Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Purpose
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
Condition
- Plasma Cell Myeloma
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration - Participants must have measurable disease within 28 days prior to registration as defined by any of the following: - Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200 milligram[mg]/24 hours[hrs]); OR - IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR - Light chain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) - All disease must be assessed and documented on the baseline/pre-registration tumor assessment form - Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration - For Participants Meeting "Frail" Status: - Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible - For Participants Meeting "Frail" Status: - Hemoglobin >= 7 g/dL (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Frail" Status: - Platelets >= 50 x 10^9/L (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Frail" Status: - Absolute neutrophil count (ANC) >= 0.75 x10^9/L (must be performed within 28 days prior to registration) - Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) - For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present: - Kidney dysfunction showing calculated creatinine clearance (CrCl) <30 ml/min. - Actual lab serum creatinine value with a minimum of 0.7 mg/dL. - Participants must have bone marrow function assessed and meet the below criteria ranges: - Hemoglobin between 7-8 g/dL, OR - Platelets between 50-75 x10^9/L, OR - ANC between 0.75-1 x10^9/L - Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM) - Revised International Staging System (R-ISS) stage III disease - Note: All labs must be performed within 28 days prior to registration - Participants must have a complete medical history and physical exam within 28 days prior to registration - Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form. - Total bilirubin =< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 × institutional ULN (within 28 days prior to registration) - Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4 - Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C > 7 - Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration - All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration - Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration - Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score [PS] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed) - Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system - Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study - Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Exclusion Criteria
- Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following: - An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or - Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or - Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol. - Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration - Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =< 140 and DBP =< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator. - Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. - Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (VRd-Lite) |
INDUCTION CYCLES 1-9: Patients receive bortezomib SC on days 1, 8, 15, and 22 of each cycle, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
|
Experimental Arm II (DRd-R) |
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
|
Experimental Arm III (DRd-DR): |
INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Anchorage, Alaska 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504
Anchorage, Alaska 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Women's Cancer Care
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage Oncology Centre
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Katmai Oncology Group
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Providence Alaska Medical Center
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Phoenix, Arizona 85004
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373
Site Public Contact
800-378-9373
CARTI Cancer Center
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Burbank, California 91505
Mercy Cancer Center �� Carmichael
Carmichael, California 95608
Carmichael, California 95608
Mercy San Juan Medical Center
Carmichael, California 95608
Carmichael, California 95608
Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Elk Grove, California 95758
Fremont - Rideout Cancer Center
Marysville, California 95901
Marysville, California 95901
Contact:
Site Public Contact
530-749-4400
Site Public Contact
530-749-4400
Providence Queen of The Valley
Napa, California 94558
Napa, California 94558
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Mercy Cancer Center - Rocklin
Rocklin, California 95765
Rocklin, California 95765
Mercy Cancer Center - Sacramento
Sacramento, California 95816
Sacramento, California 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
San Luis Obispo, California 93401
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
Santa Maria, California 93444
Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
Santa Rosa, California 95403
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405
Santa Rosa, California 95405
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450
Site Public Contact
530-582-6450
Woodland Memorial Hospital
Woodland, California 95695
Woodland, California 95695
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Saint Francis Cancer Center
Colorado Springs, Colorado 80923
Colorado Springs, Colorado 80923
Porter Adventist Hospital
Denver, Colorado 80210
Denver, Colorado 80210
Mercy Medical Center
Durango, Colorado 81301
Durango, Colorado 81301
Southwest Oncology PC
Durango, Colorado 81301
Durango, Colorado 81301
Saint Anthony Hospital
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Littleton Adventist Hospital
Littleton, Colorado 80122
Littleton, Colorado 80122
Longmont United Hospital
Longmont, Colorado 80501
Longmont, Colorado 80501
Parker Adventist Hospital
Parker, Colorado 80138
Parker, Colorado 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
Pueblo, Colorado 81004
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
Derby, Connecticut 06418
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824
Fairfield, Connecticut 06824
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
Glastonbury, Connecticut 06033
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
Greenwich, Connecticut 06830
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437
Guilford, Connecticut 06437
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
Hartford, Connecticut 06105
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Yale University
New Haven, Connecticut 06520
New Haven, Connecticut 06520
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06473
North Haven, Connecticut 06473
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902
Stamford, Connecticut 06902
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
Torrington, Connecticut 06790
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
Trumbull, Connecticut 06611
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Waterford, Connecticut 06385
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Jupiter Medical Center
Jupiter, Florida 33458
Jupiter, Florida 33458
Contact:
Site Public Contact
561-745-5768
Site Public Contact
561-745-5768
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Nampa, Idaho 83686
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Saint Anthony's Health
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-5623
Site Public Contact
618-463-5623
Rush - Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Saint Joseph Medical Center
Bloomington, Illinois 61701
Bloomington, Illinois 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois 60527
Burr Ridge, Illinois 60527
Contact:
Site Public Contact
708-216-9000
Site Public Contact
708-216-9000
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Carbondale, Illinois 62902
SIH Cancer Institute
Carterville, Illinois 62918
Carterville, Illinois 62918
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831
Site Public Contact
309-344-2831
Loyola Medicine Homer Glen
Homer Glen, Illinois 60491
Homer Glen, Illinois 60491
Contact:
Site Public Contact
708-216-9000
Site Public Contact
708-216-9000
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Loyola University Medical Center
Maywood, Illinois 60153
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357
Site Public Contact
708-226-4357
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois 60160
Melrose Park, Illinois 60160
Contact:
Site Public Contact
708-450-4554
Site Public Contact
708-450-4554
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600
Site Public Contact
618-242-4600
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Valley Radiation Oncology
Peru, Illinois 61354
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141
Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
The Carle Foundation Hospital
Urbana, Illinois 61801
Urbana, Illinois 61801
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Yorkville, Illinois 60560
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52402
Contact:
Site Public Contact
319-297-2900
Site Public Contact
319-297-2900
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Clive, Iowa 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa 51503
Council Bluffs, Iowa 51503
Greater Regional Medical Center
Creston, Iowa 50801
Creston, Iowa 50801
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Mission Cancer and Blood - Laurel
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Garden City, Kansas 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Great Bend, Kansas 67530
Flaget Memorial Hospital
Bardstown, Kentucky 40004
Bardstown, Kentucky 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
Corbin, Kentucky 40701
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Saint Joseph Hospital East
Lexington, Kentucky 40509
Lexington, Kentucky 40509
Saint Joseph London
London, Kentucky 40741
London, Kentucky 40741
Saint Joseph Mount Sterling
Mount Sterling, Kentucky 40353
Mount Sterling, Kentucky 40353
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Saint Joseph Mercy Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Caro Cancer Center
Caro, Michigan 48723
Caro, Michigan 48723
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Ascension Saint John Hospital
Detroit, Michigan 48236
Detroit, Michigan 48236
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
East China Township, Michigan 48054
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Flint, Michigan 48503
Genesee Hematology Oncology PC
Flint, Michigan 48503
Flint, Michigan 48503
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Flint, Michigan 48503
Hurley Medical Center
Flint, Michigan 48503
Flint, Michigan 48503
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Sparrow Hospital
Lansing, Michigan 48912
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-9400
Site Public Contact
517-364-9400
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
Macomb, Michigan 48044
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
Marlette, Michigan 48453
21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Hope Cancer Center
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Saginaw, Michigan 48601
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Saginaw, Michigan 48604
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
Sterling Heights, Michigan 48312
Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Tawas City, Michigan 48764
Advanced Breast Care Center PLLC
Warren, Michigan 48088
Warren, Michigan 48088
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
Warren, Michigan 48093
Macomb Hematology Oncology PC
Warren, Michigan 48093
Warren, Michigan 48093
Michigan Breast Specialists-Warren
Warren, Michigan 48093
Warren, Michigan 48093
Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Warren, Michigan 48093
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
West Branch, Michigan 48661
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48106
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Cambridge Medical Center
Cambridge, Minnesota 55008
Cambridge, Minnesota 55008
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Health Partners Inc
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
New Ulm Medical Center
New Ulm, Minnesota 56073
New Ulm, Minnesota 56073
Fairview Northland Medical Center
Princeton, Minnesota 55371
Princeton, Minnesota 55371
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Robbinsdale, Minnesota 55422
Mayo Clinic in Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
Lakeview Hospital
Stillwater, Minnesota 55082
Stillwater, Minnesota 55082
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
Thief River Falls, Minnesota 56701
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Ridgeview Medical Center
Waconia, Minnesota 55387
Waconia, Minnesota 55387
Rice Memorial Hospital
Willmar, Minnesota 56201
Willmar, Minnesota 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
Sanford Cancer Center Worthington
Worthington, Minnesota 56187
Worthington, Minnesota 56187
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Fairview Lakes Medical Center
Wyoming, Minnesota 55092
Wyoming, Minnesota 55092
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058
Site Public Contact
314-251-7058
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Bolivar, Missouri 65613
Cox Cancer Center Branson
Branson, Missouri 65616
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Southeast Cancer Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550
Site Public Contact
573-651-5550
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Capital Region Southwest Campus
Jefferson City, Missouri 65109
Jefferson City, Missouri 65109
Freeman Health System
Joplin, Missouri 64804
Joplin, Missouri 64804
Mercy Hospital Joplin
Joplin, Missouri 64804
Joplin, Missouri 64804
Lake Regional Hospital
Osage Beach, Missouri 65065
Osage Beach, Missouri 65065
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379
Site Public Contact
573-458-6379
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Saint Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870
Site Public Contact
314-353-1870
Mercy Hospital South
Saint Louis, Missouri 63128
Saint Louis, Missouri 63128
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
CoxHealth South Hospital
Springfield, Missouri 65807
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Washington
Washington, Missouri 63090
Washington, Missouri 63090
Contact:
Site Public Contact
636-390-1600
Site Public Contact
636-390-1600
Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Missoula, Montana 59802
CHI Health Good Samaritan
Kearney, Nebraska 68847
Kearney, Nebraska 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
Omaha, Nebraska 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
Omaha, Nebraska 68130
Creighton University Medical Center
Omaha, Nebraska 68131
Omaha, Nebraska 68131
Midlands Community Hospital
Papillion, Nebraska 68046
Papillion, Nebraska 68046
University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Sanford South University Medical Center
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Contact:
Site Public Contact
701-234-6161
Site Public Contact
701-234-6161
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Sanford Medical Center Fargo
Fargo, North Dakota 58104
Fargo, North Dakota 58104
Contact:
Site Public Contact
800-437-4010
Site Public Contact
800-437-4010
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Bethesda North Hospital
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
Cincinnati, Ohio 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
Cincinnati, Ohio 45255
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402
Site Public Contact
405-752-3402
Saint Charles Health System
Bend, Oregon 97701
Bend, Oregon 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Bay Area Hospital
Coos Bay, Oregon 97420
Coos Bay, Oregon 97420
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Oregon City, Oregon 97045
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Saint Charles Health System-Redmond
Redmond, Oregon 97756
Redmond, Oregon 97756
Contact:
Site Public Contact
541-706-2909
Site Public Contact
541-706-2909
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
East Stroudsburg, Pennsylvania 18301
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
Hazleton, Pennsylvania 18201
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island 02891
Westerly, Rhode Island 02891
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
Boiling Springs, South Carolina 29316
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Easley, South Carolina 29640
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Greer, South Carolina 29650
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota 57401
Aberdeen, South Dakota 57401
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Avera Cancer Institute
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Avera Cancer Institute at Yankton
Yankton, South Dakota 57078
Yankton, South Dakota 57078
Sovah Health Martinsville
Martinsville, Virginia 24115
Martinsville, Virginia 24115
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
Aberdeen, Washington 98520
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Bellingham, Washington 98225
Contact:
Site Public Contact
360-788-8223
Site Public Contact
360-788-8223
Harrison Medical Center
Bremerton, Washington 98310
Bremerton, Washington 98310
Providence Regional Cancer System-Centralia
Centralia, Washington 98531
Centralia, Washington 98531
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Edmonds, Washington 98026
Providence Regional Cancer Partnership
Everett, Washington 98201
Everett, Washington 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Issaquah, Washington 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
Kennewick, Washington 99336
Providence Regional Cancer System-Lacey
Lacey, Washington 98503
Lacey, Washington 98503
PeaceHealth Saint John Medical Center
Longview, Washington 98632
Longview, Washington 98632
Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
Seattle, Washington 98107
Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
Seattle, Washington 98122-5711
Swedish Medical Center-First Hill
Seattle, Washington 98122
Seattle, Washington 98122
PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
Sedro-Woolley, Washington 98284
Providence Regional Cancer System-Shelton
Shelton, Washington 98584
Shelton, Washington 98584
PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Vancouver, Washington 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
Walla Walla, Washington 99362
Providence Regional Cancer System-Yelm
Yelm, Washington 98597
Yelm, Washington 98597
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Appleton, Wisconsin 54911
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
More Details
- NCT ID
- NCT05561387
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
Detailed Description
PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) in frail or selected intermediate fit newly diagnosed multiple myeloma (NDMM) participants treated with bortezomib with lenalidomide and dexamethasone at reduced dosing (VRd-Lite) induction followed by lenalidomide maintenance (Arm 1) versus daratumumab and hyaluronidase-fihj with lenalidomide and dexamethasone (DRd) induction followed by lenalidomide maintenance (Arm 2). II. To compare overall survival (OS) in frail or selected intermediate fit NDMM participants treated with VRd-Lite induction followed by lenalidomide maintenance (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and hyaluronidase-fihj maintenance (Arm 3). SECONDARY OBJECTIVES: I. To compare PFS in Arm 1 versus Arm 3 II. To compare OS in Arm 1 versus Arm 2. III. To compare PFS in Arm 2 versus 3. IV. To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3. V. To compare the safety of Arm 1 with the safety of Arm 2 and Arm 3. VI. To explore veinous thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms. VII. To describe median time to response (complete response [CR] or better per International Myeloma Working Group [IMWG] criteria, very good partial response [VGPR] or better per IMWG criteria, partial response [PR] or better per IMWG criteria) on the three study arms. PRIMARY QUALITY OF LIFE (QOL) OBJECTIVE: I. To compare patient-reported global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) at 9 months after randomization (end of induction therapy) using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30). SECONDARY QOL OBJECTIVE: II. To compare longitudinal changes in global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) from baseline to 9 months after randomization (end of induction therapy). PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE: I. To compare selected patient-reported outcome symptoms using PRO-CTCAE items among the 3 study arms. ADDITIONAL OBJECTIVES: I. To compare the rate of minimal residual disease (MRD) by clonoSEQ after 9 cycles of induction in Arm 1 versus Arm 2 and Arm 3, respectively. II. To compare the rate of MRD conversion after 1 year of maintenance in participants who were MRD positive after induction in Arm 1 versus Arm 2 and Arm 3, respectively. III. To compare the rate of sustained MRD negativity at time points of post-induction, post-1 year maintenance in Arm 1 versus Arm 2 and Arm 3, respectively. BANKING OBJECTIVES: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I (VRd-Lite): INDUCTION CYCLES 1-9: Patients receive bortezomib subcutaneously (SC) on days 1, 8, 15, and 22 of each cycle, lenalidomide orally (PO) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II (DRd-R): INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM III (DRd-DR): INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.