Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma
Smoldering Plasma Cell Myeloma
About this trial
This is an interventional treatment trial for Smoldering Plasma Cell Myeloma
Eligibility Criteria
Inclusion Criteria:
Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:
- Abnormal serum free light chain ratio of involved to uninvolved >20, but less than 100 if the involved FLC is >= 10 mg/dL by serum free light chain (FLC) assay
- Serum M-protein level >= 2 gm/dL
- Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
- >20% plasma cells on biopsy or aspirate
- Bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
- >= 1 g/dL on serum protein electrophoresis (within 28 days prior to randomization).
>= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (within 28 days prior to randomization).
- NOTE: In the rare situation where the serum protein electrophoresis (SPEP) is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted.
SPEP, urine protein electrophoresis (UPEP), and serum FLC are required to be performed within 28 days prior to randomization.
- NOTE: UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hour (hr), and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response.
- Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above upper limit of normal [ULN]).
- Hemoglobin >= 11 g/dL (within 28 days prior to randomization).
- Platelet count >= 100,000 cells/mm^3 (within 28 days prior to randomization).
- Absolute neutrophil count >= 1500 cells/mm^3 (within 28 days prior to randomization).
- Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization).
- Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization).
- 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 (within 28 days prior to randomization).
- Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have contraindication to deep vein thrombosis (DVT) prophylaxis/aspirin.
- Patients must not have more than one focal marrow lesion on magnetic resonance imaging (MRI) of either pelvis or spine. Patients with indwelling pacemakers and/or ICD (implantable cardioverter-defibrillator) that is known or suspected to be MRI incompatible will be excused from this test.
- Concurrent use of erythropoietin is not allowed while on study therapy.
- Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted. Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
- Patients must not have active, uncontrolled seizure disorder. Patients must not have had a seizure in the last 6 months.
- Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Patients with monoclonal gammopathy of undetermined significance are not eligible.
- Patients must not have grade 2 or higher peripheral neuropathy per CTCAE.
- Patients must not have active, uncontrolled infection.
- Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
- Patients should not have New York Heart Association classification III or IV heart failure at baseline.
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer. For most diseases this time frame is 5 years.
- Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of REMS.
- Women must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.
- Human immunodeficiency virus (HIV)+ patients with undetectable HIV viral loads tested within 6 months are eligible.
- Patients should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.
- Patients must not have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization
Sites / Locations
- Anchorage Associates in Radiation MedicineRecruiting
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Fairbanks Memorial HospitalRecruiting
- CTCA at Western Regional Medical Center
- Kingman Regional Medical Center
- Cancer Center at Saint Joseph'sRecruiting
- Mayo Clinic Hospital in Arizona
- Mayo Clinic in Arizona
- Mercy Hospital Fort SmithRecruiting
- CHI Saint Vincent Cancer Center Hot SpringsRecruiting
- Mission Hope Medical Oncology - Arroyo Grande
- PCR OncologyRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Epic Care-DublinRecruiting
- Bay Area Breast Surgeons IncRecruiting
- Epic Care Partners in Cancer CareRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- Contra Costa Regional Medical CenterRecruiting
- Alta Bates Summit Medical Center - Summit CampusRecruiting
- Bay Area Tumor InstituteRecruiting
- Eisenhower Medical CenterRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Epic Care Cyberknife CenterRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of AuroraRecruiting
- Boulder Community HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - Centennial
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Saint Francis Cancer CenterRecruiting
- Cancer Center of Colorado at Sloan's Lake
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical CenterRecruiting
- Good Samaritan Medical Center
- Saint Anthony HospitalRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical CenterRecruiting
- Longmont United HospitalRecruiting
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical CenterRecruiting
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical CenterRecruiting
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital-Derby Care CenterRecruiting
- Smilow Cancer Hospital Care Center-FairfieldRecruiting
- Smilow Cancer Hospital Care Center at GlastonburyRecruiting
- Smilow Cancer Hospital Care Center - GuifordRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Smilow Cancer Center/Yale-New Haven HospitalRecruiting
- Yale UniversityRecruiting
- Yale-New Haven Hospital North Haven Medical CenterRecruiting
- Smilow Cancer Hospital-Orange Care CenterRecruiting
- Smilow Cancer Hospital-Torrington Care CenterRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- Smilow Cancer Hospital-Waterbury Care CenterRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Holy Cross HospitalRecruiting
- Cleveland Clinic-WestonRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Alphonsus Medical Center-NampaRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Rush - Copley Medical CenterRecruiting
- Loyola Center for Health at Burr Ridge
- Carle on VermilionRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Carle Physician Group-EffinghamRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- Ingalls Memorial HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Loyola Medicine Homer Glen
- Duly Health and Care Joliet
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
- Good Samaritan Regional Health CenterRecruiting
- Illinois Cancer Specialists-NilesRecruiting
- North Shore Medical Center
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Rush-Copley Healthcare Center
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- Springmill Medical Center
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic PC - AmesRecruiting
- McFarland Clinic PC-Boone
- Saint Anthony Regional HospitalRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy Hospital
- Greater Regional Medical CenterRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Medical Oncology and Hematology Associates-LaurelRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Iowa Lutheran HospitalRecruiting
- McFarland Clinic PC-Trinity Cancer Center
- Trinity Regional Medical Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Methodist West HospitalRecruiting
- Mercy Medical Center-West LakesRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- Saint Luke's South Hospital
- Cotton O'Neil Cancer Center / Stormont Vail HealthRecruiting
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Saint Joseph London
- Jewish HospitalRecruiting
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center NortheastRecruiting
- Jewish Hospital Medical Center South
- Hematology/Oncology Clinic PLLC
- Ochsner LSU Health Monroe Medical Center
- Tulane University Health Sciences CenterRecruiting
- Ochsner Medical Center JeffersonRecruiting
- LSU Health Sciences Center at ShreveportRecruiting
- Saint Agnes HospitalRecruiting
- Tufts Medical CenterRecruiting
- Mercy Medical Center
- Hickman Cancer CenterRecruiting
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer Center
- Bronson Battle CreekRecruiting
- IHA Hematology Oncology Consultants-BrightonRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- IHA Hematology Oncology Consultants-CantonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Caro Cancer CenterRecruiting
- IHA Hematology Oncology Consultants-ChelseaRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors Park
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Mercy Health Saint Mary'sRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance HealthRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Sparrow HospitalRecruiting
- Hope Cancer Clinic
- Saint Mary Mercy HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- Toledo Clinic Cancer Centers-Monroe
- Mercy Health Mercy CampusRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Henry Ford Medical Center-ColumbusRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy OaklandRecruiting
- Huron Medical Center PC
- Lake Huron Medical Center
- Spectrum Health Reed City HospitalRecruiting
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Henry Ford Macomb Health Center - Shelby Township
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland HospitalRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Metro Health HospitalRecruiting
- Huron Gastroenterology PC
- IHA Hematology Oncology Consultants-Ann ArborRecruiting
- Riverwood Healthcare Center
- Mayo Clinic Health System in Albert LeaRecruiting
- Essentia Health Saint Joseph's Medical CenterRecruiting
- Fairview Ridges HospitalRecruiting
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical Center
- Mercy HospitalRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Saint Mary's - Detroit Lakes ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Saint Mary's Medical CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Lake Region Healthcare Corporation-Cancer CareRecruiting
- Essentia Health - FosstonRecruiting
- Unity HospitalRecruiting
- Essentia Health Hibbing ClinicRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical Center
- Essentia Health - Park RapidsRecruiting
- Fairview Northland Medical Center
- North Memorial Medical Health CenterRecruiting
- Mayo Clinic in RochesterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Essentia Health SandstoneRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Essentia Health Virginia ClinicRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Fairview Lakes Medical Center
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center Branson
- Siteman Cancer Center at West County HospitalRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Saint Luke's Hospital of Kansas CityRecruiting
- Saint Luke's East - Lee's SummitRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer CenterRecruiting
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess HospitalRecruiting
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community Hospital
- Community Medical HospitalRecruiting
- CHI Health Saint FrancisRecruiting
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical Center
- Nebraska Medicine-Village Pointe
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- University of Nebraska Medical Center
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - Central
- 21st Century OncologyRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Urology Specialists of Nevada - Southwest
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- 21st Century Oncology-Vegas Tenaya
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Comprehensive Cancer Centers of NevadaRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Morristown Medical CenterRecruiting
- Glens Falls HospitalRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- Vidant Oncology-RichlandsRecruiting
- Essentia Health Cancer Center-South University ClinicRecruiting
- Essentia Health - Jamestown ClinicRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Strecker Cancer Center-Belpre
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- Geauga HospitalRecruiting
- Adena Regional Medical CenterRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve UniversityRecruiting
- MetroHealth Medical CenterRecruiting
- Cleveland Clinic FoundationRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors HospitalRecruiting
- Good Samaritan Hospital - Dayton
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Dayton Veterans Affairs Medical CenterRecruiting
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial Hospital
- Dublin Methodist HospitalRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Central Ohio Breast and Endocrine Surgery
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- First Dayton Cancer Care
- Kettering Medical CenterRecruiting
- Fairfield Medical Center
- Saint Rita's Medical CenterRecruiting
- OhioHealth Mansfield HospitalRecruiting
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General Hospital
- UH Seidman Cancer Center at Landerbrook Health CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- Knox Community Hospital
- Licking Memorial HospitalRecruiting
- Newark Radiation OncologyRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Dayton Physicians LLC-Upper ValleyRecruiting
- Upper Valley Medical CenterRecruiting
- Saint Joseph Warren HospitalRecruiting
- Saint Ann's HospitalRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-Ontario
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Geisinger Medical CenterRecruiting
- Pocono Medical CenterRecruiting
- Geisinger Medical Center-Cancer Center HazletonRecruiting
- Lehigh Valley Hospital-Hazleton
- Geisinger Medical Oncology-LewisburgRecruiting
- Lewistown HospitalRecruiting
- Thomas Jefferson University Hospital
- Allegheny General HospitalRecruiting
- West Penn HospitalRecruiting
- Pottstown HospitalRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Community Medical CenterRecruiting
- Geisinger Medical Oncology-SelinsgroveRecruiting
- Geisinger Medical Group
- Reading HospitalRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Smilow Cancer Hospital Care Center - WesterlyRecruiting
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South CarolinaRecruiting
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - FarisRecruiting
- Prisma Health Greenville Memorial HospitalRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Self Regional Healthcare
- Prisma Health Cancer Institute - GreerRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- Avera Cancer Institute
- Saint Joseph Regional Cancer CenterRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- UT Southwestern/Simmons Cancer Center-Fort WorthRecruiting
- M D Anderson Cancer CenterRecruiting
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of UtahRecruiting
- LDS Hospital
- University of Virginia Cancer CenterRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- MultiCare Auburn Medical Center
- Overlake Medical CenterRecruiting
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical CenterRecruiting
- Highline Medical Center-Main CampusRecruiting
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Saint Elizabeth Hospital
- Providence Regional Cancer PartnershipRecruiting
- Saint Francis Hospital
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-LaceyRecruiting
- Saint Clare Hospital
- PeaceHealth Saint John Medical CenterRecruiting
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Valley Medical CenterRecruiting
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard CampusRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- Seattle Cancer Care AllianceRecruiting
- Swedish Medical Center-First HillRecruiting
- Swedish Medical Center-Cherry Hill
- Seattle Cancer Care Alliance at Northwest HospitalRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- PeaceHealth United General Medical CenterRecruiting
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Mary Bridge Children's Hospital and Health Center
- MultiCare Tacoma General Hospital
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Providence Regional Cancer System-Yelm
- United Hospital Center
- West Virginia University Charleston DivisionRecruiting
- WVUH-Berkely Medical Center
- West Virginia University HealthcareRecruiting
- Camden Clark Medical Center
- ThedaCare Regional Cancer CenterRecruiting
- Duluth Clinic AshlandRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Mayo Clinic Health System-Eau Claire ClinicRecruiting
- Aurora Health Center-Fond du LacRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Hospital and ClinicsRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Aurora Sinai Medical CenterRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Marshfield Clinic Stevens Point CenterRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth CareRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (daratumumab, lenalidomide, dexamethasone)
Arm II (lenalidomide, dexamethasone)
Patients receive daratumumab IV on days 1, 8, 15, and 22 of courses 1-2, days 1 and 15 of courses 3-6, and day 1 of courses 7-24. Patients also receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 in courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.