehanna Cancer CenterWilliamsport, Pennsylvania  17701
Gundersen LutheranLa Crosse, Wisconsin  54601
Columbia Saint Mary's Water Tower Medical CommonsMilwaukee, Wisconsin  53211
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Walter Reed National Military Medical CenterBethesda, Maryland  20889
IU Health ArnettLafayette, Indiana  
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Eastern Cooperative Oncology GroupBoston, Massachusetts  02215
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Essentia Health Saint Joseph's Medical CenterBrainerd, Minnesota  56401
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
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