S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration (DRAMMATIC)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Registration Step 1 Except where otherwise indicated below that test is required in a shorter timeframe, all tests for establishing baseline disease status must be completed within 60 days prior to registration. All test results must be documented on the Baseline Tumor Assessment Form for Multiple Myeloma and the Onstudy Form.
Inclusion Criteria
- Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
- Patients with disease measurable by serum light chain assay alone are eligible (defined as >/= 100 mg/L on involved light chain).
- Patients must be registered to Step 1 prior to registration to Step 2. Registration to Step 1 may take place prior to or after autologous stem cell transplant (ASCT), but after completion of induction therapy.
- Patients must have initiated induction therapy within 12 months prior to registration Step 1 and have received at least two cycles of induction therapy.
- Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation).
- Patients must be >/= 18 and </= 75 years of age at time of registration to Step 1.
- Patients must have history and physical exam within 28 days prior to registration.
- Patients must have Zubrod Performance Status </= 2.
- Patients must have evidence of adequate renal function, as defined by (1) creatinine clearance (CrCl) >/= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula, or (2) serum creatinine < 2.5 mg/dL. Values must be obtained within 28 days prior to registration.
Patients must have adequate hepatic function defined by the following within 42 days prior to registration:
- Total bilirubin </=1.5 x IULN (institutional upper limit of the norm) AND
- AST and ALT </=3.0 x IULN
Patients must meet one of the following criteria:
- Be acceptable for transplant per institutional guidelines and the criteria evidencing this must be documented on the S1803 Onstudy Form. (See Appendix 18.3 for standard transplant eligibility guidelines. Note that these are guidelines and not required criteria.) OR
- Have completed autologous stem cell transplant within 180 days prior to registration (see also Section 5.2a).
- Patient's with human immunodeficiency virus (HIV) are eligible providing they are on effective antiretroviral therapy and have undetectable viral load at their most previous viral load test and within 6 months prior to registration.
- Patients must be able to take and swallow oral medication (capsules) whole. Patients may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- For patients who have not yet received transplant: Patients must be willing and able to return to the transplant center for their assigned treatment after randomization. Note that patients need not have a direct relationship with the transplant center in order to register.
- Patients must submit specimens for MRD as outlined in Section 15.1. See Section 15.1 for further information, including specimen submission timepoints. Note that patients are not ineligible based solely on archival specimens being unavailable.
- Patients must be offered participation in specimen banking for future research. With patient's consent, specimens must be submitted as outlined in Section 15.2.
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- As a part of the OPEN registration process (see Section 13.3 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Exclusion Criteria
- Patients with smoldering myeloma are not eligible. Patients with purely non-secretory MM as measured by electrophoresis and immunofixation and the absence of Bence Jones proteins in the urine are not eligible. Patients must have measurable M protein in the serum (defined as >/= 0.5g/dL) or urine (defined as >/= 200 mg/24h). Patients with plasma cell leukemia are not eligible.
- Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
- Patients must not have progressive disease at any time prior to registration.
- Patients must not be refractory to either lenalidomide or daratumumab/rHuPH20.
- Patients must not be intolerant to either lenalidomide or daratumumab/rHuPH20.
- Patients must not have received any investigational agents within 14 days prior to registration.
- Patients must not have chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. FEV1 is required for patients suspected of having chronic obstructive pulmonary disease and are not eligible if FEV1 is < 50% of predicted normal.
- Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
- Patients must not have had prior autograft or allograft, or prior organ transplant requiring immunosuppressive therapy.
- Patients must not have known allergy to any of the study drugs.
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment are not eligible.
- Patients must not have known central nervous system (CNS) involvement with multiple myeloma, defined as CSF positivity for plasma cells at any time or a parenchymal CNS plasmacytoma at time of enrollment. Lumbar puncture is not required.
- Patients must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). HCV testing is only required if clinically indicated or if the patient has a history of HCV.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
- Patients must not have any uncontrolled intercurrent illness including (not limited to): Symptomatic CHF (NYHA III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration, Unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade >/= 2), intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>/= Grade 3), or known psychiatric illness that would limit study compliance.
Registration Step 2 - First Randomization (Post-ASCT, Pre-Maintenance)
Inclusion Criteria:
- Patients must have completed ASCT within 180 days prior to registering to Step 2.
- Patients must have one of the following performed within 60 days prior to registration for disease assessment: diagnostic quality skeletal survey, whole body CT scan, MRI, or PET.
- Patients must have Zubrod Performance Status </= 2
- Patients must have adequate bone marrow function as evidenced by platelets >/= 75,000/mm3 and ANC >/= 1,000/mm3 within 28 days prior to first randomization:
- Patients must have adequate hepatic function defined by the following within 28 days prior to first randomization:
- Total bilirubin </=1.5 x IULN (institutional upper limit of the norm) AND AST and ALT </=3.0 x IULN
- Patients must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) >/= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula, or have a serum creatinine < 2.5 mg/dL within 28 days prior to first randomization.
- All ASCT-related toxicities must have recovered to </=Grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization.
- Mucositis and gastrointestinal symptoms must have resolved to </=Grade 1.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration.
- FCBP must agree to have a second pregnancy test within 24 hours prior to starting Cycle 1. Further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing and must agree to not become pregnant for at least 3 months after the last dose of study treatment.
- Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 3 months after the last dose of study treatment.
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
- Patients must not have received any other maintenance therapy post-ASCT and prior to Step 2 registration.
- Patients must not have had progressive disease between induction and registration to Registration Step 2. (See Section 10.1b).
Registration Step 3 - Second Randomization (Post 24 Months Maintenance)
Inclusion Criteria:
- Patients must have completed 24 cycles of protocol maintenance with either lenalidomide or lenalidomide + daratumumab/rHuPH20.
- Patients must have 24-month MRD by NGS test results available and must be MRD negative. Patients whose PCR results are indeterminable will be considered to have positive results.
- Patients must be in very good partial remission (VGPR) or better by IMWG response criteria (see Section 10.1b).
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Cancer Center at Saint Joseph's
- Mayo Clinic Hospital in Arizona
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Anaheim
- Kaiser Permanente-Deer Valley Medical Center
- Mission Hope Medical Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mercy Cancer Center �� Carmichael
- Mercy San Juan Medical Center
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Kaiser Permanente Dublin
- Mercy Cancer Center - Elk Grove
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fontana
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- Kaiser Permanente - Harbor City
- City of Hope at Irvine Lennar
- Kaiser Permanente-Irvine
- UCI Health Laguna Hills
- Kaiser Permanente Los Angeles Medical Center
- Kaiser Permanente West Los Angeles
- Cedars Sinai Medical Center
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Kaiser Permanente-Modesto
- Providence Queen of The Valley
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Kaiser Permanente-Ontario
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Desert Regional Medical Center
- Kaiser Permanente - Panorama City
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente- Marshall Medical Offices
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Riverside
- Mercy Cancer Center - Rocklin
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- Kaiser Permanente Downtown Commons
- Mercy Cancer Center - Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- Naval Medical Center -San Diego
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San Marcos
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Mission Hope Medical Oncology - Santa Maria
- Kaiser Permanente-Santa Rosa
- Providence Medical Foundation - Santa Rosa
- Providence Santa Rosa Memorial Hospital
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Epic Care Cyberknife Center
- Kaiser Permanente-Woodland Hills
- Woodland Memorial Hospital
- Rocky Mountain Regional VA Medical Center
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Saint Francis Cancer Center
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- Mercy Medical Center
- Southwest Oncology PC
- Kaiser Permanente-Rock Creek
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- Beebe South Coastal Health Campus
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- AdventHealth Altamonte
- AdventHealth Celebration
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Regional Cancer Center-Lee Memorial Health System
- University of Florida Health Science Center - Gainesville
- UM Sylvester Comprehensive Cancer Center at Hollywood
- AdventHealth Kissimmee
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- UM Sylvester Comprehensive Cancer Center at Kendall
- AdventHealth Medical Group Urology at Orlando
- AdventHealth Orlando
- Orlando Health Cancer Institute
- AdventHealth East Orlando
- UM Sylvester Comprehensive Cancer Center at Plantation
- Moffitt Cancer Center-International Plaza
- Moffitt Cancer Center - McKinley Campus
- Moffitt Cancer Center
- AdventHealth Winter Park
- Northside Hospital
- Hawaii Cancer Care - Westridge
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Island Urology-Hilo
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Advocate Good Shepherd Hospital
- Illinois CancerCare-Bloomington
- Loyola Center for Health at Burr Ridge
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Saint Mary's Hospital
- University of Illinois
- Advocate Illinois Masonic Medical Center
- AMG Crystal Lake - Oncology
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Illinois CancerCare-Dixon
- Advocate Good Samaritan Hospital
- Crossroads Cancer Center
- Advocate Sherman Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Advocate South Suburban Hospital
- Loyola Medicine Homer Glen
- Illinois CancerCare-Kewanee Clinic
- AMG Libertyville - Oncology
- Condell Memorial Hospital
- Illinois CancerCare-Macomb
- Loyola University Medical Center
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
- Good Samaritan Regional Health Center
- Cancer Care Center of O'Fallon
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Advocate Lutheran General Hospital
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Illinois CancerCare - Washington
- IU Health North Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Community Cancer Center East
- Community Cancer Center South
- Community Cancer Center North
- Springmill Medical Center
- Community Howard Regional Health
- Reid Health
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- University of Iowa Healthcare Cancer Services Quad Cities
- McFarland Clinic - Boone
- Saint Anthony Regional Hospital
- Physicians' Clinic of Iowa PC
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- Trinity Regional Medical Center
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- University of Kansas Cancer Center-Overland Park
- University of Kansas Hospital-Westwood Cancer Center
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Hospital
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer Center
- Saint Joseph London
- Jewish Hospital
- The James Graham Brown Cancer Center at University of Louisville
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Saint Joseph Mount Sterling
- Jewish Hospital Medical Center South
- Hematology/Oncology Clinic PLLC
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- LSU Health Sciences Center at Shreveport
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Walter Reed National Military Medical Center
- Boston Medical Center
- Lahey Hospital and Medical Center
- Lahey Medical Center-Peabody
- UMass Memorial Medical Center - University Campus
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- McLaren Cancer Institute-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital - Dearborn
- Henry Ford Medical Center-Fairlane
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Weisberg Cancer Treatment Center
- Beaumont Hospital - Farmington Hills
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Ascension Borgess Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Mid-Michigan Physicians-Lansing
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- McLaren Cancer Institute-Central Michigan
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- Ascension Providence Hospitals - Novi
- Henry Ford Medical Center-Columbus
- McLaren Cancer Institute-Northern Michigan
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- McLaren-Port Huron
- Spectrum Health Reed City Hospital
- Oakland Colon Rectal Associates
- Cancer Care Associates PC
- Comprehensive Medical Center PLLC
- Hematology Oncology Consultants PC
- Oakland Medical Group
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Henry Ford Macomb Health Center - Shelby Township
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Premier Hematology Oncology Care
- Ascension Saint Joseph Hospital
- Munson Medical Center
- Michigan Institute of Urology-Town Center
- William Beaumont Hospital - Troy
- Hematology Oncology Consultants PC-Troy
- 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 Hospital
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- University of Michigan Health - West
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Riverwood Healthcare Center
- Essentia Health - Baxter Clinic
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Essentia Health - Ely Clinic
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Essentia Health - International Falls Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- University of Minnesota/Masonic Cancer Center
- Monticello Cancer Center
- Essentia Health - Moose Lake Clinic
- New Ulm Medical Center
- Essentia Health - Park Rapids
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- Gulfport Memorial Hospital
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- Nebraska Cancer Specialists/Oncology Hematology West PC - Hastings
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Cancer Partners of Nebraska - Pine Lake
- Southeast Nebraska Cancer Center - 68th Street Place
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
- Nebraska Methodist Hospital
- Oncology Associates PC
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Cooper Hospital University Medical Center
- The Valley Hospital-Luckow Pavilion
- Neurosurgeons of New Jersey-Ridgewood
- Valley Hospital
- Valley Health System-Hematology/Oncology
- University of New Mexico Cancer Center
- New Mexico Oncology Hematology Consultants
- NYP/Weill Cornell Medical Center
- Rochester General Hospital
- University of Rochester
- Stony Brook University Medical Center
- AdventHealth Infusion Center Asheville
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Southeastern Medical Oncology Center-Clinton
- AdventHealth Infusion Center Haywood
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- East Carolina University
- AdventHealth Hendersonville
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- Levine Cancer Institute - Union West
- Atrium Health Union/LCI-Union
- FirstHealth of the Carolinas-Moore Regional Hospital
- Vidant Oncology-Richlands
- AdventHealth Infusion Center Weaverville
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford South University Medical Center
- Southpointe-Sanford Medical Center Fargo
- Sanford Medical Center Fargo
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Essentia Health - Jamestown Clinic
- UHHS-Chagrin Highlands Medical Center
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Saint Elizabeth Boardman Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geauga Hospital
- Adena Regional Medical Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Dayton Blood and Cancer Center
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Dayton Veterans Affairs Medical Center
- Delaware Health Center-Grady Cancer Center
- Grady Memorial Hospital
- Columbus Oncology and Hematology Associates
- Dublin Methodist Hospital
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Central Ohio Breast and Endocrine Surgery
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Mount Carmel Grove City Hospital
- Zangmeister Center Grove City
- Cleveland Clinic Cancer Center Independence
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- OhioHealth Mansfield Hospital
- Cleveland Clinic Cancer Center Mansfield
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Landerbrook Health Center
- UH Seidman Cancer Center at Southwest General Hospital
- Knox Community Hospital
- Mount Carmel New Albany Surgical Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Mercy Health Perrysburg Cancer Center
- Southern Ohio Medical Center
- North Coast Cancer Care
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- Saint Vincent Mercy Medical Center
- Mercy Health - Saint Anne Hospital
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- South Pointe Hospital
- Saint Joseph Warren Hospital
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- Wright-Patterson Medical Center
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Kaiser Sunnyside Medical Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Three Rivers Community Hospital
- Rogue Valley Medical Center
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Oregon Health and Science University
- Portland VA Medical Center
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Pocono Medical Center
- Lehigh Valley Hospital-Hazleton
- Penn State Milton S Hershey Medical Center
- University of Pennsylvania/Abramson Cancer Center
- Geisinger Wyoming Valley/Henry Cancer Center
- Ralph H Johnson VA Medical Center
- Medical University of South Carolina
- McLeod Regional Medical Center
- Saint Francis Hospital
- Saint Francis Cancer Center
- Levine Cancer Institute-Rock Hill
- Avera Cancer Institute
- Regional One Health
- University of Tennessee Health Science Center
- Saint Joseph Regional Cancer Center
- Houston Methodist Hospital
- M D Anderson Cancer Center
- Houston Methodist Sugar Land Hospital
- Huntsman Cancer Institute/University of Utah
- Virginia Commonwealth University/Massey Cancer Center
- Providence Regional Cancer System-Aberdeen
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Providence Regional Cancer System-Yelm
- United Hospital Center
- WVUH-Berkely Medical Center
- West Virginia University Healthcare
- Camden Clark Medical Center
- ThedaCare Regional Cancer Center
- Ascension Saint Elizabeth Hospital
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
- Aurora Cancer Care-Southern Lakes VLCC
- Ascension Calumet Hospital
- Aurora Saint Luke's South Shore
- Marshfield Medical Center-EC Cancer Center
- Mayo Clinic Health System-Eau Claire Clinic
- Mayo Clinic Health System Eau Claire Hospital-Luther Campus
- Ascension Saint Francis - Reiman Cancer Center
- Ascension Southeast Wisconsin Hospital - Franklin
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Essentia Health-Hayward Clinic
- Mercyhealth Hospital and Cancer Center - Janesville
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- University of Wisconsin Carbone Cancer Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Ascension Columbia Saint Mary's Hospital Ozaukee
- Aurora Cancer Care-Milwaukee
- Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
- Ascension Columbia Saint Mary's Hospital - Milwaukee
- Ascension Saint Francis Hospital
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Froedtert and MCW Moorland Reserve Health Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Ascension Mercy Hospital
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension All Saints Hospital
- Aurora Cancer Care-Racine
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Essentia Health-Spooner Clinic
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Essentia Health Saint Mary's Hospital - Superior
- Vince Lombardi Cancer Clinic-Two Rivers
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- ThedaCare Cancer Care - Waupaca
- Ascension Medical Group Southeast Wisconsin - Mayfair Road
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
- Billings Clinic-Cody
- Welch Cancer Center
- BCCA-Vancouver Cancer Centre
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- Kingston Health Sciences Centre
- Lakeridge Health Oshawa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
No Intervention
Active Comparator
Experimental
Active Comparator
No Intervention
Active Comparator
No Intervention
Study Entry / Screening
Arm 1: Lenalidomide
Arm 2: Lenalidomide + Daratumumab/rHuPH20
Arm 1a: Continue Lenalidomide
Arm 1b: Stop Lenalidomide
Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20
Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20
Study entry/screening to follow patient until Maintenance.
Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment.
Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 2 years from starting treatment.
MRD+ or MRD- and randomized to Arm 1a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment.
MRD- and randomized to Arm 1b: Discontinue protocol therapy.
MRD+ or MRD- and randomized to Arm 2a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 7 years from starting treatment.
MRD- and randomized to Arm 2b: Discontinue protocol therapy.